Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07269093

Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil

Led by Universiti Sains Malaysia · Updated on 2026-01-02

120

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of three different topical treatments—Chitosan cream, silicone gel, and olive oil—in preventing hypertrophic scars in adults whose scars have healed after suturing. This randomized controlled trial aims to compare these treatments to determine if Chitosan cream is as effective as the commonly used silicone gel and olive oil in scar prevention. The study involves adults with traumatic or surgical scars healed by primary intention within 14 days. Participants will be randomly assigned to one of three groups, each applying a different topical treatment twice daily for 8 weeks starting from the 14th day after wounding. The treatments being studied are Chitosan cream, silicone gel, and olive oil. This single-blinded study includes follow-up visits at 4, 12, and 24 weeks, during which scars will be assessed and photographed under standardized conditions. Participants will be monitored through clinical assessments using the Patient and Observer Scar Assessment Scale (POSAS) and photographs reviewed with the Scar Cosmesis and Assessment Rating (SCAR) Scale. Both patients and investigators will evaluate the scars at each visit. Any side effects will be reported immediately. The study duration spans from November 2025 to November 2026, with the main outcomes measured from enrollment up to 24 weeks.

CONDITIONS

Brief Title

Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with traumatic or surgical wounds which have healed by primary intention within 14 days
  • Length of scar at least 3cm
  • Adults aged 18 to 65 years
Not Eligible

You will not qualify if you...

  • Patients with seafood allergy
  • Patients with scar from wounds that were complicated by infection or wound breakdown
  • Patients who have undergone scar treatment by other modalities
  • Patients with history of keloids / hypertrophic scars
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 8 weeks

Participants apply their assigned topical product (Chitosan cream, silicone gel, or olive oil) twice daily starting from 14 days after wound healing to prevent hypertrophic scars.

1 baseline visit and 3 follow-up visits at weeks 4, 12, and 24

Long-term Monitoring

Duration - Up to 24 weeks from enrollment

Participants and investigators assess scar appearance through standardized scales and photographs to evaluate treatment efficacy and side effects.

Follow-up visits at weeks 4, 12, and 24 with scar assessments and photographs

Trial Site Locations

Total: 3 locations

1

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia, 15586

Not Yet Recruiting

2

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia, 16150

Actively Recruiting

3

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, Malaysia, 50586

Not Yet Recruiting

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Research Team

E

Esther HM Tan, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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