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

table 1
Patient-reported Subjective Impression of Skin Sensation
Reduction in scar size correlated with an improvement in skin sensation in the scar area. At visit 1, the majority of patients (62.6%) reported feelings of tension in the scar area. Nearly half of patients (42.4%) reported sensitivity to pain, while 33.4% reported pruritus (itchiness) (Figure 3). At visit 2, all 3 parameters had improved significantly compared with visit 1 (P<.0001 for each parameter). At visit 3, the percentage of patients reporting feelings of tension had decreased to 10%, with 12.8% reporting pain and 7.6% reporting pruritus (P<.0001 compared with visit 1 for each parameter).
Patient-reported Medication Properties
At visit 2, patients took part in a survey to assess the properties of the scar medication to investigate to what extent the medication met patient needs. Almost all patients (96.7%) rated the aroma as pleasant or neutral, and 84.4% of patients rated spreadability as very good. Only 3% of patients reported that the gel was absorbed into the skin slowly, while 54.6% of patients described the absorption rate as rapid. The subjective impression of 79.5% of patients was that skin sensation had improved. Suitability of the scar gel containing extractum cepae, heparin, and allantoin for the treatment of local wound healing with respect to prevention of excessive scarring and promotion of physiological scar formation was rated as good or very good by 86.5% of physicians (95% confidence interval [CI]: 85.5, 88.4) and 85.8% of patients (95% CI: 83.8, 87.7) (Figure 4).
Safety
Tolerability was described as good or very good by 92.0% of physicians (95% CI: 90.3, 93.4) and 91.5% of patients (95% CI: 89.8, 93.0) (Figure 5). Three patients (0.2%) experienced reversible adverse events in the form of local skin reactions.

DISCUSSION

Irrespective of the underlying cause of the injury—whether from an accident or surgical intervention—it is generally difficult to predict the course of scar formation. Genetic susceptibility, specific anatomic locations, prolonged inflammation, and delayed epithelialization may significantly contribute to an increased risk of developing abnormal or excessive scarring.8 Besides the poor aesthetic appearance, excessive scarring can be associated with severe clinical symptoms such as pain, itching, and rigidity, thus significantly affecting the patient’s quality of life both physically and psychologically. Currently, a variety of scar treatment options are available, with the respective treatment choice ultimately depending on the wound-healing stage and nature of the scar. Existing therapeutic strategies include intralesional triamcinolone acetonide, cryosurgery, radiation, laser therapy, 5-fluorouracil, and surgical excision. Nevertheless, therapy of established excessive scars remains challenging, and side effects with current therapeutic approaches are commonly observed. Since excessive scars may respond differently to the respective treatments, approaches frequently need to be combined or altered.
However, it is simpler—and a successful outcome is considerably more likely—to treat the scar at an early stage rather than attempting to remedy established hypertrophic scars or keloids at a later stage. Besides surgical approaches, such as achievement of rapid epithelialization and primary closure of wounds without tension, 3 main options for the prevention of excessive scarring are presently being discussed in the literature: pressure garments, silicone gel or silicone gel sheets, and the use of extractum cepae. Pressure therapy has been the preferred conservative method of prophylaxis and treatment of excessive scars since the 1970s. Recommendations for