Promoting Optimal Healing After Laceration Repair Study

Study Overview
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Brief Summary
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The goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain. Null hypothesis: There will be no difference in patient pain among the three different methods for second degree perineal wound repair.

Detailed Description
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At the University of Michigan, there are currently two standard techniques for repairing second-degree perineal lacerations that differ only in management of the perineal skin : Closure of the deep tissues and superficial perineal skin using a continuous 3-0 Vicryl suture Closure of the deep tissues with a continuous 3-0 Vicryl suture and reapproximation of, but not suture-closure of the perineal skin. The primary goal of our study is to compare patient pain amongst the following three perineal skin repair techniques after second degree laceration: Perineal skin closure with suturing Not suturing the perineal skin Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue. In all women, the deep vaginal and perineal tissues will be closed using a continuous 3-0 Vicryl suture, as is current standard practice. Aim: To assess and compare patient pain among the three groups at intervals of 1 day, 2 weeks, 6 weeks and 3 months postpartum.

Official Title
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Promoting Optimal Healing After Laceration Repair Study - PALS Study

Conditions
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Neuralgia, Perineal

Intervention / Treatment
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* Procedure: Suturing of the perineal skin
* Procedure: Closing perineal skin with surgical glue
* Procedure: No suturing of the perineal skin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years old - 45 years old Immediately post-vaginal birth, including forceps-assisted vaginal delivery, vacuum-assisted vaginal delivery > 32 weeks gestation Second degree laceration from spontaneous tear or midline episiotomy Proficient in English Exclusion Criteria: <18 years old and >45 years old Delivery by Cesarean 1st, 3rd or 4th degree lacerations Induction for intrauterine fetal demise or terminal fetal condition, or any instance where immediate status of the newborn is unknown Known allergy to cyanoacrylate or formaldehyde Systemic infections, uncontrolled diabetes (women with well-controlled pre-gestational or gestational diabetes will not be excluded) History of connective tissue disorders (e.g. Scleroderma, Ehlers Danlos) Chronic use of steroids Currently under treatment for cancer Previous radiation to the pelvis Any organ transplants History of neurological conditions including multiple sclerosis, stroke, Alzheimer's, or other dementias Not proficient in the English language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suturing of the perineal skin<br>Suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. | Procedure: Suturing of the perineal skin<br> <br> |
| Active Comparator: No suturing of the perineal skin<br>No suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. | Procedure: No suturing of the perineal skin<br> <br> |
| Active Comparator: Closing perineal skin with surgical glue<br>Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. | Procedure: Closing perineal skin with surgical glue<br> <br> * Other names: surgical glue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-perceived pain | The 2 week and 3 month measurements will be done via email, web or mailed questionnaire. Pain will be measured using 3 pain scales: a validated 100-mm Visual Analogue Scale (VAS) (anchors: 0 = none, 100 mm = worst imaginable), a 6 point Likert scale and the McGill pain questionnaire short form. | Post-partum (PPD), 2 weeks, 6 weeks and 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound assessment | Wounds will be assessed through wound evaluation (6 weeks post-partum), wound complications (wound infection, dehiscence, granulation tissue), need for additional interventions (silver nitrate, revision of wound) and assessment of wound appearance using a validated 100-mm VAS (anchors: 0 = worst scar, 100 mm = best scar). | 6 weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal wound, perineal tear, perineum, pain, childbirth