Promoting Optimal Healing After Laceration Repair Study (PALS)

October 4, 2017 updated by: Dee Fenner, University of Michigan

Promoting Optimal Healing After Laceration Repair Study - PALS Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • The University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Suturing of the perineal skin
Active Comparator: 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.
Procedure: No suturing of the perineal skin
Active Comparator: 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.
Procedure: Closing perineal skin with surgical glue
Other Names:
  • n-Butyl 2-cyanoacrylate
  • Indermil®
  • surgical glue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-partum (PPD), 2 weeks, 6 weeks and 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound assessment
Time Frame: 6 weeks post-partum
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).
6 weeks post-partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Dee Fenner, M.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00079230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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