Episiotomy, Perineal Wound Healing
Conditions
Keywords
Episiotomy, Wound Healing, Hydrophilic Methacrylate Gel, Beta-Sitosterol Ointment, REEDA Scale, Postpartum
Brief summary
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.
Detailed description
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.
Interventions
Topical ointment containing beta-sitosterol applied to the episiotomy/perineal wound site
Hydrophilic methacrylate-based hydrogel applied to the episiotomy/perineal wound 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 * Primigravida (first pregnancy) * Live term singleton pregnancy * Underwent mediolateral episiotomy without tear during vaginal delivery * Adequate reading and writing literacy
Exclusion criteria
* Known dermatological conditions affecting wound healing * Hypersensitivity to study products * Systemic inflammatory disease * Chronic systemic disease that delays wound healing (e.g., coagulation disorders, diabetes, anemia with Hb \<9 g/dl) * Prior perineal injury, surgery, or visible lesions (e.g., genital warts, hemorrhoids) * Inability to attend follow-up appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perineal Wound Healing Assessed by REEDA Scale | Assessed at two time points: Day 5 postpartum and Day 12 postpartum | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing (REEDA = 0) Assessed at Day 12 | Day 12 postpartum | 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. |
| Patient-Reported Pain | Day 12 postpartum | 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. |
| 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). |
| Perineal Cosmetic Appearance (Patient-Reported Outcome) | Day 12 postpartum | Patient-reported cosmetic appearance of the perineal wound (categorized as improved somewhat/significantly vs no change or worsened). |
| Ease of Application (Patient-Reported Outcome) | Day 12 postpartum | Ease of applying the topical treatment, categorized as easy/very easy vs neutral or difficult. |
| Likelihood of Treatment Recommendation (Patient-Reported Outcome) | Day 12 postpartum | Likelihood of recommending the treatment to others (categorized as likely/definitely recommend vs neutral or unlikely). |
Countries
Qatar
Outcome results
None listed