Cesarean Section ScarNCT07547462
Optimizing Early Cesarean Scar Healing
A study testing Beta-Sitosterol Ointment and Hydrophilic Methacrylate Gel in people with Cesarean Section Scar and Wound Healing, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Scar, Wound Healing
- What is being tested?
- Beta-Sitosterol Ointment and Hydrophilic Methacrylate Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteQatar
- Study dates
- 15 Dec 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Underwent elective or emergency cesarean section
- Uncomplicated postoperative course at enrollment ((no infection or major complications)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Early Cesarean Scar Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment
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.
Read the 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).
- Conditions
- Cesarean Section Scar, Wound Healing
- Being tested
- Beta-Sitosterol Ointment, Hydrophilic Methacrylate Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-Sitosterol OintmentDrug
Topical ointment containing beta-sitosterol applied to cesarean section incision site
Hydrophilic Methacrylate GelDrug
Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site
| Study group | Role | What they receive |
|---|---|---|
| Beta-Sitosterol Ointment | Active comparator | Topical beta-sitosterol ointment applied to cesarean section incision site during early postoperative period Receives: Drug: Beta-Sitosterol Ointment |
| Hydrophilic Methacrylate Gel | Experimental | Hydrophilic methacrylate-based hydrogel applied to cesarean section incision site during early postoperative period Receives: Drug: Hydrophilic Methacrylate Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at two time points: Day 5 postpartum and Day 12 postpartum
Secondary outcomes (8)
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).
Measured: Day 5 postpartum and Day 12 postpartum
Scar Height Assessed by Vancouver Scar Scale (VSS)
Measured using the Vancouver Scar Scale (VSS) - Height subscale (score range: 0-3, where higher scores indicate greater scar thickness).
Measured: 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).
Measured: 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).
Measured: Day 12 postpartum
Patient Satisfaction (Patient-Reported Outcome)
Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).
Measured: Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)
Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).
Measured: 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).
Measured: Day 12 postpartum
Ease of Application (Patient-Reported Outcome)
Patient-reported ease of applying the topical treatment (ordinal scale; higher values indicate easier application).
Measured: Day 12 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 Dec 2023
- Primary completion8 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Yehia El Khawly, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547462
- Sponsor's protocol ID
- 01-23-518
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Early Cesarean Scar Healing: A Randomized Controlled Trial of Hydrophilic Methacrylate Gel Versus Beta-Sitosterol Ointment
- ClinicalTrials.gov ID
- NCT07547462
- Acronym / sponsor ID
- 01-23-518
- Conditions
- Cesarean Section Scar, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-Sitosterol Ointment | Active comparator | Drug: Beta-Sitosterol OintmentTopical beta-sitosterol ointment applied to cesarean section incision site during early postoperative period |
| Hydrophilic Methacrylate Gel | Experimental | Drug: Hydrophilic Methacrylate GelHydrophilic methacrylate-based hydrogel applied to cesarean section incision site during early postoperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Underwent elective or emergency cesarean section
- Uncomplicated postoperative course at enrollment ((no infection or major complications)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-Sitosterol OintmentTopical ointment containing beta-sitosterol applied to cesarean section incision site | Drug | Beta-Sitosterol Ointment |
| Hydrophilic Methacrylate GelHydrophilic methacrylate-based hydrogel applied to cesarean section incision site | Drug | Hydrophilic Methacrylate Gel |
Primary outcome
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.
8 secondary outcomes
Scar Pigmentation Assessed by Vancouver Scar Scale (VSS)
Time frame: Day 5 postpartum and Day 12 postpartum
Scar Height Assessed by Vancouver Scar Scale (VSS)
Time frame: Day 5 postpartum and Day 12 postpartum
Patient-Reported Pain Assessed by Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Day 5 postpartum and Day 12 postpartum
Patient-Reported Itching Assessed by Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Day 12 postpartum
Patient Satisfaction (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Likelihood of Treatment Recommendation (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Ease of Application (Patient-Reported Outcome)
Time frame: Day 12 postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Sitosterol Ointment and Hydrophilic Methacrylate Gel in people with Cesarean Section Scar and Wound Healing, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Redness (Vascularity) Assessed by Vancouver Scar Scale (VSS) (time frame: Assessed at two time points: Day 5 postpartum and Day 12 postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.