Promoting Optimal Healing After Laceration Repair Study

Neuralgia, Perineal Clinical Trial

— PALS  

Official title:

Promoting Optimal Healing After Laceration Repair Study - PALS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055794
• Other study ID #: HUM00079230
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: October 4, 2017
• Start date: February 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lacerations
• Neuralgia
• Neuralgia, Perineal

Intervention

Procedure:
• Suturing of the perineal skin

• Closing perineal skin with surgical glue

• No suturing of the perineal skin

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-partum (PPD), 2 weeks, 6 weeks and 3 months.
Secondary	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).	6 weeks post-partum