Cesarean Section Scar, Wound Healing
Conditions
Brief summary
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.
Detailed description
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).
Interventions
Topical ointment containing beta-sitosterol applied to cesarean section incision site
Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site
Sponsors
Hamad Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Underwent elective or emergency cesarean section * Uncomplicated postoperative course at enrollment ((no infection or major complications)
Exclusion criteria
* Evidence of surgical site infection at baseline * Known dermatological conditions affecting wound healing * Hypersensitivity to study products * Systemic inflammatory disease * Inability to attend follow-up appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Redness (Vascularity) Assessed by Vancouver Scar Scale (VSS) | Assessed at two time points: Day 5 postpartum and Day 12 postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar Pigmentation Assessed by Vancouver Scar Scale (VSS) | Day 5 postpartum and Day 12 postpartum | Measured using the Vancouver Scar Scale (VSS) - Pigmentation subscale (score range: 0-3, where higher scores indicate worse pigmentation). |
| Scar Height Assessed by Vancouver Scar Scale (VSS) | Day 5 postpartum and Day 12 postpartum | Measured using the Vancouver Scar Scale (VSS) - Height subscale (score range: 0-3, where higher scores indicate greater scar thickness). |
| Patient-Reported Pain Assessed by Patient and Observer Scar Assessment Scale (POSAS) | Day 5 postpartum and Day 12 postpartum | Measured using the Patient and Observer Scar Assessment Scale (POSAS) - Pain item (score range: 1-10, where higher scores indicate worse pain). |
| Patient-Reported Itching Assessed by Patient and Observer Scar Assessment Scale (POSAS) | Day 12 postpartum | Measured using the Patient and Observer Scar Assessment Scale (POSAS) - Itching item (score range: 1-10, where higher scores indicate worse itching). |
| Patient Satisfaction (Patient-Reported Outcome) | Day 12 postpartum | Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied). |
| Treatment Effectiveness Perception (Patient-Reported Outcome) | Day 12 postpartum | Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective). |
| Likelihood of Treatment Recommendation (Patient-Reported Outcome) | Day 12 postpartum | Patient-reported likelihood of recommending the treatment to others (ordinal scale; higher values indicate greater likelihood). |
| Ease of Application (Patient-Reported Outcome) | Day 12 postpartum | Patient-reported ease of applying the topical treatment (ordinal scale; higher values indicate easier application). |
Countries
Qatar
Outcome results
None listed