This randomized controlled trial compares hydrophilic methacrylate gel versus beta-sitosterol ointment for early episiotomy wound healing. A total of 107 women who underwent mediolateral episiotomy during vaginal delivery were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54). Wound outcomes were assessed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. The primary outcome was the REEDA score (Redness, Edema, Ecchymosis, Discharge, Approximation). Secondary outcomes included patient-reported pain, cosmetic appearance, satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.
Wound healing following episiotomy 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 mediolateral episiotomy during vaginal delivery at a tertiary care maternity hospital in Qatar. Exclusion criteria included known dermatological conditions affecting wound healing, hypersensitivity to study products, systemic inflammatory disease, chronic conditions delaying healing (e.g., coagulation disorders, diabetes, anemia with Hb \<9 g/dl), prior perineal injury, surgery, or visible lesions, or inability to attend follow-up. A total of 107 women were allocated to receive either hydrophilic methacrylate gel (n=53) or beta-sitosterol ointment (n=54).Outcome assessments were performed by trained observers blinded to treatment allocation and by patients at two time points approximately 12 days apart. Observer-assessed outcomes used the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Patient-reported outcomes included pain, cosmetic appearance, overall satisfaction, perceived treatment effectiveness, ease of application, and likelihood of recommending treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
107
Topical ointment containing beta-sitosterol applied to the episiotomy/perineal wound site
Hydrophilic methacrylate-based hydrogel applied to the episiotomy/perineal wound site
Al Wakra Hospital
Doha, Qatar
Perineal Wound Healing Assessed by REEDA Scale
Measured using the REEDA scale (Redness, Edema, Ecchymosis, Discharge, Approximation) total score, where higher scores indicate worse wound healing, assessed by trained observers blinded to treatment allocation.
Time frame: Assessed at two time points: Day 5 postpartum and Day 12 postpartum
Complete Wound Healing (REEDA = 0) Assessed at Day 12
Proportion of participants with a REEDA total score of 0 (no observed redness, edema, ecchymosis, discharge, or approximation abnormality) at Day 12 postpartum, assessed by trained observers blinded to treatment allocation.
Time frame: Day 12 postpartum
Patient-Reported Pain
Patient-reported pain rated on a 5-category verbal scale (None/Mild/Moderate/Severe/Very severe), categorized as none or mild vs. moderate to very severe.
Time frame: Day 12 postpartum
Patient Satisfaction (Patient-Reported Outcome)
Patient-reported overall satisfaction with treatment (categorized as satisfied/very satisfied vs not satisfied).
Time frame: Day 12 postpartum
Treatment Effectiveness Perception (Patient-Reported Outcome)
Patient-reported perceived effectiveness of treatment (categorized as effective/very effective vs not effective).
Time frame: Day 12 postpartum
Perineal Cosmetic Appearance (Patient-Reported Outcome)
Patient-reported cosmetic appearance of the perineal wound (categorized as improved somewhat/significantly vs no change or worsened).
Time frame: Day 12 postpartum
Ease of Application (Patient-Reported Outcome)
Ease of applying the topical treatment, categorized as easy/very easy vs neutral or difficult.
Time frame: Day 12 postpartum
Likelihood of Treatment Recommendation (Patient-Reported Outcome)
Likelihood of recommending the treatment to others (categorized as likely/definitely recommend vs neutral or unlikely).
Time frame: Day 12 postpartum
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