Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars

CHA University

Status and phase: Completed; Phase 3

Conditions: Hypertrophic or Keloid Scars

Treatments: Drug: Silicone gel Kelo-cort™;; Drug: Onion extract gel Contractubex™

Study type: Interventional

Funder types: Other

Identifiers

NCT01861119

KNC13-020

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. over 18 years of age,
2. Asian,
3. at least 3 cm sized surgical wound in total length,
4. nonpregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks),
5. able to read and write informed consent and questionnaire.

Exclusion criteria

1. women who received nearly scar-free surgery such as laparoendoscopic single-site (LESS) surgery or natural orifice transluminal surgery (NOTES);
2. women who developed surgical complications such as wound infection
3. women who had a history of hypertrophic or keloid scarring in abdomen
4. women who were taking chemotherapeutic agents or other medications that would affect wound healing, such as steroids
5. women who had comorbidities such as diabetes, contractive skin disorders (e.g., scleroderma), or active dermatologic conditions
6. women who had allergy to silicone or onion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Silicone gel

Experimental group

Description:

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.

Treatment:

Drug: Silicone gel Kelo-cort™;

Onion extract gel

Active Comparator group

Description:

Onion extract gel (Contractubex™; Merz Pharma, Frankfurt, Germany) From the day of suture removal, the treatment was applied three times daily for 3 months.

Treatment:

Drug: Onion extract gel Contractubex™

No treatment

No Intervention group

Description:

Subjects who assigned In the no treatment group did not receive any topical scar emollients.