N/A
N=318
Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
Dyspareunia · Perineal Tear · Sutured Laceration
Bottom Line
View on ClinicalTrials.gov: NCT03184077 ↗Enrolled (actual)
318
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Rates of Dyspareunia — 3.6; 3.49 units on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laceration Repair with Polyglactin 910 (Procedure); Laceration Repair with poliglecaprone 25 (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Dyspareunia |
3.6; 3.49 | 0.16 |
| SECONDARY Postpartum Pain |
.85; .83 | 0.62 |
| SECONDARY Overall Sexual Function |
2.87; 2.51 | 0.01 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03184077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.