A comparison of the efficacy of silicone gel containing onion extract and aloe vera to silicone gel sheets to prevent postoperative hypertrophic scars and keloids

Phase 3

Completed

• Conditions: postoperative scarhypertrophic scarkeloid; Silicone gel; Onion extract; Aloe vera; Hypertrophic scars; keloids

• Registration Number: TCTR20200806004
• Lead Sponsor: Skin & Health Care Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-02-01
• Study Start: 2020-08-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female 18-60 years old
2. History of surgery 2 weeks before enrollment
3. Wound size more than 1.5 cm
4. Written informed consent to participate in the study

Exclusion Criteria

1. Any infection
2. Any wound producing significant amount of discharge, lacking normal epithelialization, or requiring dressing after surgery
3. Any systemic diseases (e.g. diabetes mellitus, vascular disorder, autoimmune disease)
4. History of topical or systemic steroid use prior 1 month
5. Receiving immunosuppressive drug, chemotherapy, or radiation
6. History of silicone, onion extract, and Aloe vera allergies
7. Diagnosed with cancer
8.Unable to follow up according to the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hypertrophic scar and keloid 12 weeks number of participants who develop hypertrophic scars and keloids

Secondary Outcome Measures

Name	Time	Method
Erythema and melanin values at 4,8 and 12 week Using Mexameter,Pliability value at 4,8 and 12 week Using Cutometer,Patient and Observer Scar Assessment Scale (POSAS) score at 4,8 and 12 week Patient and Observer Scar Assessment Scale (POSAS),Patient’s satisfaction score at 4,8 and 12 week Global Satisfaction 5-rating scale