Chitosan cream versus silicone gel and olive oil for preventing hypertrophic scars
Official title: Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
Run by Universiti Sains Malaysia · NCT07269093 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 3 sites (Kota Bharu, Kelantan and 2 other locations) |
| Status | Recruiting |
| Started | December 21, 2025 |
| Main results expected | November 2026 |
| Study ends | November 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07269093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Hospital Pakar Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia Recruiting -
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia Not yet 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.