Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil
NCT ID: NCT07269093
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-12-21
2026-11-30
Brief Summary
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Researchers will compare Chitosan cream with silicone gel and olive oil to see if there is any difference in their efficacies.
Participants will be randomly assigned to three groups, with each group using a different topical application. They will be instructed to:
* apply the topical application on their scar twice a day for 8 weeks
* attend follow-up visits at 4, 12 and 24 weeks for a doctor to assess their scar and take clinical photographs
* immediately inform the researcher if they experience any side effects
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Detailed Description
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The study population consists of patients who had traumatic or surgical scars that have healed by primary intention in the Unit of Reconstructive Sciences, Hospital Pakar USM, Plastic \& Reconstructive Surgery Unit of Hospital Raja Perempuan Zainab II and the Plastic \& Reconstructive Surgery Department of Hospital Kuala Lumpur and have met the study inclusion criteria.
Patients who meet the inclusion criteria will be given a topical application (Chitosan cream / silicone gel / olive oil) which is assigned randomly by computer software (SPSS version 29). The topical applications is to be applied twice daily from the 14th day since wounding. The investigator will be blinded to the topical application given to the patient. Both patient and investigator will assess the scar using Patient \& Observer Scar Assessment Scale (POSAS) version 3.0 and scars will be photographed under fixed camera settings \& lighting conditions. Patients will come for follow-up on weeks 4, 12 \& 24 and the scar assessment will be repeated by both patient \& the same observer. Serial photographs will also be taken each visit. At the end of the 24 weeks, photographs of the scars will be reviewed by three independent plastic surgeons and scored using the Scar Cosmesis \& Assessment Rating (SCAR) Scale. Both the scores from the clinical \& photographic scar assessments will be evaluated to compare the efficacy of each topical application. The duration of the study is from Nov 2025-Nov 2026.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Silicone gel
Silicone gel application twice a day for 8 weeks
Silicone Gel
Application of silicone gel twice a day for 8 weeks
Chitosan cream
Chitosan cream application twice a day for 8 weeks
Chitosan cream
Application of Chitosan cream twice daily for 8 weeks
Olive oil
Olive oil application twice a day for 8 weeks
Olive Oil Topical Oil
Application of olive oil twice daily for 8 weeks
Interventions
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Chitosan cream
Application of Chitosan cream twice daily for 8 weeks
Silicone Gel
Application of silicone gel twice a day for 8 weeks
Olive Oil Topical Oil
Application of olive oil twice daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Length of scar at least 3cm
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Universiti Sains Malaysia
OTHER
Responsible Party
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Esther Tan Hui Min
Dr
Locations
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Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, Malaysia
Hospital Pakar Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
Carriere ME, Mokkink LB, Tyack Z, Westerman MJ, Pijpe A, Pleat J, van de Kar AL, Brown J, de Vet HCW, van Zuijlen PPM. Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study. Qual Life Res. 2023 Feb;32(2):583-592. doi: 10.1007/s11136-022-03244-6. Epub 2022 Nov 10.
Other Identifiers
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USM/JEPeM/KK/25060539
Identifier Type: -
Identifier Source: org_study_id
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