SPINE Volume 39, Number 8, pp E481-E485 ©2014, Lippincott Williams & Wilkins
RANDOMIZED TRIAL
Comparison of 2 Methods of Incision Closure in Patients With Adolescent Idiopathic Scoliosis Undergoing Posterior Spinal Fusion Surgery Leilei Xu, PhD, Feng Zhu, MD, Zezhang Zhu, MD, Zhen Liu, MD, Xu Sun, MD, Jun Qiao, PhD, Saihu Mao, MD, and Yong Qiu, MD
Study Design. A prospective, randomized, and controlled clinical trial. Objective. To compare surgical zipper with subcuticular Monocryl sutures in terms of incision closure time, cosmetic results, and the complication rate in patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion (PSF) surgery. Summary of Background Data. In previous literatures, the application of surgical zipper to incision closure has been reported to be associated with a favorable outcome. However, in the PSF surgery of patients with AIS, the use of surgical zipper has not been described. Methods. Ninety female patients with AIS undergoing PSF were assigned randomly to 2 incision closure groups either using surgical zipper or using the 4-0 absorbable subcuticular suture. The incision outcome was evaluated with the Hollander Incision Evaluation Score at 7 days, 2 weeks, 6 months, and 1 year after surgery, respectively. Besides, a visual analogue scale was allocated to each patient to rate the cosmetic result of the incision. The 2 groups were compared to determine the differences in terms of incision closure time, the complication rate, and cosmetic results. Results. The incision closure using surgical zipper consumed significantly less time than that using subcuticular suture (45.3 vs. 540.5 s, P < 0.001). As for the cosmetic results, no significant differences of Hollander Incision Evaluation Score scores between the 2 suturing groups were found. Besides, patients’ satisfaction with cosmetic outcome on a linear visual analogue scale also revealed similar results between the 2 groups. As for postoperative
From The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China. Acknowledgment date: July 26, 2013. Revision date: November 27, 2013. Acceptance date: January 9, 2014. The manuscript submitted does not contain information about medical device(s)/drug(s). The National Public Health Benefit Research Foundation, China (grant no. 201002018) funds were received in support of this work. No relevant financial activities outside the submitted work. Address correspondence and reprint requests to Yong Qiu, MD, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Zhongshan Rd 321, Nanjing 210008, China; E-mail: [email protected] DOI: 10.1097/BRS.0000000000000223 Spine
complications, we found 1 case of mild blister due to allergy to the tape of the dressings and 2 cases of incisional pain in the Monocryl suture group. Conclusion. The application of surgical zipper in PSF surgery is a safe and effective method. The ease and the speed of application make surgical zipper an attractive option for incision closure in patients with AIS undergoing PSF. Key words: incision closure, surgical zipper, cosmetic outcome, scoliosis, randomized trial, deformity. Level of Evidence: 4 Spine 2014;39:E481–E485
A
s a primary surgical modality for patients with adolescent idiopathic scoliosis (AIS),1,2 posterior spinal fusion (PSF) routinely starts with a long skin incision in the back. Ideally, the incision closure after PSF should be safe and effective in terms of time to heal and a favorable appearance of the scar. To date, different types of incision closure techniques have been applied to clinical practice, including synthetic sutures, absorbable sutures, tapes, and adhesive compounds.3–5 Recently, a new closure technique named surgical zipper is being widely used to facilitate the incision healing.6–8 This noninvasive closure system allows a homogeneous distribution of stress bilaterally across the entire incision region, thus facilitating a natural healing process of the incision.6–8 Other advantages of surgical zipper include ease of use, painless application, rapid closure, and the avoidance of needle stick injuries.9,10 In previous literatures, the surgical zipper has been reported to produce a favorable outcome for incision closure in a wide spectrum of surgical areas including oncology surgery, orthopedic trauma surgery, and urological surgery.7–9 As for correction surgery of patients with AIS, however, the use of surgical zipper has never been described. To evaluate the effect of surgical zipper on the incision closure and healing in patients with AIS undergoing PSF, a randomized and controlled clinical study was prospectively performed. This study was designed to compare surgical zipper with subcuticular Monocryl sutures in terms of incision closure time, cosmetic results, and related complications. www.spinejournal.com
E481
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. SPINE130902_LR E481
21/03/14 9:53 AM
RANDOMIZED TRIAL
Incision Closure of Patients With AIS • Xu et al
MATERIALS AND METHODS The study was carried out under the approval of the Medical Ethical Commission of the hospital. Considering that patients with different curve patterns could have remarkable differences in terms of fusion level numbers, incision length, and self-evaluation for the incision, we prospectively enrolled 90 female patients with AIS with main thoracic curve who underwent selective PSF surgical procedures from July 2011 to June 2012. All patients were informed of the study and provided their written consents. Data on patients’ general information and medical history were recorded. Patients with insulin-dependent diabetes mellitus, history of posterior spinal surgery, personal or family history of keloid or hypertrophic scar formation, and known allergy to surgical zipper were excluded from the study. The patients were allocated alternatively into 2 incision closure groups: one using surgical zipper (Surgizip; MediTech Healthcare Inc., Singapore); the other using the 4-0 absorbable subcuticular suture (Monocryl). As shown in Figure 1A, the Surgizip is a combination of microporous polyester and a zipper that is coated with acrylate adhesive. Figure 1B, C illustrates the application of the Surgizip. When applying the Surgizip to the incision closure, surgeons should note that the Surgizip must be 2 to 3 cm longer than the incision. Besides, a distance of 0.5 cm should be maintained between the edge of the incision and the zipper teeth. And it is highly recommended to align the edge of the incision with tweezers at the same time when the rear loop was pulled gently to close the zipper. Enclosed in sealed identical opaque envelopes, allocation of patients remained classified until one attending surgeon (Z.Z.) and one senior resident (S.X.) carried out the incision closure with the drains consistently used for both groups. Before incision closure of both groups, the underlying fascia was closed in a standard manner using continuous polydioxanone sutures, and interrupted 3-0 Vicryl (Monocryl, Johnson & Johnson Inc, New Brunswick, NJ) was used to close the subcutaneous tissue to reduce skin tension and align the incision edges. The time consumed for incision closure was recorded in seconds, and the length of the incision was recorded in centimeters. The timer started when either the surgical zipper or the 4-0 Monocryl suture was handed to the surgeons. The timer was stopped when the surgical zipper was completely closed or when the incision was completely closed with continuous subcuticular suture. The sutured incisions were covered by the standard identical dressings, which were changed on the second day after operation. As shown in Figure 1D, the surgical zipper was removed on the seventh day after operation. Patients were discharged from hospital when the incisions were dry and they were able to move independently. Patients were proposed to visit the clinic at 6 months and 1 year after operation, respectively. At the discharge of the patient, complications related to incision closure were evaluated. Specifically, incisional pain was recorded if the patient complained of intolerable postsurgical pain along the incision despite the administration of analgesics immediately after surgery. The incision outcome was evaluated at 7 days, 2 weeks, 6 months, and 1 year after surgery by the same assessor (X.L.). E482
Figure 1. The application of the Surgizip to incision closure of patients with AIS undergoing posterior spinal fusion surgical procedures. A, The appearance of the Surgizip before application. B, Attached to the incision. C, Gently pulled to close the incision. D, Removal of the Surgizip on the seventh day after operation. AIS indicates adolescent idiopathic scoliosis.
Using the Hollander Incision Evaluation Score,11 the assessor graded scars for cosmesis in terms of step-off borders, contour irregularities, scar width, edge inversion, excessive inflammation, and overall cosmetic appearance. For each patient at the follow-up visit, a visual analogue scale with a score ranging from 0 to 10 was assigned to the patient to rate the cosmetic result of the incision, with a score of 10 reflecting the optimal cosmetic outcome. Specifically, patients managed to rate their incision through a high-resolution photo of their back taken by the assessor (X.L.). With a complete collection of the data, the 2 groups were then compared to determine the differences in terms of incision closure time, incision length, cosmetic results, and related complications. Specifically, intragroup comparisons concerning differences between cosmetic results at 6-month follow-up and at 1-year follow-up were carried out for both groups. The software Statistical Package for the Social Sciences (SPSS, version 13.0; SPSS Inc, Chicago, IL) was used for statistical analyses. Descriptive results were expressed as the mean value ±1 standard deviation. Student t test was used for comparison of continuous numeric data, and the χ2 test was used for categorical data. A P value of 0.05 was considered to be statistically significant.
RESULTS The baseline characteristics of the patients are shown in Table 1. The mean age of the whole cohort was 13.3 ± 2.3 years old. The average number of levels fused was 9.8 ± 1.3. The length of incision was in the range from 29.2 cm to 34.2 cm, averaged 31.5 ± 2.5 cm. The mean curve magnitude was 52.3° ± 8.7°, ranging from 45° to 70°. Incision closures were successfully completed in the all 90 patients, of whom 45 incisions were closed with surgical zipper and the other 45 were closed with 4-0 subcuticular Monocryl sutures. The incisions
www.spinejournal.com
April 2014
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. SPINE130902_LR E482
21/03/14 9:53 AM
RANDOMIZED TRIAL
Incision Closure of Patients With AIS • Xu et al
TABLE 1. Comparison of the Patients’ Baseline Characteristics Between the 2 Suturing Groups Group
N
Age (yr)
BMI (kg/m2)
Number of Levels Fused
Length of Incision (cm)
Time for Closure (s)
Surgical zipper
45
13.2 ± 1.6
17.8 ± 3.5
9.6 ± 1.6
31.2 ± 3.2
45.3 ± 5.3
4-0 Monocryl
45
13.5 ± 2.1
17.2 ± 4.2
9.9 ± 1.2
32.2 ± 2.2
540.5 ± 23.8
0.84
0.72
0.55
0.67
RANDOMIZED TRIAL
Comparison of 2 Methods of Incision Closure in Patients With Adolescent Idiopathic Scoliosis Undergoing Posterior Spinal Fusion Surgery Leilei Xu, PhD, Feng Zhu, MD, Zezhang Zhu, MD, Zhen Liu, MD, Xu Sun, MD, Jun Qiao, PhD, Saihu Mao, MD, and Yong Qiu, MD
Study Design. A prospective, randomized, and controlled clinical trial. Objective. To compare surgical zipper with subcuticular Monocryl sutures in terms of incision closure time, cosmetic results, and the complication rate in patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion (PSF) surgery. Summary of Background Data. In previous literatures, the application of surgical zipper to incision closure has been reported to be associated with a favorable outcome. However, in the PSF surgery of patients with AIS, the use of surgical zipper has not been described. Methods. Ninety female patients with AIS undergoing PSF were assigned randomly to 2 incision closure groups either using surgical zipper or using the 4-0 absorbable subcuticular suture. The incision outcome was evaluated with the Hollander Incision Evaluation Score at 7 days, 2 weeks, 6 months, and 1 year after surgery, respectively. Besides, a visual analogue scale was allocated to each patient to rate the cosmetic result of the incision. The 2 groups were compared to determine the differences in terms of incision closure time, the complication rate, and cosmetic results. Results. The incision closure using surgical zipper consumed significantly less time than that using subcuticular suture (45.3 vs. 540.5 s, P < 0.001). As for the cosmetic results, no significant differences of Hollander Incision Evaluation Score scores between the 2 suturing groups were found. Besides, patients’ satisfaction with cosmetic outcome on a linear visual analogue scale also revealed similar results between the 2 groups. As for postoperative
From The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China. Acknowledgment date: July 26, 2013. Revision date: November 27, 2013. Acceptance date: January 9, 2014. The manuscript submitted does not contain information about medical device(s)/drug(s). The National Public Health Benefit Research Foundation, China (grant no. 201002018) funds were received in support of this work. No relevant financial activities outside the submitted work. Address correspondence and reprint requests to Yong Qiu, MD, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Zhongshan Rd 321, Nanjing 210008, China; E-mail: [email protected] DOI: 10.1097/BRS.0000000000000223 Spine
complications, we found 1 case of mild blister due to allergy to the tape of the dressings and 2 cases of incisional pain in the Monocryl suture group. Conclusion. The application of surgical zipper in PSF surgery is a safe and effective method. The ease and the speed of application make surgical zipper an attractive option for incision closure in patients with AIS undergoing PSF. Key words: incision closure, surgical zipper, cosmetic outcome, scoliosis, randomized trial, deformity. Level of Evidence: 4 Spine 2014;39:E481–E485
A
s a primary surgical modality for patients with adolescent idiopathic scoliosis (AIS),1,2 posterior spinal fusion (PSF) routinely starts with a long skin incision in the back. Ideally, the incision closure after PSF should be safe and effective in terms of time to heal and a favorable appearance of the scar. To date, different types of incision closure techniques have been applied to clinical practice, including synthetic sutures, absorbable sutures, tapes, and adhesive compounds.3–5 Recently, a new closure technique named surgical zipper is being widely used to facilitate the incision healing.6–8 This noninvasive closure system allows a homogeneous distribution of stress bilaterally across the entire incision region, thus facilitating a natural healing process of the incision.6–8 Other advantages of surgical zipper include ease of use, painless application, rapid closure, and the avoidance of needle stick injuries.9,10 In previous literatures, the surgical zipper has been reported to produce a favorable outcome for incision closure in a wide spectrum of surgical areas including oncology surgery, orthopedic trauma surgery, and urological surgery.7–9 As for correction surgery of patients with AIS, however, the use of surgical zipper has never been described. To evaluate the effect of surgical zipper on the incision closure and healing in patients with AIS undergoing PSF, a randomized and controlled clinical study was prospectively performed. This study was designed to compare surgical zipper with subcuticular Monocryl sutures in terms of incision closure time, cosmetic results, and related complications. www.spinejournal.com
E481
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. SPINE130902_LR E481
21/03/14 9:53 AM
RANDOMIZED TRIAL
Incision Closure of Patients With AIS • Xu et al
MATERIALS AND METHODS The study was carried out under the approval of the Medical Ethical Commission of the hospital. Considering that patients with different curve patterns could have remarkable differences in terms of fusion level numbers, incision length, and self-evaluation for the incision, we prospectively enrolled 90 female patients with AIS with main thoracic curve who underwent selective PSF surgical procedures from July 2011 to June 2012. All patients were informed of the study and provided their written consents. Data on patients’ general information and medical history were recorded. Patients with insulin-dependent diabetes mellitus, history of posterior spinal surgery, personal or family history of keloid or hypertrophic scar formation, and known allergy to surgical zipper were excluded from the study. The patients were allocated alternatively into 2 incision closure groups: one using surgical zipper (Surgizip; MediTech Healthcare Inc., Singapore); the other using the 4-0 absorbable subcuticular suture (Monocryl). As shown in Figure 1A, the Surgizip is a combination of microporous polyester and a zipper that is coated with acrylate adhesive. Figure 1B, C illustrates the application of the Surgizip. When applying the Surgizip to the incision closure, surgeons should note that the Surgizip must be 2 to 3 cm longer than the incision. Besides, a distance of 0.5 cm should be maintained between the edge of the incision and the zipper teeth. And it is highly recommended to align the edge of the incision with tweezers at the same time when the rear loop was pulled gently to close the zipper. Enclosed in sealed identical opaque envelopes, allocation of patients remained classified until one attending surgeon (Z.Z.) and one senior resident (S.X.) carried out the incision closure with the drains consistently used for both groups. Before incision closure of both groups, the underlying fascia was closed in a standard manner using continuous polydioxanone sutures, and interrupted 3-0 Vicryl (Monocryl, Johnson & Johnson Inc, New Brunswick, NJ) was used to close the subcutaneous tissue to reduce skin tension and align the incision edges. The time consumed for incision closure was recorded in seconds, and the length of the incision was recorded in centimeters. The timer started when either the surgical zipper or the 4-0 Monocryl suture was handed to the surgeons. The timer was stopped when the surgical zipper was completely closed or when the incision was completely closed with continuous subcuticular suture. The sutured incisions were covered by the standard identical dressings, which were changed on the second day after operation. As shown in Figure 1D, the surgical zipper was removed on the seventh day after operation. Patients were discharged from hospital when the incisions were dry and they were able to move independently. Patients were proposed to visit the clinic at 6 months and 1 year after operation, respectively. At the discharge of the patient, complications related to incision closure were evaluated. Specifically, incisional pain was recorded if the patient complained of intolerable postsurgical pain along the incision despite the administration of analgesics immediately after surgery. The incision outcome was evaluated at 7 days, 2 weeks, 6 months, and 1 year after surgery by the same assessor (X.L.). E482
Figure 1. The application of the Surgizip to incision closure of patients with AIS undergoing posterior spinal fusion surgical procedures. A, The appearance of the Surgizip before application. B, Attached to the incision. C, Gently pulled to close the incision. D, Removal of the Surgizip on the seventh day after operation. AIS indicates adolescent idiopathic scoliosis.
Using the Hollander Incision Evaluation Score,11 the assessor graded scars for cosmesis in terms of step-off borders, contour irregularities, scar width, edge inversion, excessive inflammation, and overall cosmetic appearance. For each patient at the follow-up visit, a visual analogue scale with a score ranging from 0 to 10 was assigned to the patient to rate the cosmetic result of the incision, with a score of 10 reflecting the optimal cosmetic outcome. Specifically, patients managed to rate their incision through a high-resolution photo of their back taken by the assessor (X.L.). With a complete collection of the data, the 2 groups were then compared to determine the differences in terms of incision closure time, incision length, cosmetic results, and related complications. Specifically, intragroup comparisons concerning differences between cosmetic results at 6-month follow-up and at 1-year follow-up were carried out for both groups. The software Statistical Package for the Social Sciences (SPSS, version 13.0; SPSS Inc, Chicago, IL) was used for statistical analyses. Descriptive results were expressed as the mean value ±1 standard deviation. Student t test was used for comparison of continuous numeric data, and the χ2 test was used for categorical data. A P value of 0.05 was considered to be statistically significant.
RESULTS The baseline characteristics of the patients are shown in Table 1. The mean age of the whole cohort was 13.3 ± 2.3 years old. The average number of levels fused was 9.8 ± 1.3. The length of incision was in the range from 29.2 cm to 34.2 cm, averaged 31.5 ± 2.5 cm. The mean curve magnitude was 52.3° ± 8.7°, ranging from 45° to 70°. Incision closures were successfully completed in the all 90 patients, of whom 45 incisions were closed with surgical zipper and the other 45 were closed with 4-0 subcuticular Monocryl sutures. The incisions
www.spinejournal.com
April 2014
Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. SPINE130902_LR E482
21/03/14 9:53 AM
RANDOMIZED TRIAL
Incision Closure of Patients With AIS • Xu et al
TABLE 1. Comparison of the Patients’ Baseline Characteristics Between the 2 Suturing Groups Group
N
Age (yr)
BMI (kg/m2)
Number of Levels Fused
Length of Incision (cm)
Time for Closure (s)
Surgical zipper
45
13.2 ± 1.6
17.8 ± 3.5
9.6 ± 1.6
31.2 ± 3.2
45.3 ± 5.3
4-0 Monocryl
45
13.5 ± 2.1
17.2 ± 4.2
9.9 ± 1.2
32.2 ± 2.2
540.5 ± 23.8
0.84
0.72
0.55
0.67
