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Completed

NCT Number: NCT07547462

Optimizing Early Cesarean Scar Healing

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.

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Key information

Conditions

Cesarean Section Scar Wound Healing

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Wakra Hospital

Doha, 3050, Qatar

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beta-Sitosterol Ointment

Drug

Topical ointment containing beta-sitosterol applied to cesarean section incision site

Hydrophilic Methacrylate Gel

Drug

Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site

Primary outcomes

  1. Scar Redness (Vascularity) Assessed by Vancouver Scar Scale (VSS)

    Time frame: 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 outcomes

  1. Scar Pigmentation Assessed by Vancouver Scar Scale (VSS)

    Time frame: 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).

  2. Scar Height Assessed by Vancouver Scar Scale (VSS)

    Time frame: 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).

  3. Patient-Reported Pain Assessed by Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 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).

  4. Patient-Reported Itching Assessed by Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 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).

  5. Patient Satisfaction (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).

  6. Treatment Effectiveness Perception (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).

  7. Likelihood of Treatment Recommendation (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported likelihood of recommending the treatment to others (ordinal scale; higher values indicate greater likelihood).

  8. Ease of Application (Patient-Reported Outcome)

    Time frame: Day 12 postpartum

    Patient-reported ease of applying the topical treatment (ordinal scale; higher values indicate easier application).

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

Optimizing Early Cesarean Scar Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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