Promoting Optimal Healing After Laceration Repair Study
NCT ID: NCT02055794
Last Updated: 2017-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2014-02-28
2017-09-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Suturing of the perineal skin
Suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.
Suturing of the perineal skin
No suturing of the perineal skin
No suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.
No suturing of the perineal skin
Closing perineal skin with surgical glue
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.
Closing perineal skin with surgical glue
Interventions
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Suturing of the perineal skin
Closing perineal skin with surgical glue
No suturing of the perineal skin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Dee Fenner
Professor, Obstetrics & Gynecology
Principal Investigators
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Dee Fenner, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00079230
Identifier Type: -
Identifier Source: org_study_id