Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair

Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair: A Randomized Controlled Trial

To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire.

To assess maternal satisfaction with the laceration repair and suture material.

To assess overall perineal pain using a visual analog scale.

To assess the rate of wound breakdown and the need for suture removal.

Study Overview

• Status: Completed
• Conditions: Perineal Tear; Dyspareunia; Sutured Laceration
• Intervention / Treatment: Procedure: Laceration Repair with Polyglactin 910; Procedure: Laceration Repair with poliglecaprone 25

Detailed Description

This randomized controlled trial will be conducted and VCU medical center comparing 2 types of suture: rapidly absorbing polyglactin 910 (Vicryl Rapide) and poliglecaprone 25 (Monocryl) for first and second-degree lacerations requiring suture repair. Patients will be enrolled in the study immediately after vaginal delivery if a laceration occurs spontaneously. Patients will be randomized to one of the 2 sutures after enrollment.

Randomization will be obtained via computer generation in consecutively numbered, opaque sealed envelopes with the name of one of the suture materials. The envelope will be opened at the time of repair of perineal laceration once inclusion criteria have been met by the physician or midwife performing the laceration repair. Repair with the chosen suture will be performed using the continuous suture technique using a 3-0 suture, which is current standard practice. Patients will not be informed of the type of suture used, although the type of suture will be recorded in the patient's electronic medical record. Various maternal and fetal characteristics will be recorded including maternal age, gravity and parity, gestational age at delivery, birth weight, mode of vaginal delivery (spontaneous or operative).

Pain will be evaluated using a numeric pain scale at their 6 week postpartum visit and at 3 months postpartum via a telephone interview. At 3 months postpartum they will also be asked the following questions - Have you resumed sexual intercourse(yes/no)? How long after delivery was it before you resumed intercourse? Did you have pain the first time after delivery (yes/no)? Do you have continued dyspareunia (1-10)? Do you have residual perineal pain unrelated to intercourse? How satisfied are you with your laceration repair (very unsatisfied -1, neutral-3, very satisfied- 5). They will also be administered a 6 question validated Female Sexual Function Index.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• English speaking, patients with first and second degree spontaneous lacerations or those with midline or mediolateral epsiotomies that were uncomplicated, and hemodynamically stable paitents

Exclusion Criteria:

• non-english speaking, women without laceration or with more extensive third or fourth degree lacerations, and inmates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Polyglactin 910	Procedure: Laceration Repair with Polyglactin 910; Polyglactin 910 suture for laceration repair
ACTIVE_COMPARATOR: poliglecaprone 25	Procedure: Laceration Repair with poliglecaprone 25; poliglecaprone 25 suture for laceration repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Dyspareunia	To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire, with higher scores indicating greater discomfort or pain. Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome. The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain. A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse. A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse.	3 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Pain	To assess overall perineal pain using a visual analog scale on a range of 0-10, with 0 being no pain and 10 being worst imaginable pain Scale used - Pain Numeric Rating Scale. A minimal score of 0 indicates no pain whereas a maximums core of 10 indicates the worse imaginable pain.	6 weeks postpartum
Overall Sexual Function	Level of sexual desire or interest on a scale of 1-5, with 5 being the highest level of interest Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome. The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain. A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse. A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse.	3 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Ashley W Carroll, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2014
• Primary Completion (ACTUAL): August 27, 2017
• Study Completion (ACTUAL): August 27, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (ACTUAL): June 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Postpartum dyspareunia; Obestric laceration
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Lacerations; Dyspareunia
• Other Study ID Numbers: HM20000992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes