The Laryngoscope C 2014 The American Laryngological, V
Rhinological and Otological Society, Inc.
Do Topical Products Reduce Postincision Scars? David B. Hom, MD; Katherine A. Hom, MS, BS BACKGROUND A common question asked by patients who are healing from a surgical incision is, “What is the best product to use to minimize a scar?” Commercially, the many topical products on the market make it difficult to decide what is the best product to recommend. Each product claims to have its advantages in reducing scarring with its combination of ingredients. Often, many of these products are not regulated by the US Food and Drug Administration, because over the counter (OTC) products are not classified as a drug or device. Thus, the chosen topical antiscar product is frequently based on anecdotal evidence, physician bias, or patient preference. Silicone gel, paper tape, cyanoacrylates, onion extract, and vitamin E are commonly used topical products for postincision scars. This article reviews the evidence surrounding the use of these topical products to reduce postincision scarring (Table I).
LITERATURE REVIEW To evaluate the scar benefits of silicone gel, Giorgi et al.1 conducted a randomized, controlled trial in 110 patients comparing silicone gel to the control group receiving zinc oxide cream. The treatment group of 65 patients applied silicone gel twice a day for 60 days after suture removal. Forty-five patients applied zinc oxide cream as the control. The same dermatologists examined the scars over 8 months. Twenty-seven percent of patients in the treatment group had pathological scarring compared to 55% in the control group. Keloid scars did not develop in the treatment group, but were present in 11% of the control group. Hypertrophic scars formed in 9% of the silicone gel-treated group compared to 22% of the control group. Silicone gel was effective in improv-
From the Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery (D.B.H.), University of Cincinnati College of Medicine, Cincinnati, Ohio; and the University of California School of Medicine at Irvine (K.A.H.), Irvine, California, U.S.A. The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to David B. Hom, MD, Director, Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267-0528. E-mail: [email protected] DOI: 10.1002/lary.24768
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ing the scar appearance by making it softer, smoother, and flatter as well as minimizing scar tissue thickness. Atkinson et al.2 performed a scar comparison study of paper tape application to untapped incisions in a randomized, controlled trial of 70 patients. Specifically, the hypertrophic scar characteristics of cesarean section incisions were measured using international scar classification guidelines and utilizing ultrasound to record interdermal volume. At weeks 6 and 12 and at 6 months, paper tape statistically decreased scar volume compared to controls. After the patients completed the 12-weekperiod therapy, 0% of the treatment group developed hypertrophic scars compared to 41% of the control group. This study concluded that the odds of a hypertrophic scar was 13.6 times greater in patients who received no paper tape than in those who applied paper tape. The authors recommend leaving the tape on for at least 12 weeks after the sutures are removed . Limitations of this study were that only 39 out of 70 enrolled patients completed the study, and patients with a keloid history were excluded. To compare the effectiveness of topical cyanoacrylate to silicone gel in preventing pathological scarring, Scuderi et al.3 conducted a prospective, multicenter, cross-over phase 2 study in 85 patients. After bilateral mastoplasty, cyanoacrylate was applied to one side of the scar every 3 to 5 days, twice a day, for 3 months, and silicone gel was applied in a similar fashion. Patients and three blinded physicians rated the scar characteristics using a 10-point visual analog scale before treatment and then 12 months after treatment. Photos were taken after suture removal at 1 month and 12 months later. Objective evaluations with a magnification lens, caliper, and optical profilometry measured size, surface texture, and elevation of the scars. Both silicone gel and cyanoacrylate application showed improved postsurgical scar quality, with cyanoacrylates having less scar widening than silicone gel. The authors suggest that the beneficial properties of topical cyanoacrylate are its occlusion action, ability to resist traction, and protective barrier to infection. The effectiveness of topical onion extract-based gel compared to a petrolatum-based ointment was conducted by Chung et al.4 in a prospective, randomized, doubleblind study of 24 patients. Each scar had one-half receiving onion extract gel and the other half using petrolatum ointment at the time of suture removal. Patients applied the ointments three times daily for 8 weeks. Hom and Hom: Reducing Scars With Topical Products
TABLE I. Evidence Surrounding the Use of These Topical Products. Scar Product
Study
Incision Site
Application Frequency
Control
Length of Study
Scar Results
Level of Evidence
Silicone gel
Giorgi et al. 2009
Multiple skin sites on body
2 3 per day for 60 days
Zinc oxide cream
8 months
Reduced hypertrophic scar and keloids
1
Paper tape (Micropore) Cyanoacrylate (Wipescar) Onion extract gel (Mederma)
Atkinson et al. 2005
Abdomen skin
For 12 weeks
No tape
6 months
1
Scuderi et al. 2011
Breast skin Head, trunk, extremity skin
Silicone gel (Dermatix) Petrolatum ointment
12 months
Chung et al. 2006
Every 3–5 days for 3 months 3 3 per day for 8 weeks
12 weeks
Reduced hypertrophic scar Both products improved final scar outcome No improvement
1
Khoo et al. 2011
Multiple skin sites on body
2 3 per day for 6 weeks
Placebo cream
16 weeks
No improvement
1
Vitamin E (5% tocotrienol)
Using a visual log scale at 2, 8, and 12 weeks, the scar halves were evaluated by blinded physicians for overall aesthetic scar appearance, erythema, and thickness, and every patient rated the degree of redness, itchiness, burning, and pain. A follow-up patient phone interview was also conducted to determine scar appearance differences. In these comparisons, no statistical differences were found. Khoo et al.5 conducted a prospective, randomized, double-blind study comparing 5% topical tocotrienol (vitamin E) and a placebo cream. Of the 122 patients enrolled in the study, 85 completed the study. In the treated group, 5% topical tocotrienol was applied to the scars 2 weeks after surgery two times a day for 6 weeks. The scars were evaluated by a 10-point Patient and Observer Scar Assessment Scale, in which the patients rated pain, itchiness, color, stiffness, thickness, and irregularity, and the clinical observer scored scar vascularization, pigmentation, pliability, thickness, and relief. Scar photos were taken and assessed by two independent surgeons, and laser Doppler imaging was performed to detect dermal vascularity. Twice-daily application of 5% topical tocotrienol had no significant effect on scar reduction, appearance, and vascularity. Limitations of many published clinical studies report testing single ingredients rather than the combined ingredients of many OTC scar products. More randomized clinical trials are needed to compare the OTC products containing the combined ingredients. In addition, consistent standardized objective measurements are needed to evaluate and compare scar product efficacy between studies.
Laryngoscope 125: February 2015
1
Future strategies to reduce scars may use antiproliferative cytokines (such as transforming growth factor b3). The concept of prophylactically administering cytokines to affect healing is an intriguing future strategy.
BEST PRACTICE Currently, the initial standard of care to minimize postincision scarring during epithelialization is to keep the incision moist, clean, and protected from tension and mobility. After the incision is closed, silicone gel, cyanoacrylates, and paper taping have shown promise in reducing postincision dermal scarring in clinical trials. The topical use of vitamin E and onion extracts have not been shown to reduce scars in clinical trials.
LEVEL OF EVIDENCE The article references are all level 1.
BIBLIOGRAPHY 1. Giorgi VS, Sestini S, Mannone F, et al. The use of silicone gel in the treatment of fresh surgical scars: a randomized study. Clin Exp Dermatol 2009;34:688–693. 2. Atkinson JA, McKenna KT, Barnett AG, et al. A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that traverse Langer’s skin tension lines. Plast Reconstr Surg 2005;116:1648–1656. 3. Scuderi N, Dessy LA, Buccheri EM, et al. Phase 2 cross-over multicenter trial on the efficacy and safety of topical cyanoacrylates compared with topical silicone gel in the prevention of pathologic scars. Aesthetic Plast Surg 2011;35:373–381. 4. Chung VQ, Kelley L, Marra D, et al. Onion extract gel versus petrolatum emollient on new surgical scars: prospective double-blinded study. Dermatol Surg 2006;32:193–197. 5. Khoo TL, Halim AS, Zakaria Z, et al. A prospective, randomised, doubleblinded trial to study the efficacy of topical tocotrienol in the prevention of hypertrophic scars. J Plast Reconstr Aesthet Surg 2011;64:e137–e145.
Hom and Hom: Reducing Scars With Topical Products
283
Rhinological and Otological Society, Inc.
Do Topical Products Reduce Postincision Scars? David B. Hom, MD; Katherine A. Hom, MS, BS BACKGROUND A common question asked by patients who are healing from a surgical incision is, “What is the best product to use to minimize a scar?” Commercially, the many topical products on the market make it difficult to decide what is the best product to recommend. Each product claims to have its advantages in reducing scarring with its combination of ingredients. Often, many of these products are not regulated by the US Food and Drug Administration, because over the counter (OTC) products are not classified as a drug or device. Thus, the chosen topical antiscar product is frequently based on anecdotal evidence, physician bias, or patient preference. Silicone gel, paper tape, cyanoacrylates, onion extract, and vitamin E are commonly used topical products for postincision scars. This article reviews the evidence surrounding the use of these topical products to reduce postincision scarring (Table I).
LITERATURE REVIEW To evaluate the scar benefits of silicone gel, Giorgi et al.1 conducted a randomized, controlled trial in 110 patients comparing silicone gel to the control group receiving zinc oxide cream. The treatment group of 65 patients applied silicone gel twice a day for 60 days after suture removal. Forty-five patients applied zinc oxide cream as the control. The same dermatologists examined the scars over 8 months. Twenty-seven percent of patients in the treatment group had pathological scarring compared to 55% in the control group. Keloid scars did not develop in the treatment group, but were present in 11% of the control group. Hypertrophic scars formed in 9% of the silicone gel-treated group compared to 22% of the control group. Silicone gel was effective in improv-
From the Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery (D.B.H.), University of Cincinnati College of Medicine, Cincinnati, Ohio; and the University of California School of Medicine at Irvine (K.A.H.), Irvine, California, U.S.A. The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to David B. Hom, MD, Director, Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology–Head and Neck Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267-0528. E-mail: [email protected] DOI: 10.1002/lary.24768
Laryngoscope 125: February 2015
282
ing the scar appearance by making it softer, smoother, and flatter as well as minimizing scar tissue thickness. Atkinson et al.2 performed a scar comparison study of paper tape application to untapped incisions in a randomized, controlled trial of 70 patients. Specifically, the hypertrophic scar characteristics of cesarean section incisions were measured using international scar classification guidelines and utilizing ultrasound to record interdermal volume. At weeks 6 and 12 and at 6 months, paper tape statistically decreased scar volume compared to controls. After the patients completed the 12-weekperiod therapy, 0% of the treatment group developed hypertrophic scars compared to 41% of the control group. This study concluded that the odds of a hypertrophic scar was 13.6 times greater in patients who received no paper tape than in those who applied paper tape. The authors recommend leaving the tape on for at least 12 weeks after the sutures are removed . Limitations of this study were that only 39 out of 70 enrolled patients completed the study, and patients with a keloid history were excluded. To compare the effectiveness of topical cyanoacrylate to silicone gel in preventing pathological scarring, Scuderi et al.3 conducted a prospective, multicenter, cross-over phase 2 study in 85 patients. After bilateral mastoplasty, cyanoacrylate was applied to one side of the scar every 3 to 5 days, twice a day, for 3 months, and silicone gel was applied in a similar fashion. Patients and three blinded physicians rated the scar characteristics using a 10-point visual analog scale before treatment and then 12 months after treatment. Photos were taken after suture removal at 1 month and 12 months later. Objective evaluations with a magnification lens, caliper, and optical profilometry measured size, surface texture, and elevation of the scars. Both silicone gel and cyanoacrylate application showed improved postsurgical scar quality, with cyanoacrylates having less scar widening than silicone gel. The authors suggest that the beneficial properties of topical cyanoacrylate are its occlusion action, ability to resist traction, and protective barrier to infection. The effectiveness of topical onion extract-based gel compared to a petrolatum-based ointment was conducted by Chung et al.4 in a prospective, randomized, doubleblind study of 24 patients. Each scar had one-half receiving onion extract gel and the other half using petrolatum ointment at the time of suture removal. Patients applied the ointments three times daily for 8 weeks. Hom and Hom: Reducing Scars With Topical Products
TABLE I. Evidence Surrounding the Use of These Topical Products. Scar Product
Study
Incision Site
Application Frequency
Control
Length of Study
Scar Results
Level of Evidence
Silicone gel
Giorgi et al. 2009
Multiple skin sites on body
2 3 per day for 60 days
Zinc oxide cream
8 months
Reduced hypertrophic scar and keloids
1
Paper tape (Micropore) Cyanoacrylate (Wipescar) Onion extract gel (Mederma)
Atkinson et al. 2005
Abdomen skin
For 12 weeks
No tape
6 months
1
Scuderi et al. 2011
Breast skin Head, trunk, extremity skin
Silicone gel (Dermatix) Petrolatum ointment
12 months
Chung et al. 2006
Every 3–5 days for 3 months 3 3 per day for 8 weeks
12 weeks
Reduced hypertrophic scar Both products improved final scar outcome No improvement
1
Khoo et al. 2011
Multiple skin sites on body
2 3 per day for 6 weeks
Placebo cream
16 weeks
No improvement
1
Vitamin E (5% tocotrienol)
Using a visual log scale at 2, 8, and 12 weeks, the scar halves were evaluated by blinded physicians for overall aesthetic scar appearance, erythema, and thickness, and every patient rated the degree of redness, itchiness, burning, and pain. A follow-up patient phone interview was also conducted to determine scar appearance differences. In these comparisons, no statistical differences were found. Khoo et al.5 conducted a prospective, randomized, double-blind study comparing 5% topical tocotrienol (vitamin E) and a placebo cream. Of the 122 patients enrolled in the study, 85 completed the study. In the treated group, 5% topical tocotrienol was applied to the scars 2 weeks after surgery two times a day for 6 weeks. The scars were evaluated by a 10-point Patient and Observer Scar Assessment Scale, in which the patients rated pain, itchiness, color, stiffness, thickness, and irregularity, and the clinical observer scored scar vascularization, pigmentation, pliability, thickness, and relief. Scar photos were taken and assessed by two independent surgeons, and laser Doppler imaging was performed to detect dermal vascularity. Twice-daily application of 5% topical tocotrienol had no significant effect on scar reduction, appearance, and vascularity. Limitations of many published clinical studies report testing single ingredients rather than the combined ingredients of many OTC scar products. More randomized clinical trials are needed to compare the OTC products containing the combined ingredients. In addition, consistent standardized objective measurements are needed to evaluate and compare scar product efficacy between studies.
Laryngoscope 125: February 2015
1
Future strategies to reduce scars may use antiproliferative cytokines (such as transforming growth factor b3). The concept of prophylactically administering cytokines to affect healing is an intriguing future strategy.
BEST PRACTICE Currently, the initial standard of care to minimize postincision scarring during epithelialization is to keep the incision moist, clean, and protected from tension and mobility. After the incision is closed, silicone gel, cyanoacrylates, and paper taping have shown promise in reducing postincision dermal scarring in clinical trials. The topical use of vitamin E and onion extracts have not been shown to reduce scars in clinical trials.
LEVEL OF EVIDENCE The article references are all level 1.
BIBLIOGRAPHY 1. Giorgi VS, Sestini S, Mannone F, et al. The use of silicone gel in the treatment of fresh surgical scars: a randomized study. Clin Exp Dermatol 2009;34:688–693. 2. Atkinson JA, McKenna KT, Barnett AG, et al. A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that traverse Langer’s skin tension lines. Plast Reconstr Surg 2005;116:1648–1656. 3. Scuderi N, Dessy LA, Buccheri EM, et al. Phase 2 cross-over multicenter trial on the efficacy and safety of topical cyanoacrylates compared with topical silicone gel in the prevention of pathologic scars. Aesthetic Plast Surg 2011;35:373–381. 4. Chung VQ, Kelley L, Marra D, et al. Onion extract gel versus petrolatum emollient on new surgical scars: prospective double-blinded study. Dermatol Surg 2006;32:193–197. 5. Khoo TL, Halim AS, Zakaria Z, et al. A prospective, randomised, doubleblinded trial to study the efficacy of topical tocotrienol in the prevention of hypertrophic scars. J Plast Reconstr Aesthet Surg 2011;64:e137–e145.
Hom and Hom: Reducing Scars With Topical Products
283
