Efficacy of Early Initiation of a Gel Containing Extractum Cepae, Heparin, and Allantoin for Scar Treatment: An Observational, Noninterventional Study of Daily Practice

January 2013 | Volume 12 | Issue 1 | Original Article | 38 | Copyright © January 2013


Gunter H. Willital MDa and Jeannette Simon MDb

aPediatric Surgical Research Institute Münster-Datteln, Münster, Germany bMerz Pharmaceuticals GmbH, Frankfurt, Germany

Abstract
Background: Contractubex® (Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a gel containing extractum cepae, heparin, and allantoin with proven efficacy in the prevention of excessive scarring and promotion of physiological scar formation.
Aim: To investigate the efficacy of early initiation of Contractubex in the prevention of excessive scarring and promotion of physiological scar formation.
Methods: In total, 1,268 patients were included in this observational, noninterventional study. Patients were assessed at visit 1 (within 3 weeks of the injury), when treatment was initiated, with subsequent assessments after 2 to 3 months of treatment, and at the end of the study (after 4 to 5 months of treatment). Parameters measured included scar size, color, and pliability (consistency/hardness), as well as patients' and physicians' subjective assessments of treatment efficacy and tolerability.
Results: After 2 to 3 months of treatment, there were statistically significant improvements in color and pliability of the scar, sensation of pain, tension, and pruritus compared with visit 1 (P<.0001). By the end of the study, further statistically significant improvements compared with visit 1 were observed for all parameters. Only about 1% of scars were rated as markedly red or markedly hardened at the final visit. In addition, there was a reduction of 31.5% in mean scar width and of 47.8% in mean scar height at the end of the observation period. A high percentage of patients (85.8%) and physicians (86.6%) rated the treatment as good or very good with respect to prevention of excessive scarring and promotion of physiological scar development. Tolerability was described as good or very good by 92.0% of physicians and 91.5% of patients.
Conclusions: The results of this study suggest that the scar gel is effective in preventing excessive scarring and promoting physiological scar formation when treatment is initiated early. In addition, the treatment was well tolerated.

J Drugs Dermatol. 2013;12(1):38-42.

INTRODUCTION

Scarring in the skin after surgery or accidental injury is a common medical problem. There are estimated to be approximately 44 million surgical procedures per year in the United States (unpublished data, Mattson Jack Group) and 42 million in the European Union (unpublished data, MedTech Insights and TforG) that could benefit from scar-reduction therapy.1 A recent survey of 97 patients and 24 clinicians revealed that patients were dissatisfied with the appearance of their scars resulting from surgery, irrespective of gender, age, and ethnicity. Furthermore, 91% of patients surveyed reported that they would value even a small improvement in scarring.2 These findings are supported by the large number of patients who seek scar revision surgery each year (a total of 171,000 patients in the United States in 2009).3
It is known that patients suffer both physically and psychologically as a result of scarring. Physical suffering often occurs when scars negatively affect functionality, especially when located over a joint. The lack of elasticity may severely impede mobility. This is particularly common after extensive injuries to the skin and softer tissue from burns or inflammation.
Severe scarring may also affect patients psychologically. Larger scar size has been significantly associated with self-consciousness and anxiety levels in patients with only minor facial injuries.4 In 50 patients who had suffered facial trauma, there was a significant positive correlation between patients’ self-perception of facial disfigurement scores and scores obtained in both the anxiety and depression subscales of the Hospital Anxiety and Depression Scale.5 One-quarter of patients with a scar from congenital heart disease surgery (sternotomy, thoracotomy, or both) “did not like” or “hated” their scars.6
Despite the great need for effective therapies, scar treatment remains challenging. A wide variety of approaches have been employed, from the invasive (steroid injections, cryotherapy, and surgery) to the noninvasive (silicone gel sheeting, pressure garments, hydrating creams, and ointments).1,7 To date, a combination including various approaches is frequently favored.8 However, even today, established scars are particularly difficult to treat and effective prophylaxis remains of crucial importance. Options for prophylactic therapy are limited, but specific topical medications containing appropriate active substances are fre-
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