Chitosan cream versus silicone gel and olive oil for preventing hypertrophic scars
Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
We will test whether applying chitosan cream twice daily can prevent hypertrophic scars in adults whose surgical or traumatic wounds have healed by primary intention within 14 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 3 sites (Kota Bharu, Kelantan and 2 other locations) |
| Trial ID | NCT07269093 on ClinicalTrials.gov |
What this trial studies
This is a three-arm, single-blinded, randomized trial comparing chitosan cream, silicone gel, and olive oil applied twice daily for eight weeks starting on day 14 after wound closure. Participants are randomized to one of the three topicals, with standardized clinical photographs and scar assessments using the Patient & Observer Scar Assessment Scale (POSAS) version 3.0 at weeks 4, 12, and 24. The investigator assessing outcomes is blinded to allocation while patients apply the assigned product and report any side effects. The trial recruits adults with primary-intention surgical or traumatic scars of at least 3 cm from three Malaysian hospitals.
Who should consider this trial
Good fit: Adults with traumatic or surgical wounds healed by primary intention within 14 days, scars at least 3 cm in length, no prior scar treatments, and no seafood allergy are the intended participants.
Not a fit: Patients with a history of keloids or hypertrophic scars, wounds complicated by infection or breakdown, scars under 3 cm, pregnant people, or those with seafood allergy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, chitosan cream could provide a simple topical option to reduce hypertrophic scar formation and improve scar appearance and symptoms.
How similar studies have performed: Silicone gel has prior evidence of modest benefit for scar prevention, chitosan topical formulations are relatively novel with limited clinical data, and olive oil is traditional but not proven in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with traumatic or surgical wounds which have healed by primary intention within 14 days * Length of scar at least 3cm Exclusion Criteria: * 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
Where this trial is running
Kota Bharu, Kelantan and 2 other locations
- Hospital Raja Perempuan Zainab II — Kota Bharu, Kelantan, Malaysia (Not_yet_recruiting)
- Hospital Pakar Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (Recruiting)
- Hospital Kuala Lumpur — Kuala Lumpur, Kuala Lumpur, Malaysia (Not_yet_recruiting)
Study contacts
- Study coordinator: Esther HM Tan, MBBS
- Email: esthertan@student.usm.my
- Phone: +6097673000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.