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Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars

NCT01861119 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Hypertrophic or Keloid Scars

Interventions

DRUG

Silicone gel Kelo-cort™;

DRUG

Onion extract gel Contractubex™

Sponsors & Collaborators

  • CHA University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2014-02-01
Completion
2014-05-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01861119 on ClinicalTrials.gov