Promoting Optimal Healing After Laceration Repair Study - PALS Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Patient-perceived pain
Study Overview
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 :
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Suturing of the perineal skin (Procedure)
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.
Intervention: No suturing of the perineal skin (Procedure)
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.
Intervention: Closing perineal skin with surgical glue (Procedure)
Outcomes
Primary Outcomes
Patient-perceived pain
Time Frame: Post-partum (PPD), 2 weeks, 6 weeks and 3 months.
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.
Secondary Outcomes
- Wound assessment(6 weeks post-partum)
Investigators
Dee Fenner
Professor, Obstetrics & Gynecology
University of Michigan