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NCT Number: NCT02055794

Promoting Optimal Healing After Laceration Repair 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.

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Key information

Conditions

Neuralgia, Perineal Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suturing of the perineal skin

Procedure

Closing perineal skin with surgical glue

Procedure

Other names: n-Butyl 2-cyanoacrylate, Indermil®, surgical glue

No suturing of the perineal skin

Procedure

Primary outcomes

  1. 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

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Promoting Optimal Healing After Laceration Repair Study - PALS Study

Acronym: PALS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2014
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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