Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy

Study Overview
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Brief Summary
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Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.

Official Title
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Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.

Conditions
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Mediolateral Episiotomy After Delivery

Intervention / Treatment
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* Procedure: octyl-2-cyanoacrylate adhesive glue
* Procedure: Subcuticular suture of perineal skin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vaginal delivery episiotomy performed no further perineal or vaginal lesions present Exclusion Criteria: previously existing local infections or lesions body mass index > 35 (Kg/m2) severe pulmonary disease collagen disease known immunodeficiency diabetes mellitus immunosuppressive treatment
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin adhesive<br>perineal skin repair with octyl-2-cyanoacrylate skin adhesive | Procedure: octyl-2-cyanoacrylate adhesive glue<br>* use of octyl-2-cyanoacrylate adhesive glue for perineal skin repair after episiotomy<br>* Other names: Dermabond;|
| Active Comparator: subcuticular suture<br>continuous subcuticular suture of perineal skin using rapidly absorbable polyglactin 910 | Procedure: Subcuticular suture of perineal skin<br>* Use of continuous subcuticular suture with rapidly absorbable polyglactin 910 for closure of the perineal skin in episiotomy repair<br>* Other names: Vicryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-assessed perineal pain |  | First 30 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time spent with repair of episiotomy |  | within 1 hour after birth | 
| Pain during procedure |  | within 1 hour after birth | 
| Difficulties reported during procedure |  | within 1 hour after birth | 
| Number of sutures and adhesive devices used |  | within 1 hour after birth | 
| Wound complications |  | 42-68 hours after delivery | 
| Need to seek health facilities |  | 30 days after delivery | 
| Return of sexual activity |  | 30 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin adhesive, tissue adhesive, mediolateral episiotomy, perineal repair, labor and delivery, repair