Promoting Optimal Healing After Laceration Repair Study

Completed · Not applicable

Conditions studied: Neuralgia, Perineal

In brief

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.

Key facts

Study ID

NCT02055794

Run by

University of Michigan

People needed

35

Starts

2014-02-01

Expected to finish

2017-09-01

Last updated by the study team

2017-10-05

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• <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

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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