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Promoting Optimal Healing After Laceration Repair Study (PALS)

Primary Purpose

Neuralgia, Perineal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suturing of the perineal skin
Closing perineal skin with surgical glue
No suturing of the perineal skin
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia, Perineal focused on measuring perineal wound, perineal tear, perineum, pain, childbirth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Suturing of the perineal skin

No suturing of the perineal skin

Closing perineal skin with surgical glue

Arm Description

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 after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.

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.

Outcomes

Primary Outcome Measures

Patient-perceived pain
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 Outcome Measures

Wound assessment
Wounds will be assessed through wound evaluation (6 weeks post-partum), wound complications (wound infection, dehiscence, granulation tissue), need for additional interventions (silver nitrate, revision of wound) and assessment of wound appearance using a validated 100-mm VAS (anchors: 0 = worst scar, 100 mm = best scar).

Full Information

First Posted
February 4, 2014
Last Updated
October 4, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02055794
Brief Title
Promoting Optimal Healing After Laceration Repair Study
Acronym
PALS
Official Title
Promoting Optimal Healing After Laceration Repair Study - PALS Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. Aim: To assess and compare patient pain among the three groups at intervals of 1 day, 2 weeks, 6 weeks and 3 months postpartum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Perineal
Keywords
perineal wound, perineal tear, perineum, pain, childbirth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suturing of the perineal skin
Arm Type
Active Comparator
Arm Description
Suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.
Arm Title
No suturing of the perineal skin
Arm Type
Active Comparator
Arm Description
No suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.
Arm Title
Closing perineal skin with surgical glue
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Suturing of the perineal skin
Intervention Type
Procedure
Intervention Name(s)
Closing perineal skin with surgical glue
Other Intervention Name(s)
n-Butyl 2-cyanoacrylate, Indermil®, surgical glue
Intervention Type
Procedure
Intervention Name(s)
No suturing of the perineal skin
Primary Outcome Measure Information:
Title
Patient-perceived pain
Description
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.
Time Frame
Post-partum (PPD), 2 weeks, 6 weeks and 3 months.
Secondary Outcome Measure Information:
Title
Wound assessment
Description
Wounds will be assessed through wound evaluation (6 weeks post-partum), wound complications (wound infection, dehiscence, granulation tissue), need for additional interventions (silver nitrate, revision of wound) and assessment of wound appearance using a validated 100-mm VAS (anchors: 0 = worst scar, 100 mm = best scar).
Time Frame
6 weeks post-partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dee Fenner, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Promoting Optimal Healing After Laceration Repair Study

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