Clinical trial NCT02055794: Promoting Optimal Healing After Laceration Repair Study
Official title: Promoting Optimal Healing After Laceration Repair Study - PALS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgia, Perineal
Keywords: perineal wound
perineal tear
perineum
pain
childbirth
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-perceived pain
timeFrame: Post-partum (PPD), 2 weeks, 6 weeks and 3 months.
Secondary outcomes:
measure: Wound assessment
timeFrame: 6 weeks post-partum
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Dee Fenner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: