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This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early cesarean section scar healing. Adult women who underwent cesarean delivery were randomly assigned to receive either hydrophilic methacrylate gel (n=58) or beta-sitosterol ointment (n=59). Scar outcomes were assessed by trained nurses blinded to treatment allocation and by patients at two time points approximately 12 days apart. The primary outcome was scar redness measured by the Vancouver Scar Scale. Secondary outcomes included pigmentation, pliability, scar height, and patient-reported measures including pain, itching, satisfaction, and treatment recommendation.
Wound healing following cesarean delivery is a complex biological process influenced by mechanical stress, inflammatory response, tissue perfusion, and patient-related factors. This prospective randomized single-blinded controlled trial enrolled adult women who underwent elective or emergency cesarean section at a tertiary care maternity hospital in Qatar. Exclusion criteria included surgical site infection at baseline, dermatological conditions affecting wound healing, hypersensitivity to study products, systemic inflammatory disease, or inability to attend follow-up. Participants were randomly assigned to receive either hydrophilic methacrylate gel (n=58) or beta-sitosterol ointment (n=59) applied to the cesarean incision site starting in the early postoperative period. Outcome assessments were performed by trained nurses blinded to treatment allocation and by patients at two time points approximately 12 days apart. Nurse-assessed outcomes used the Vancouver Scar Scale (vascularity/redness, pigmentation, pliability, scar height). Patient-reported outcomes used the Patient and Observer Scar Assessment Scale (pain, itching, color, thickness, stiffness, irregularity, satisfaction, perceived effectiveness, ease of application, likelihood of recommending treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-Sitosterol Ointment | Active Comparator | Topical beta-sitosterol ointment applied to cesarean section incision site during early postoperative period |
|
| Hydrophilic Methacrylate Gel | Experimental | Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site during early postoperative period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-Sitosterol Ointment | Drug | Topical ointment containing beta-sitosterol applied to cesarean section incision site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scar Redness (Vascularity) Assessed by Vancouver Scar Scale (VSS) | Measured using the Vancouver Scar Scale (VSS) - Vascularity subscale (score range: 0-3, where higher scores indicate worse redness), assessed by trained nurses blinded to treatment allocation. | Assessed at two time points: Day 5 postpartum and Day 12 postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Scar Pigmentation Assessed by Vancouver Scar Scale (VSS) | Measured using the Vancouver Scar Scale (VSS) - Pigmentation subscale (score range: 0-3, where higher scores indicate worse pigmentation). | Day 5 postpartum and Day 12 postpartum |
| Scar Height Assessed by Vancouver Scar Scale (VSS) |
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Inclusion Criteria:
Exclusion Criteria:
Female (only)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Wakra Hospital | Doha | 3050 | Qatar |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 2, 2026 | |
| Reset | May 27, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2026 | Apr 9, 2026 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 2, 2026 | May 27, 2026 |
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| Hydrophilic Methacrylate Gel | Drug | Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site |
|
Measured using the Vancouver Scar Scale (VSS) - Height subscale (score range: 0-3, where higher scores indicate greater scar thickness). |
| Day 5 postpartum and Day 12 postpartum |
| Patient-Reported Pain Assessed by Patient and Observer Scar Assessment Scale (POSAS) | Measured using the Patient and Observer Scar Assessment Scale (POSAS) - Pain item (score range: 1-10, where higher scores indicate worse pain). | Day 5 postpartum and Day 12 postpartum |
| Patient-Reported Itching Assessed by Patient and Observer Scar Assessment Scale (POSAS) | Measured using the Patient and Observer Scar Assessment Scale (POSAS) - Itching item (score range: 1-10, where higher scores indicate worse itching). | Day 12 postpartum |
| Patient Satisfaction (Patient-Reported Outcome) | Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied). | Day 12 postpartum |
| Treatment Effectiveness Perception (Patient-Reported Outcome) | Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective). | Day 12 postpartum |
| Likelihood of Treatment Recommendation (Patient-Reported Outcome) | Patient-reported likelihood of recommending the treatment to others (ordinal scale; higher values indicate greater likelihood). | Day 12 postpartum |
| Ease of Application (Patient-Reported Outcome) | Patient-reported ease of applying the topical treatment (ordinal scale; higher values indicate easier application). | Day 12 postpartum |