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Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair

NCT03184077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2019-08-28

Study results available
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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.

Conditions

  • Dyspareunia
  • Perineal Tear
  • Sutured Laceration

Interventions

PROCEDURE

Laceration Repair with Polyglactin 910

Polyglactin 910 suture for laceration repair

PROCEDURE

Laceration Repair with poliglecaprone 25

poliglecaprone 25 suture for laceration repair

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ashley W Carroll, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-02
Primary Completion
2017-08-27
Completion
2017-08-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03184077 on ClinicalTrials.gov