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Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars

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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

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.


Condition or disease Intervention/treatment Phase
Hypertrophic or Keloid Scars Drug: Silicone gel Kelo-cort™; Drug: Onion extract gel Contractubex™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars: a Randomized Controlled Trial
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : February 1, 2014
Actual Study Completion Date : May 1, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
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.
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.
Drug: Onion extract gel Contractubex™
No Intervention: No treatment
Subjects who assigned In the no treatment group did not receive any topical scar emollients.



Primary Outcome Measures :
  1. Scar scale (VSS and BIQ) [ Time Frame: 3 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861119


Locations
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Korea, Republic of
CHA Gangnam Medical Center
Seoul, Korea, Republic of, 135-081
Sponsors and Collaborators
CHA University

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Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01861119    
Other Study ID Numbers: KNC13-020
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Keloid
Hypertrophy
Cicatrix
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases