Clinical Review & Education
Clinical Challenges in Otolaryngology
Post-FESS Middle Meatal Dressings Avoiding the Inevitable? Zachary M. Soler, MD, MSc; Rodney J. Schlosser, MD
HYPOTHESIS Use of dressings in the middle meatus after functional endoscopic sinus surgery (FESS) improves clinically meaningful outcomes in patients with chronic rhinosinusitis (CRS). JAMA Otolaryngol Head Neck Surg. 2013;139(12):1351-1354. doi:10.1001/jamaoto.2013.5439 Published online October 31, 2013.
Background Interest in middle meatal dressings has persisted over the last 50 years despite dramatic changes in surgical technique and available technologies.1 Presently, most surgery for CRS is accomplished using endoscopic instrumentation with the goals of enlarging the sinus ostia, improving mucociliary transport, and optimizing delivery of medications to the sinus mucosa. Although the extent of surgery is often patient specific, FESS invariably requires instruments to pass through the middle meatus between the middle turbinate and the lateral nasal wall. Mucosa of the middle meatus will be disturbed by intended maneuvers such as uncinate resection or ethmoidectomy as well as the unintended friction of moving instruments in and out of this region. Disrupted mucosa can result in bleeding, both intraoperative and delayed, and may result in synechiae formation if abraded structures are in close apposition. Perforation of the basal lamella during posterior ethmoid or sphenoid surgery can also destabilize the middle turbinate, allowing it possibly to lateralize postoperatively. A middle meatal dressing can have several purposes: (1) it acts as a physical barrier to prevent synechiae formation or middle turbinate lateralization; (2) it promotes epithelialization and wound healing; (3) it promotes hemostasis; and (4) it facilitates drug delivery. Dressings that physically separate the mucosa of the middle turbinate from that of the lateral nasal wall and orbit are intended to prevent synechiae formation and in some instances may help ensure that the middle turbinate is maintained in a nonlateralized position. These dressings typically must remain in place for 5 to 7 days during early wound healing. Other dressings have been used to hasten reepithelialization, thus preventing synechiae. In some instances, dressings may be used to help obtain hemostasis at the conclusion of surgery or possibly to decrease the likelihood of delayed hemorrhage. These dressings typically provide some degree of tamponade, or alternatively they provide some scaffolding or matrix for clot formation. Recently, dressings have also been used to deliver topical medications directly to the sinus mucosa in a delayed-release manner, including antiinflammatory and antimicrobial agents. Most dressings serve more than one of these purposes, such as the traditional nasal sponge, which expands to fill the ethmoid cavity. A sponge acts as a physical barrier to prevent synechiae formation and also expands, thus providing pressure for middle turbinate medialization and tamponade for hemostasis. jamaotolaryngology.com
Middle meatal dressings are often categorized as absorbable or nonabsorbable. Absorbable materials can be left in situ to degrade over time or completely or partially removed at the discretion of the surgeon. Nonabsorbable materials require removal in the postoperative period. Dressings are also described as spacers, stents, or implants. The terms Zachary M. Soler, Spacer and stent imply a more rigid mate- MD, MSc rial, whereas dressing suggests a softer substance, but these descriptors are used loosely, and significant heterogeneity exists. For the purposes of this review, we have chosen to use the term dressing to refer to any material placed into the middle meatus after FESS, regardless of its composition or primary purpose. The ideal middle meatal dressing might be expected to be (1) inexpensive, (2) easily placed, (3) biocompatible, (4) free of Rodney J. Schlosser, MD infectious risk, (5) comfortable for the patient, (6) absorbable, and (7) capable of carrying medications if needed. A list of common middle meatal dressings and their properties is provided in the Table.
Methods A wide range of outcome measures have been used to assess the efficacy of middle meatal dressings. These include surgical outcomes such as intraoperative hemostasis and delayed postoperative epistaxis. Other clinical outcomes include the endoscopic appearance of the sinonasal cavity, the presence or absence of synechiae, position of the middle turbinate, and evidence of inflammation (edema or polyps) or infection (purulence). Perhaps the most clinically relevant outcome measure would be patient-reported symptoms and/or impaired quality of life (QOL). However, global patient-reported QOL cannot be assessed in studies wherein patients served as their own controls and intervention was assigned to a single side—a study design used by many authors. For purposes of this review, a PubMed literature search was performed querying endoscopic sinus surgery and use of dressings, spac-
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Post-FESS Middle Meatal Dressings
Table. Common Middle Meatal Dressings Used After FESS Product Name (Company)
RCT—Dressing vs Placebo Absorbable (No Dressing)a
Improvement vs Placebob
Worsening vs Placebo
No Difference vs Placebo
NA
NA
NA
NA
Hemostasis, congestion, pain, headache, infection
NA
NA
NA
Yes17
NA
Ostial obstruction, granulation
Yes
Yes18
NA
NA
Blood
Yes
Yes9
Gelatin, collagen
Animal
Yes
No
Oxidized cellulose
Plant
Yes
No
Hyaluronic acid
Animal
Yes
No
Sepragel sinus (Genzyme Biosurgery)
Hyaluronic acid
Animal
Yes
Yes6,7
Seprapack (Genzyme Biosurgery)
Hyaluronic acid/CMC
Animal/Plant
Yes
Yes16
Sinufoam (Arthrocare)
CMC
Plant
Yes
Yes10,11
MPH (Medafor)
Microporous polysaccharide
Plant
Yes
Yes14,15
Hemostasis
NA
Chitosan gel (Medtronic)
Chitosan/dextran
Animal
Yes
Yes12
Synechiae, hemostasis
NA
NasoPore (Stryker)
Polyurethane foam
Synthetic
Yes
No
NA
NA
NA
Quixil (Omrix)
Thrombin/fibrinogen
Blood
Yes
No
NA
NA
NA
Material
Derivation
Propel implant (Intersect ENT Inc)
Lactide, glycolide and caprolactone copolymers plus mometasone furoate
Synthetic
Yes
No
Merocel (Medtronic)
Polyvinyl alcohol
Synthetic
No
Yes13
Salman stent (Boston Medical)
Silicone
Synthetic
No
No
Gelfilm (Pharmacia and Upjohn)
Gelatin, collagen
Animal
Yes
Gelfoam (Pharmacia and Upjohn
Gelatin, collagen
Animal
Floseal (Baxter International)
Gelatin/thrombin
Surgiflo (Ethicon) Surgicel (Ethicon) MeroGel (Medtronic)
Abbreviations: CMC, carboxymethylcellulose; FESS, functional endoscopic sinus surgery; MPH, microporous polysaccharide hemospheres; NA, not applicable; RCT, randomized clinical trial. a
Hemostasis, pain
Synechiae Synechiae, hemostasis, granulation, edema, crusting, infection
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Synechiae,c pain
NA
Synechiae,c hemostasis, congestion, infection
Congestion
NA
Synechiae
NA
NA Synechiae, congestion, edema, pain, infection, discharge NA
b
Outcome measure improved with middle meatal dressing compared with placebo.
c
Conflicting results among studies.
Human trial in patients with chronic rhinosinusitis undergoing FESS with clinical end points.
Pro
subjective assessment with only fair interrater reliability.4 Perhaps the best evidence for this problem are the numerous techniques proposed to prevent its occurrence, including creating controlled synechiae between the turbinate and septum and techniques to suture the turbinate in a medial position. Finally, postoperative bleeding, both immediate and delayed, represents an undesired complication. Epistaxis severe enough to require clinical attention has been estimated to occur in 1% to 6% of cases across studies.3
Need for Dressings
Outcomes
Middle meatal dressings represent an attempt to address complications encountered with some degree of regularity following FESS. Synechiae formation in the middle meatus is estimated to occur in 0% to 40% of cases, with most authors reporting rates greater than 15%.2 It remains a commonly held belief that scarring negatively impacts outcomes of surgery and predicts need for future revision procedures.3 Lateralization of the middle turbinate is another undesired outcome of surgery because it may increase synechiae formation and limits access into the middle meatus for endoscopic visualization and topical delivery of medications. Precise rates of turbinate lateralization are difficult to estimate because turbinate position remains a
Lee and Grewal5 recently performed a systematic review with metaanalysis of randomized clinical trials (RCTs) evaluating middle meatal dressings used after FESS in adults with CRS. A total of 23 studies were identified, but 15 of the studies compared one type of dressing to another, without an arm for no intervention. This included several studies evaluating the Propel implant (Intersect ENT Inc). Although these studies sometimes showed superiority of one dressing over another, they provided little insight as to whether the superior dressing would be better than no dressing at all. Eight studies compared a specific dressing to no dressing and described at least 1 clinical outcome. Studies were published from 2001 to 2010 and
ers, stents, or implants. Searches were repeated including known materials as key words. References of identified studies were scanned as were prior reviews on the subject. Only controlled clinical studies of human participants with CRS that compared a given dressing to no dressing were included. Those studies comparing one dressing to another dressing were assessed, but superiority of one over another was not equated with superiority to no intervention.
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Synechiae
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Post-FESS Middle Meatal Dressings
Clinical Challenges in Otolaryngology Clinical Review & Education
included absorbable (Sepragel Sinus [Genzyme Biosurgery],6,7 Merogel [Medtronic],8 Floseal [Baxter International],9 carboxymethylcellulose (CMC) net/gel,10,11 Chitosan gel [Medtronic]12) and nonabsorbable (Merocel [Medtronic]13) materials. Additional RCTs not included in their review were identified that evaluated microporous polysaccharide hemospheres (MPH),14,15 Seprapack [Genzyme Biosurgery],16 Gelfilm [Pharmacia and Upjohn],17 and Gelfoam [Pharmacia and Upjohn]18 dressings. When synechiae prevention was evaluated via meta-analysis, the use of dressings was found to result in a nonsignificant trend toward less synechiae formation, with a summary risk ratio (RR) equal to 0.4 (95% CI, 0.14-1.12). As might be expected, there was significant heterogeneity among types of dressings. The single study evaluating the nonabsorbable dressing Merocel found a significant improvement in synechiae (RR, 0.21 [95% CI, 0.10-0.44]).13 Subgroup analysis pooling data from the 3 studies evaluating absorbable dressings failed to show a significant reduction (P = .44).8,10,12 Of the absorbable dressings, Chitosan gel resulted in less synechiae formation than no dressing (RR, 0.17 [95% CI, 0.04-0.69]).12 Studies evaluating hyaluronic acid dressings had mixed results, with one study demonstrating a reduction in synechiae scores7 and the other studies showing no difference compared with controls.6,8,16 None of the studies showed long-term (>1 month) improvements in mucosal appearance, including crusting, granulation tissue, or edema and/or polyps.6-18 Three RCTs have evaluated the ability of absorbable dressings to improve intraoperative hemostasis at the conclusion of surgery.6,9,12 Chitosan gel resulted in hemostasis at an average of 2 minutes vs 10 minutes for no dressing12 and Floseal demonstrated a similar effect, resulting in cessation of bleeding after 16 minutes compared with 31 minutes in controls.9 In contrast, Sepragel Sinus failed to show a difference in immediate hemostasis.6 Several studies that looked at delayed postoperative bleeding in the weeks following FESS failed to show a significant difference for Merocel, CMC, MeroGel, and Floseal dressings.8,9,11,13 Visual analog scale scores for bleeding on postoperative day 1 were reduced by MPH compared with control (22.5 vs 39; P < .001). However, the clinical relevance of 16.5 points on this 0-100 scale is uncertain (a score of 50 meant bleeding requiring occasional change of drip pad), and no other time points showed significant findings.15 Sinus-specific symptoms and QOL are arguably the gold standard outcome metrics for FESS and FESS dressings. Unfortunately, none of the reviewed controlled clinical trials evaluating middle meatal dressings reported long-term QOL or symptom-specific data. Several studies have evaluated short-term pain and congestion, with conflicting results. No difference in pain scores was found between patients with and without Merocel. Floseal dressing resulted in less pain compared with sides without dressing in the week following surgery.9 Similarly, Sepragel Sinus resulted in less pain in week 2 only but no difference in congestion at any time.7 Seprapack resulted in less congestion at 8 weeks compared with no treatment.16
Con Need for Dressings
It remains a commonly held belief that middle meatal synechiae and/or middle turbinate lateralization can lead to poor outcomes and predict the need for revision surgery. This teaching extends back to jamaotolaryngology.com
the pioneers of FESS and is commonly cited as a reason to use dressings to prevent the middle turbinate from scarring to the lateral nasal wall.19 In a prospective study, middle turbinate lateralization was found in 78% of patients undergoing revision sinus surgery—the most common anatomic finding.20 However, association is not causation, and there remains little direct proof that middle meatal synechiae alone leads to worse outcomes. In some instances the middle turbinate may densely adhere to the lateral nasal wall and orbit, obstructing the frontal recess and/or maxillary sinus. However, in many (if not most) instances, synechiae may not obstruct the sinus ostia or impair nasal airflow, and in these cases they may be of little clinical relevance. In a recent prospective clinical trial of 100 patients undergoing FESS, there was no association between the presence of synechiae and patient symptoms or radiographic findings after an average of 10 years’ follow-up.21 As described above, some middle meatal dressings have been shown to improve immediate hemostasis at the conclusion of FESS. However, significant bleeding is not encountered in most sinus surgeries. A recent review of a national database of 62 000 FESS procedures found significant hemorrhage to occur in less than 1% of cases.22 Orlandi and Lanza23 reported a retrospective case series of 165 patients undergoing FESS, of which none had significant postoperative bleeding. Of the last 91 procedures, 95% had no middle meatal dressing placed at the conclusion of surgery. This study suggests that perioperative systemic steroids, topical vasoconstrictors, localized injections, and meticulous technique may provide adequate short- and long-term hemostasis in the majority of instances. Outcomes
As described above, level 1 evidence exists that some middle meatal dressings reduce synechiae formation (Merocel and Chitosan), and others may improve perioperative hemostasis (Chitosan, Floseal, and MPH). However, none of these studies provide data demonstrating improvement in long-term symptoms, QOL, postoperative hemorrhage, infection rates, or need for revision surgery. It should also be kept in mind that perioperative adjunctive measures were not standardized among studies and oftentimes were not performed. Relevant measures that might reduce bleeding (preoperative steroids, topical vasoconstrictors) and synechiae formation (suturing techniques, saline irrigations, debridements, topical steroids) might further obviate the need for middle meatal dressings.
Bottom Line No currently available material possesses all of the characteristics of the ideal middle meatal dressing, nor have any been shown to improve long-term outcomes after surgery compared with no intervention. Based on available evidence, the placement of a middle meatal dressing appears unnecessary after most FESS procedures. In specific instances where bleeding persists at the conclusion of surgery, dressings that excel in hemostasis can be considered, such as Chitosan, Floseal, or MPH. If there is concern that the middle turbinate is unstable and/or has been overly traumatized, dressings that minimize synechiae formation may be considered, including Merocel and Chitosan. With the past as a guide, the future will surely see the introduction of novel middle meatal dressings, supplementing those already available. Surgeons should remain prudent regarding their use and continue to demand placebo-controlled evidence that dressings improve clinically meaningful outcomes after FESS.
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ARTICLE INFORMATION Author Affiliations: Division of Rhinology and Sinus Surgery, Department of Otolaryngology–Head and Neck Surgery, Medical University of South Carolina, Charleston. Corresponding Author: Rodney J. Schlosser, MD, Division of Rhinology and Sinus Surgery, Department of Otolaryngology–Head and Neck Surgery, Medical University of South Carolina, 171 Ashley Ave, Charleston, SC 29425 ([email protected]). Section Editor: Marion Boyd Gillespie, MD, MSc. Submitted for Publication: July 20, 2012; final revision received March 27, 2013; accepted September 15, 2013. Published Online: October 31, 2013. doi:10.1001/jamaoto.2013.5439. Author Contributions: Drs Soler and Schlosser had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Both authors. Acquisition of data: Soler. Analysis and interpretation of data: Soler. Drafting of the manuscript: Both authors. Critical revision of the manuscript for important intellectual content: Both authors. Statistical analysis: Soler. Study supervision: Schlosser. Conflict of Interest Disclosures: None reported. REFERENCES 1. Stevens RW. Nasal packing; the rubber pneumatic pack. AMA Arch Otolaryngol. 1951;54(2):191-194. 2. Weitzel EK, Wormald PJ. A scientific review of middle meatal packing/stents. Am J Rhinol. 2008;22(3):302-307. 3. Valentine R, Wormald PJ. Nasal dressings after endoscopic sinus surgery: what and why? Curr Opin Otolaryngol Head Neck Surg. 2010;18(1):44-48. 4. McCoul ED, Smith TL, Mace JC, et al. Interrater agreement of nasal endoscopy in patients with a
Clinical Review & Education
prior history of endoscopic sinus surgery. Int Forum Allergy Rhinol. 2012;2(6):453-459. 5. Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol. 2012;2(6):477-486. 6. Frenkiel S, Desrosiers MY, Nachtigal D. Use of hylan B gel as a wound dressing after endoscopic sinus surgery. J Otolaryngol. 2002;31(Suppl 1): S41-S44. 7. Kimmelman CP, Edelstein DR, Cheng HJ. Sepragel sinus (hylan B) as a postsurgical dressing for endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2001;125(6):603-608. 8. Wormald PJ, Boustred RN, Le T, Hawke L, Sacks R. A prospective single-blind randomized controlled study of use of hyaluronic acid nasal packs in patients after endoscopic sinus surgery. Am J Rhinol. 2006;20(1):7-10. 9. Jameson M, Gross CW, Kountakis SE. FloSeal use in endoscopic sinus surgery: effect on postoperative bleeding and synechiae formation. Am J Otolaryngol. 2006;27(2):86-90. 10. Kastl KG, Betz CS, Siedek V, Leunig A. Control of bleeding following functional endoscopic sinus surgery using carboxy-methylated cellulose packing. Eur Arch Otorhinolaryngol. 2009;266(8):1239-1243. 11. Kastl KG, Betz CS, Siedek V, Leunig A. Effect of carboxymethylcellulose nasal packing on wound healing after functional endoscopic sinus surgery. Am J Rhinol Allergy. 2009;23(1):80-84. 12. Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010;24(1):70-75. 13. Bugten V, Nordgård S, Skogvoll E, Steinsvåg S. Effects of nonabsorbable packing in middle meatus after sinus surgery. Laryngoscope. 2006;116(1):83-88.
increase synechiae after sinus surgery: randomized controlled study. Am J Rhinol Allergy. 2011;25(4): 268-271. 15. Antisdel JL, West-Denning JL, Sindwani R. Effect of microporous polysaccharide hemospheres (MPH) on bleeding after endoscopic sinus surgery: randomized controlled study. Otolaryngol Head Neck Surg. 2009;141(3):353-357. 16. Woodworth BA, Chandra RK, Hoy MJ, Lee FS, Schlosser RJ, Gillespie MB. Randomized controlled trial of hyaluronic acid/carboxymethylcellulose dressing after endoscopic sinus surgery. ORL J Otorhinolaryngol Relat Spec. 2010;72(2):101-105. 17. Tom LW, Palasti S, Potsic WP, Handler SD, Wetmore RF. The effects of gelatin film stents in the middle meatus. Am J Rhinol. 1997;11(3):229-232. 18. Wee JH, Lee CH, Rhee CS, Kim JW. Comparison between Gelfoam packing and no packing after endoscopic sinus surgery in the same patients. Eur Arch Otorhinolaryngol. 2012;269(3):897-903. 19. Metson RB, Platt MP. Complications of endoscopic sinus surgery: Prevention and management. In: Kennedy DW, Hwang PH, eds. Rhinology: Diseases of the Nose, Sinuses, and Skull Base. New York, NY: Thieme; 2012. 20. Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004;25(6):418-422. 21. Mus L, Hermans R, Jorissen M. Long-term effects of cutting versus non-cutting instruments in FESS. Rhinology. 2012;50(1):56-66. 22. Ramakrishnan VR, Kingdom TT, Nayak JV, Hwang PH, Orlandi RR. Nationwide incidence of major complications in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2012;2(1):34-39. 23. Orlandi RR, Lanza DC. Is nasal packing necessary following endoscopic sinus surgery? Laryngoscope. 2004;114(9):1541-1544.
14. Antisdel JL, Matijasec JL, Ting JY, Sindwani R. Microporous polysaccharide hemospheres do not
Invited Commentary CLINICAL CHALLENGES IN OTOLARYNGOLOGY
The Role of Middle Meatal Dressings in Endoscopic Sinus Surgery Andrew P. Lane, MD
Outcomes in endoscopic sinus surgery are determined by an interplay of numerous factors, some intrinsic to the patient and others related to management decisions and actions taken by the surgeon before, during, and after surgery. Related article page 1351 There is great variety in the specific perioperative medical regimens and surgical techniques that sinus surgeons employ. This is in part necessitated by the heterogeneity of sinus disease but mainly reflects individual practice prefer1354
ences derived from training, experience, and interpretation of expert recommendations. A relatively small number of these interventions have a strong evidence basis in randomized clinical trials. In formulating treatment plans, we all strive to use our informed clinical judgment to achieve the best results for our patients. One of the numerous decisions faced along the way in the surgical management of sinusitis is the placement of a postsurgical middle meatal dressing. The article by Soler and Schlosser 1 in this issue cogently reviews the current evidence regarding the pros and cons of
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Clinical Challenges in Otolaryngology
Post-FESS Middle Meatal Dressings Avoiding the Inevitable? Zachary M. Soler, MD, MSc; Rodney J. Schlosser, MD
HYPOTHESIS Use of dressings in the middle meatus after functional endoscopic sinus surgery (FESS) improves clinically meaningful outcomes in patients with chronic rhinosinusitis (CRS). JAMA Otolaryngol Head Neck Surg. 2013;139(12):1351-1354. doi:10.1001/jamaoto.2013.5439 Published online October 31, 2013.
Background Interest in middle meatal dressings has persisted over the last 50 years despite dramatic changes in surgical technique and available technologies.1 Presently, most surgery for CRS is accomplished using endoscopic instrumentation with the goals of enlarging the sinus ostia, improving mucociliary transport, and optimizing delivery of medications to the sinus mucosa. Although the extent of surgery is often patient specific, FESS invariably requires instruments to pass through the middle meatus between the middle turbinate and the lateral nasal wall. Mucosa of the middle meatus will be disturbed by intended maneuvers such as uncinate resection or ethmoidectomy as well as the unintended friction of moving instruments in and out of this region. Disrupted mucosa can result in bleeding, both intraoperative and delayed, and may result in synechiae formation if abraded structures are in close apposition. Perforation of the basal lamella during posterior ethmoid or sphenoid surgery can also destabilize the middle turbinate, allowing it possibly to lateralize postoperatively. A middle meatal dressing can have several purposes: (1) it acts as a physical barrier to prevent synechiae formation or middle turbinate lateralization; (2) it promotes epithelialization and wound healing; (3) it promotes hemostasis; and (4) it facilitates drug delivery. Dressings that physically separate the mucosa of the middle turbinate from that of the lateral nasal wall and orbit are intended to prevent synechiae formation and in some instances may help ensure that the middle turbinate is maintained in a nonlateralized position. These dressings typically must remain in place for 5 to 7 days during early wound healing. Other dressings have been used to hasten reepithelialization, thus preventing synechiae. In some instances, dressings may be used to help obtain hemostasis at the conclusion of surgery or possibly to decrease the likelihood of delayed hemorrhage. These dressings typically provide some degree of tamponade, or alternatively they provide some scaffolding or matrix for clot formation. Recently, dressings have also been used to deliver topical medications directly to the sinus mucosa in a delayed-release manner, including antiinflammatory and antimicrobial agents. Most dressings serve more than one of these purposes, such as the traditional nasal sponge, which expands to fill the ethmoid cavity. A sponge acts as a physical barrier to prevent synechiae formation and also expands, thus providing pressure for middle turbinate medialization and tamponade for hemostasis. jamaotolaryngology.com
Middle meatal dressings are often categorized as absorbable or nonabsorbable. Absorbable materials can be left in situ to degrade over time or completely or partially removed at the discretion of the surgeon. Nonabsorbable materials require removal in the postoperative period. Dressings are also described as spacers, stents, or implants. The terms Zachary M. Soler, Spacer and stent imply a more rigid mate- MD, MSc rial, whereas dressing suggests a softer substance, but these descriptors are used loosely, and significant heterogeneity exists. For the purposes of this review, we have chosen to use the term dressing to refer to any material placed into the middle meatus after FESS, regardless of its composition or primary purpose. The ideal middle meatal dressing might be expected to be (1) inexpensive, (2) easily placed, (3) biocompatible, (4) free of Rodney J. Schlosser, MD infectious risk, (5) comfortable for the patient, (6) absorbable, and (7) capable of carrying medications if needed. A list of common middle meatal dressings and their properties is provided in the Table.
Methods A wide range of outcome measures have been used to assess the efficacy of middle meatal dressings. These include surgical outcomes such as intraoperative hemostasis and delayed postoperative epistaxis. Other clinical outcomes include the endoscopic appearance of the sinonasal cavity, the presence or absence of synechiae, position of the middle turbinate, and evidence of inflammation (edema or polyps) or infection (purulence). Perhaps the most clinically relevant outcome measure would be patient-reported symptoms and/or impaired quality of life (QOL). However, global patient-reported QOL cannot be assessed in studies wherein patients served as their own controls and intervention was assigned to a single side—a study design used by many authors. For purposes of this review, a PubMed literature search was performed querying endoscopic sinus surgery and use of dressings, spac-
JAMA Otolaryngology–Head & Neck Surgery December 2013 Volume 139, Number 12
Copyright 2013 American Medical Association. All rights reserved.
Downloaded From: http://archotol.jamanetwork.com/ by a J H Quillen College User on 06/03/2015
1351
Clinical Review & Education Clinical Challenges in Otolaryngology
Post-FESS Middle Meatal Dressings
Table. Common Middle Meatal Dressings Used After FESS Product Name (Company)
RCT—Dressing vs Placebo Absorbable (No Dressing)a
Improvement vs Placebob
Worsening vs Placebo
No Difference vs Placebo
NA
NA
NA
NA
Hemostasis, congestion, pain, headache, infection
NA
NA
NA
Yes17
NA
Ostial obstruction, granulation
Yes
Yes18
NA
NA
Blood
Yes
Yes9
Gelatin, collagen
Animal
Yes
No
Oxidized cellulose
Plant
Yes
No
Hyaluronic acid
Animal
Yes
No
Sepragel sinus (Genzyme Biosurgery)
Hyaluronic acid
Animal
Yes
Yes6,7
Seprapack (Genzyme Biosurgery)
Hyaluronic acid/CMC
Animal/Plant
Yes
Yes16
Sinufoam (Arthrocare)
CMC
Plant
Yes
Yes10,11
MPH (Medafor)
Microporous polysaccharide
Plant
Yes
Yes14,15
Hemostasis
NA
Chitosan gel (Medtronic)
Chitosan/dextran
Animal
Yes
Yes12
Synechiae, hemostasis
NA
NasoPore (Stryker)
Polyurethane foam
Synthetic
Yes
No
NA
NA
NA
Quixil (Omrix)
Thrombin/fibrinogen
Blood
Yes
No
NA
NA
NA
Material
Derivation
Propel implant (Intersect ENT Inc)
Lactide, glycolide and caprolactone copolymers plus mometasone furoate
Synthetic
Yes
No
Merocel (Medtronic)
Polyvinyl alcohol
Synthetic
No
Yes13
Salman stent (Boston Medical)
Silicone
Synthetic
No
No
Gelfilm (Pharmacia and Upjohn)
Gelatin, collagen
Animal
Yes
Gelfoam (Pharmacia and Upjohn
Gelatin, collagen
Animal
Floseal (Baxter International)
Gelatin/thrombin
Surgiflo (Ethicon) Surgicel (Ethicon) MeroGel (Medtronic)
Abbreviations: CMC, carboxymethylcellulose; FESS, functional endoscopic sinus surgery; MPH, microporous polysaccharide hemospheres; NA, not applicable; RCT, randomized clinical trial. a
Hemostasis, pain
Synechiae Synechiae, hemostasis, granulation, edema, crusting, infection
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Synechiae,c pain
NA
Synechiae,c hemostasis, congestion, infection
Congestion
NA
Synechiae
NA
NA Synechiae, congestion, edema, pain, infection, discharge NA
b
Outcome measure improved with middle meatal dressing compared with placebo.
c
Conflicting results among studies.
Human trial in patients with chronic rhinosinusitis undergoing FESS with clinical end points.
Pro
subjective assessment with only fair interrater reliability.4 Perhaps the best evidence for this problem are the numerous techniques proposed to prevent its occurrence, including creating controlled synechiae between the turbinate and septum and techniques to suture the turbinate in a medial position. Finally, postoperative bleeding, both immediate and delayed, represents an undesired complication. Epistaxis severe enough to require clinical attention has been estimated to occur in 1% to 6% of cases across studies.3
Need for Dressings
Outcomes
Middle meatal dressings represent an attempt to address complications encountered with some degree of regularity following FESS. Synechiae formation in the middle meatus is estimated to occur in 0% to 40% of cases, with most authors reporting rates greater than 15%.2 It remains a commonly held belief that scarring negatively impacts outcomes of surgery and predicts need for future revision procedures.3 Lateralization of the middle turbinate is another undesired outcome of surgery because it may increase synechiae formation and limits access into the middle meatus for endoscopic visualization and topical delivery of medications. Precise rates of turbinate lateralization are difficult to estimate because turbinate position remains a
Lee and Grewal5 recently performed a systematic review with metaanalysis of randomized clinical trials (RCTs) evaluating middle meatal dressings used after FESS in adults with CRS. A total of 23 studies were identified, but 15 of the studies compared one type of dressing to another, without an arm for no intervention. This included several studies evaluating the Propel implant (Intersect ENT Inc). Although these studies sometimes showed superiority of one dressing over another, they provided little insight as to whether the superior dressing would be better than no dressing at all. Eight studies compared a specific dressing to no dressing and described at least 1 clinical outcome. Studies were published from 2001 to 2010 and
ers, stents, or implants. Searches were repeated including known materials as key words. References of identified studies were scanned as were prior reviews on the subject. Only controlled clinical studies of human participants with CRS that compared a given dressing to no dressing were included. Those studies comparing one dressing to another dressing were assessed, but superiority of one over another was not equated with superiority to no intervention.
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Synechiae
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Post-FESS Middle Meatal Dressings
Clinical Challenges in Otolaryngology Clinical Review & Education
included absorbable (Sepragel Sinus [Genzyme Biosurgery],6,7 Merogel [Medtronic],8 Floseal [Baxter International],9 carboxymethylcellulose (CMC) net/gel,10,11 Chitosan gel [Medtronic]12) and nonabsorbable (Merocel [Medtronic]13) materials. Additional RCTs not included in their review were identified that evaluated microporous polysaccharide hemospheres (MPH),14,15 Seprapack [Genzyme Biosurgery],16 Gelfilm [Pharmacia and Upjohn],17 and Gelfoam [Pharmacia and Upjohn]18 dressings. When synechiae prevention was evaluated via meta-analysis, the use of dressings was found to result in a nonsignificant trend toward less synechiae formation, with a summary risk ratio (RR) equal to 0.4 (95% CI, 0.14-1.12). As might be expected, there was significant heterogeneity among types of dressings. The single study evaluating the nonabsorbable dressing Merocel found a significant improvement in synechiae (RR, 0.21 [95% CI, 0.10-0.44]).13 Subgroup analysis pooling data from the 3 studies evaluating absorbable dressings failed to show a significant reduction (P = .44).8,10,12 Of the absorbable dressings, Chitosan gel resulted in less synechiae formation than no dressing (RR, 0.17 [95% CI, 0.04-0.69]).12 Studies evaluating hyaluronic acid dressings had mixed results, with one study demonstrating a reduction in synechiae scores7 and the other studies showing no difference compared with controls.6,8,16 None of the studies showed long-term (>1 month) improvements in mucosal appearance, including crusting, granulation tissue, or edema and/or polyps.6-18 Three RCTs have evaluated the ability of absorbable dressings to improve intraoperative hemostasis at the conclusion of surgery.6,9,12 Chitosan gel resulted in hemostasis at an average of 2 minutes vs 10 minutes for no dressing12 and Floseal demonstrated a similar effect, resulting in cessation of bleeding after 16 minutes compared with 31 minutes in controls.9 In contrast, Sepragel Sinus failed to show a difference in immediate hemostasis.6 Several studies that looked at delayed postoperative bleeding in the weeks following FESS failed to show a significant difference for Merocel, CMC, MeroGel, and Floseal dressings.8,9,11,13 Visual analog scale scores for bleeding on postoperative day 1 were reduced by MPH compared with control (22.5 vs 39; P < .001). However, the clinical relevance of 16.5 points on this 0-100 scale is uncertain (a score of 50 meant bleeding requiring occasional change of drip pad), and no other time points showed significant findings.15 Sinus-specific symptoms and QOL are arguably the gold standard outcome metrics for FESS and FESS dressings. Unfortunately, none of the reviewed controlled clinical trials evaluating middle meatal dressings reported long-term QOL or symptom-specific data. Several studies have evaluated short-term pain and congestion, with conflicting results. No difference in pain scores was found between patients with and without Merocel. Floseal dressing resulted in less pain compared with sides without dressing in the week following surgery.9 Similarly, Sepragel Sinus resulted in less pain in week 2 only but no difference in congestion at any time.7 Seprapack resulted in less congestion at 8 weeks compared with no treatment.16
Con Need for Dressings
It remains a commonly held belief that middle meatal synechiae and/or middle turbinate lateralization can lead to poor outcomes and predict the need for revision surgery. This teaching extends back to jamaotolaryngology.com
the pioneers of FESS and is commonly cited as a reason to use dressings to prevent the middle turbinate from scarring to the lateral nasal wall.19 In a prospective study, middle turbinate lateralization was found in 78% of patients undergoing revision sinus surgery—the most common anatomic finding.20 However, association is not causation, and there remains little direct proof that middle meatal synechiae alone leads to worse outcomes. In some instances the middle turbinate may densely adhere to the lateral nasal wall and orbit, obstructing the frontal recess and/or maxillary sinus. However, in many (if not most) instances, synechiae may not obstruct the sinus ostia or impair nasal airflow, and in these cases they may be of little clinical relevance. In a recent prospective clinical trial of 100 patients undergoing FESS, there was no association between the presence of synechiae and patient symptoms or radiographic findings after an average of 10 years’ follow-up.21 As described above, some middle meatal dressings have been shown to improve immediate hemostasis at the conclusion of FESS. However, significant bleeding is not encountered in most sinus surgeries. A recent review of a national database of 62 000 FESS procedures found significant hemorrhage to occur in less than 1% of cases.22 Orlandi and Lanza23 reported a retrospective case series of 165 patients undergoing FESS, of which none had significant postoperative bleeding. Of the last 91 procedures, 95% had no middle meatal dressing placed at the conclusion of surgery. This study suggests that perioperative systemic steroids, topical vasoconstrictors, localized injections, and meticulous technique may provide adequate short- and long-term hemostasis in the majority of instances. Outcomes
As described above, level 1 evidence exists that some middle meatal dressings reduce synechiae formation (Merocel and Chitosan), and others may improve perioperative hemostasis (Chitosan, Floseal, and MPH). However, none of these studies provide data demonstrating improvement in long-term symptoms, QOL, postoperative hemorrhage, infection rates, or need for revision surgery. It should also be kept in mind that perioperative adjunctive measures were not standardized among studies and oftentimes were not performed. Relevant measures that might reduce bleeding (preoperative steroids, topical vasoconstrictors) and synechiae formation (suturing techniques, saline irrigations, debridements, topical steroids) might further obviate the need for middle meatal dressings.
Bottom Line No currently available material possesses all of the characteristics of the ideal middle meatal dressing, nor have any been shown to improve long-term outcomes after surgery compared with no intervention. Based on available evidence, the placement of a middle meatal dressing appears unnecessary after most FESS procedures. In specific instances where bleeding persists at the conclusion of surgery, dressings that excel in hemostasis can be considered, such as Chitosan, Floseal, or MPH. If there is concern that the middle turbinate is unstable and/or has been overly traumatized, dressings that minimize synechiae formation may be considered, including Merocel and Chitosan. With the past as a guide, the future will surely see the introduction of novel middle meatal dressings, supplementing those already available. Surgeons should remain prudent regarding their use and continue to demand placebo-controlled evidence that dressings improve clinically meaningful outcomes after FESS.
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Clinical Review & Education Clinical Challenges in Otolaryngology
ARTICLE INFORMATION Author Affiliations: Division of Rhinology and Sinus Surgery, Department of Otolaryngology–Head and Neck Surgery, Medical University of South Carolina, Charleston. Corresponding Author: Rodney J. Schlosser, MD, Division of Rhinology and Sinus Surgery, Department of Otolaryngology–Head and Neck Surgery, Medical University of South Carolina, 171 Ashley Ave, Charleston, SC 29425 ([email protected]). Section Editor: Marion Boyd Gillespie, MD, MSc. Submitted for Publication: July 20, 2012; final revision received March 27, 2013; accepted September 15, 2013. Published Online: October 31, 2013. doi:10.1001/jamaoto.2013.5439. Author Contributions: Drs Soler and Schlosser had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Both authors. Acquisition of data: Soler. Analysis and interpretation of data: Soler. Drafting of the manuscript: Both authors. Critical revision of the manuscript for important intellectual content: Both authors. Statistical analysis: Soler. Study supervision: Schlosser. Conflict of Interest Disclosures: None reported. REFERENCES 1. Stevens RW. Nasal packing; the rubber pneumatic pack. AMA Arch Otolaryngol. 1951;54(2):191-194. 2. Weitzel EK, Wormald PJ. A scientific review of middle meatal packing/stents. Am J Rhinol. 2008;22(3):302-307. 3. Valentine R, Wormald PJ. Nasal dressings after endoscopic sinus surgery: what and why? Curr Opin Otolaryngol Head Neck Surg. 2010;18(1):44-48. 4. McCoul ED, Smith TL, Mace JC, et al. Interrater agreement of nasal endoscopy in patients with a
Clinical Review & Education
prior history of endoscopic sinus surgery. Int Forum Allergy Rhinol. 2012;2(6):453-459. 5. Lee JM, Grewal A. Middle meatal spacers for the prevention of synechiae following endoscopic sinus surgery: a systematic review and meta-analysis of randomized controlled trials. Int Forum Allergy Rhinol. 2012;2(6):477-486. 6. Frenkiel S, Desrosiers MY, Nachtigal D. Use of hylan B gel as a wound dressing after endoscopic sinus surgery. J Otolaryngol. 2002;31(Suppl 1): S41-S44. 7. Kimmelman CP, Edelstein DR, Cheng HJ. Sepragel sinus (hylan B) as a postsurgical dressing for endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2001;125(6):603-608. 8. Wormald PJ, Boustred RN, Le T, Hawke L, Sacks R. A prospective single-blind randomized controlled study of use of hyaluronic acid nasal packs in patients after endoscopic sinus surgery. Am J Rhinol. 2006;20(1):7-10. 9. Jameson M, Gross CW, Kountakis SE. FloSeal use in endoscopic sinus surgery: effect on postoperative bleeding and synechiae formation. Am J Otolaryngol. 2006;27(2):86-90. 10. Kastl KG, Betz CS, Siedek V, Leunig A. Control of bleeding following functional endoscopic sinus surgery using carboxy-methylated cellulose packing. Eur Arch Otorhinolaryngol. 2009;266(8):1239-1243. 11. Kastl KG, Betz CS, Siedek V, Leunig A. Effect of carboxymethylcellulose nasal packing on wound healing after functional endoscopic sinus surgery. Am J Rhinol Allergy. 2009;23(1):80-84. 12. Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010;24(1):70-75. 13. Bugten V, Nordgård S, Skogvoll E, Steinsvåg S. Effects of nonabsorbable packing in middle meatus after sinus surgery. Laryngoscope. 2006;116(1):83-88.
increase synechiae after sinus surgery: randomized controlled study. Am J Rhinol Allergy. 2011;25(4): 268-271. 15. Antisdel JL, West-Denning JL, Sindwani R. Effect of microporous polysaccharide hemospheres (MPH) on bleeding after endoscopic sinus surgery: randomized controlled study. Otolaryngol Head Neck Surg. 2009;141(3):353-357. 16. Woodworth BA, Chandra RK, Hoy MJ, Lee FS, Schlosser RJ, Gillespie MB. Randomized controlled trial of hyaluronic acid/carboxymethylcellulose dressing after endoscopic sinus surgery. ORL J Otorhinolaryngol Relat Spec. 2010;72(2):101-105. 17. Tom LW, Palasti S, Potsic WP, Handler SD, Wetmore RF. The effects of gelatin film stents in the middle meatus. Am J Rhinol. 1997;11(3):229-232. 18. Wee JH, Lee CH, Rhee CS, Kim JW. Comparison between Gelfoam packing and no packing after endoscopic sinus surgery in the same patients. Eur Arch Otorhinolaryngol. 2012;269(3):897-903. 19. Metson RB, Platt MP. Complications of endoscopic sinus surgery: Prevention and management. In: Kennedy DW, Hwang PH, eds. Rhinology: Diseases of the Nose, Sinuses, and Skull Base. New York, NY: Thieme; 2012. 20. Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004;25(6):418-422. 21. Mus L, Hermans R, Jorissen M. Long-term effects of cutting versus non-cutting instruments in FESS. Rhinology. 2012;50(1):56-66. 22. Ramakrishnan VR, Kingdom TT, Nayak JV, Hwang PH, Orlandi RR. Nationwide incidence of major complications in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2012;2(1):34-39. 23. Orlandi RR, Lanza DC. Is nasal packing necessary following endoscopic sinus surgery? Laryngoscope. 2004;114(9):1541-1544.
14. Antisdel JL, Matijasec JL, Ting JY, Sindwani R. Microporous polysaccharide hemospheres do not
Invited Commentary CLINICAL CHALLENGES IN OTOLARYNGOLOGY
The Role of Middle Meatal Dressings in Endoscopic Sinus Surgery Andrew P. Lane, MD
Outcomes in endoscopic sinus surgery are determined by an interplay of numerous factors, some intrinsic to the patient and others related to management decisions and actions taken by the surgeon before, during, and after surgery. Related article page 1351 There is great variety in the specific perioperative medical regimens and surgical techniques that sinus surgeons employ. This is in part necessitated by the heterogeneity of sinus disease but mainly reflects individual practice prefer1354
ences derived from training, experience, and interpretation of expert recommendations. A relatively small number of these interventions have a strong evidence basis in randomized clinical trials. In formulating treatment plans, we all strive to use our informed clinical judgment to achieve the best results for our patients. One of the numerous decisions faced along the way in the surgical management of sinusitis is the placement of a postsurgical middle meatal dressing. The article by Soler and Schlosser 1 in this issue cogently reviews the current evidence regarding the pros and cons of
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