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Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861119
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University

Tracking Information
First Submitted Date  ICMJE May 21, 2013
First Posted Date  ICMJE May 23, 2013
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE April 1, 2013
Actual Primary Completion Date February 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
Scar scale (VSS and BIQ) [ Time Frame: 3 months after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars
Official Title  ICMJE Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars: a Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hypertrophic or Keloid Scars
Intervention  ICMJE
  • Drug: Silicone gel Kelo-cort™;
  • Drug: Onion extract gel Contractubex™
Study Arms  ICMJE
  • Experimental: Silicone gel
    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.
    Intervention: Drug: Silicone gel Kelo-cort™;
  • Active Comparator: Onion extract gel
    Onion extract gel (Contractubex™; Merz Pharma, Frankfurt, Germany) From the day of suture removal, the treatment was applied three times daily for 3 months.
    Intervention: Drug: Onion extract gel Contractubex™
  • No Intervention: No treatment
    Subjects who assigned In the no treatment group did not receive any topical scar emollients.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2016)
90
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2013)
60
Actual Study Completion Date  ICMJE May 1, 2014
Actual Primary Completion Date February 1, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01861119
Other Study ID Numbers  ICMJE KNC13-020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taejong Song, CHA University
Study Sponsor  ICMJE CHA University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHA University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP