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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone gel | Experimental | Silicone gel (Kelo-cortâ„¢; Advanced Bio-Technologies, Silverdale, WA, USA) From the day of suture removal, the treatment was applied three times daily for 3 months. |
|
| Onion extract gel | Active Comparator | Onion extract gel (Contractubexâ„¢; Merz Pharma, Frankfurt, Germany) From the day of suture removal, the treatment was applied three times daily for 3 months. |
|
| No treatment | No Intervention | Subjects who assigned In the no treatment group did not receive any topical scar emollients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone gel Kelo-cortâ„¢; | Drug |
| ||
| Onion extract gel Contractubexâ„¢ |
| Measure | Description | Time Frame |
|---|---|---|
| Scar scale (VSS and BIQ) | 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Gangnam Medical Center | Seoul | 135-081 | South Korea |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| D007627 | Keloid |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
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| Drug |
|
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |