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The goal of this clinical trial is to compare the efficacy of three different topical applications in preventing hypertrophic scars in adults with scars healed after suturing. The main question it aims to answer is: Is Chitosan cream effective in preventing hypertrophic scars?
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:
This is a 3-arm single-blinded randomised controlled trial to study the efficacy of three topical applications in preventing hypertrophic scars. The general objective is to investigate the efficacy of Chitosan cream in preventing hypertrophic scars compared to other topical applications commonly used; silicone gel and olive oil. The hypothesis is that Chitosan cream shows comparable efficacy in preventing hypertrophic scars compared to silicone gel and olive oil.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone gel | Active Comparator | Silicone gel application twice a day for 8 weeks |
|
| Chitosan cream | Experimental | Chitosan cream application twice a day for 8 weeks |
|
| Olive oil | Placebo Comparator | Olive oil application twice a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chitosan cream | Device | Application of Chitosan cream twice daily for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) scores | Each item is rated on a 5-point score. The lowest score is '1' which corresponds to the situation of normal skin. Score '5' being the largest difference from normal skin. | Enrolment to 24 weeks |
| Scar Assessment and Rating (SCAR) Scale scores | Scores of clinical photographs of each scar by 3 plastic surgeons. Score '0' indicates conditions closest to normal skin. Maximum scores for each item range from 1 to 4, where higher scores indicate larger differences from normal skin. | Enrolment to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | Patients are to report any side effects that they experience with use of any topical application. Side effects encountered are recorded. | Enrolment to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esther HM Tan, MBBS | Contact | +6097673000 | esthertan@student.usm.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Raja Perempuan Zainab II | Not yet recruiting | Kota Bharu | Kelantan | 15586 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27806156 | Background | 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. | |
| 36355319 | Background | 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. |
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Patient privacy protection
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| Silicone Gel |
| Device |
Application of silicone gel twice a day for 8 weeks |
|
| Olive Oil Topical Oil | Device | Application of olive oil twice daily for 8 weeks |
|
| Hospital Pakar Universiti Sains Malaysia | Recruiting | Kubang Kerian | Kelantan | 16150 | Malaysia |
|
| Hospital Kuala Lumpur | Not yet recruiting | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
|
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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