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-MartÃnez 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