The Prophylactic Use of a Topical Scar Gel Containing Extract of Allium Cepae, Allantoin, and Heparin Improves Symptoms and Appearance of Cesarean-Section Scars Compared With Untreated Scars

February 2014 | Volume 13 | Issue 2 | Original Article | 176 | Copyright © February 2014


Jorge Ocampo-Candiani MD,a Osvaldo T. Vázquez-Martínez MD,a José Luis Iglesias Benavides MD,b Kristin Buske MD,c Annette Lehn,d and Clemens Acker MDd

aDepartment of Dermatology, Hospital Universitario 'Dr. José E. González', Universidad Autónoma de Nuevo León, Monterrey, NL, México
bDepartment of Obstetrics and Gynecology, Hospital Universitario 'Dr. José E. González', Universidad Autónoma de Nuevo León, Monterrey, NL, México
cTeva GmbH, Ulm, Germany
dMerz Pharmaceuticals GmbH, Frankfurt, Germany

Abstract
BACKGROUND: Abdominal Cesarean sections (C-sections) are frequently associated with an increased risk of excessive or unpleasant scarring. A topical scar gel containing extract of Allium cepae, allantoin and heparin (Contractubex®; Merz Pharmaceuticals GmbH, Germany), has shown efficacy in improving the appearance of various scar types.
OBJECTIVE: To investigate the efficacy of the topical scar gel, Contractubex, in the early treatment of C-section scars.
MATERIALS & METHODS: A total of 61 females, aged ≥18 years, who had given birth by elective C-section for the first time within the last 5–10 days, were included in this prospective, randomized, single-center study. Patients were advised to apply the topical scar gel twice daily (treatment group), or received no treatment (control group). Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient and Observer Scar Assessment Scale (POSAS), a validated scar assessment tool comprised of a Patient Scale and an Observer Scale.
RESULTS: Analysis revealed a significant change in the POSAS Patient Scale total score, with a 14.2% improvement in the treatment group compared with a decline of similar magnitude (−14.8%) in the control group at week 6. Significant improvements were also seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color (13.6% vs −18.5%, respectively, P=0.0284), stiffness (12.5% vs −34.6%, respectively, P=0.0029), and irregularity (29.4% vs −46.2%, respectively, P=0.0140) after 6 weeks of treatment. No significant changes were observed for the POSAS Observer Scale total score or its subitems after treatment with the topical scar gel, although there was a strong overall trend in favor of the treatment group. No significant adverse events were observed during the study.
CONCLUSION: Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves the color, stiffness and irregularity of C-section scars.

J Drugs Dermatol. 2014;13(1):176-182.

INTRODUCTION

Cesarean section (C-section) is one of the most common abdominal operations performed on women and the incidence of this procedure has increased dramatically in recent years, comprising 20–25% of all births in most developed countries.1-3 Numerous studies have shown that scars resulting from C-sections are comparable, particularly in terms of cosmetic appearance, regardless of the technique used for skin closure (eg, staples or stitches).4-6 Along with other physical and emotional traumas associated with a C-section, the immediate problem of healing of the incision and the emerging scar can have a substantial negative effect on the well-being of the patient. In addition to pain, discomfort, and excessive scar formation, some women also report loss of feeling around the scar, whereas others experience hypersensitivity to any touch or pressure applied to the scar area – an effect that may be psychologic as well as physical.7 Since C-sections represent such a common surgical procedure, identification of an appropriate means to minimize post-surgical scarring is crucial.
Scars form as a result of the complex physiologic wound healing cascade following any insult to the deep dermis.8 Several factors, such as specific anatomic locations, prolonged inflammation, and delayed epithelialization and genetic susceptibility, contribute significantly to an increased risk of developing excessive or unpleasant scarring.8 A number of different approaches have been used in an effort to manage scarring following surgery, ranging from invasive approaches (intralesional triamcinolone acetonide, cryotherapy, radiation, laser therapy, interferon, 5-fluorouracil [5-FU], and surgical excision) to non-invasive approaches (mainly prophylactic techniques, including silicone gel [sheeting], pressure therapy, and ointments containing extract of Allium cepae [onion extract]).9