Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01861119|
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : August 28, 2019
Hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. The subjective opinion of the patient regarding the scar will often constitute the standard for judging the success or failure of the procedure. Surgical scars are not only a cosmetic concern but they can also cause pain, itching, discomfort, contracture, and other functional impairment. Various treatment options exists for treating hypertrophic scars and keloids, including intralesional steroid injection, dermabrasion, pressure therapy, surgical excision, radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. However, these treatments often require multiple visits and have limited success. Therefore, prevention and early recognition of hypertrophic scars and keloids are very important in their management.
Among preventive treatments available, silicone gel and onion extract gel have been marketed as products to improve the appearance and texture of surgical scars. Despite its popularity, data demonstrating the efficacy of these gels are lacking. Furthermore, there is no comparative study of silicone gel and onion extract gel for preventing postsurgical hypertrophic or keloid scars. The investigators therefore conducted this randomized controlled trial to compare the efficacy of silicone gel and onion extract gel for the prevention of postsurgical hypertrophic scars. The investigators also compared patient compliance and side effect between two topical gels.
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic or Keloid Scars||Drug: Silicone gel Kelo-cort™; Drug: Onion extract gel Contractubex™||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars: a Randomized Controlled Trial|
|Actual Study Start Date :||April 1, 2013|
|Actual Primary Completion Date :||February 1, 2014|
|Actual Study Completion Date :||May 1, 2014|
Experimental: Silicone gel
Silicone gel (Kelo-cort™; Advanced Bio-Technologies, Silverdale, WA, USA) From the day of suture removal, the treatment was applied three times daily for 3 months.
Drug: Silicone gel Kelo-cort™;
Active Comparator: Onion extract gel
Onion extract gel (Contractubex™; Merz Pharma, Frankfurt, Germany) From the day of suture removal, the treatment was applied three times daily for 3 months.
Drug: Onion extract gel Contractubex™
No Intervention: No treatment
Subjects who assigned In the no treatment group did not receive any topical scar emollients.
- Scar scale (VSS and BIQ) [ Time Frame: 3 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861119
|Korea, Republic of|
|CHA Gangnam Medical Center|
|Seoul, Korea, Republic of, 135-081|