Promoting Optimal Healing After Laceration Repair Study

N/ACompletedNCT02055794

University of Michigan35 enrolled

Overview

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.

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 : 1. Closure of the deep tissues and superficial perineal skin using a continuous 3-0 Vicryl suture 2. 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: 1. Perineal skin closure with suturing 2. Not suturing the perineal skin 3. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neuralgia, Perineal

Interventions

Suturing of the perineal skinPROCEDURE

Closing perineal skin with surgical gluePROCEDURE

No suturing of the perineal skinPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: Post-partum (PPD), 2 weeks, 6 weeks and 3 months.

Secondary Outcomes

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).

Time frame: 6 weeks post-partum

Data from ClinicalTrials.gov

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