Clinical trial NCT03184077: Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair
Official title: Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspareunia
Perineal Tear
Sutured Laceration
Keywords: Postpartum dyspareunia
Obestric laceration
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 318
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rates of Dyspareunia
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Postpartum Pain
timeFrame: 6 weeks postpartum
measure: Overall Sexual Function
timeFrame: 3 months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ashley W Carroll, MD
role: PRINCIPAL_INVESTIGATOR
References: