Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02055794
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Optimal Healing After Laceration Repair Study
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Promoting Optimal Healing After Laceration Repair Study - PALS Study
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALS
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: