Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars
Primary Purpose
Hypertrophic or Keloid Scars
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Silicone gel Kelo-cort™;
Onion extract gel Contractubex™
Sponsored by
About this trial
This is an interventional prevention trial for Hypertrophic or Keloid Scars
Eligibility Criteria
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.
Sites / Locations
- CHA Gangnam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Silicone gel
Onion extract gel
No treatment
Arm 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.
Onion extract gel (Contractubex™; Merz Pharma, Frankfurt, Germany) From the day of suture removal, the treatment was applied three times daily for 3 months.
Subjects who assigned In the no treatment group did not receive any topical scar emollients.
Outcomes
Primary Outcome Measures
Scar scale (VSS and BIQ)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01861119
Brief Title
Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars
Official Title
Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
February 1, 2014 (Actual)
Study Completion Date
May 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic or Keloid Scars
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silicone gel
Arm Type
Experimental
Arm 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.
Arm Title
Onion extract gel
Arm Type
Active Comparator
Arm 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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Subjects who assigned In the no treatment group did not receive any topical scar emollients.
Intervention Type
Drug
Intervention Name(s)
Silicone gel Kelo-cort™;
Intervention Type
Drug
Intervention Name(s)
Onion extract gel Contractubex™
Primary Outcome Measure Information:
Title
Scar scale (VSS and BIQ)
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHA Gangnam Medical Center
City
Seoul
ZIP/Postal Code
135-081
Country
Korea, Republic of
12. IPD Sharing Statement
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Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars
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