Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars

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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Key information

Conditions

Hypertrophic or Keloid Scars Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Hypertrophy Keloid Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHA Gangnam Medical Center

Seoul, 135-081, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Silicone gel Kelo-cort™;

Drug

Onion extract gel Contractubex™

Drug

Primary outcomes

Scar scale (VSS and BIQ)

Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars: a Randomized Controlled Trial

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 23, 2013
Registry last updated: Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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