Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair

NCT ID: NCT03184077

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 318 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-02
• Study Completion Date: 2017-08-27

Brief Summary

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.

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.

Conditions

Dyspareunia; Perineal Tear; Sutured Laceration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Polyglactin 910

Group Type: ACTIVE_COMPARATOR

Laceration Repair with Polyglactin 910

Intervention Type: PROCEDURE

Polyglactin 910 suture for laceration repair

poliglecaprone 25

Group Type: ACTIVE_COMPARATOR

Laceration Repair with poliglecaprone 25

Intervention Type: PROCEDURE

poliglecaprone 25 suture for laceration repair

Interventions

Laceration Repair with Polyglactin 910

Polyglactin 910 suture for laceration repair

Intervention Type: PROCEDURE

Laceration Repair with poliglecaprone 25

poliglecaprone 25 suture for laceration repair

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley W Carroll, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HM20000992

Identifier Type: -

Identifier Source: org_study_id