Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair

Dyspareunia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184077
• Other study ID #: HM20000992
• Status: Completed
• Phase: N/A
• Start date: September 2, 2014
• Est. completion date: August 27, 2017

Study information

• Verified date: August 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: August 27, 2017
• Est. primary completion date: August 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspareunia
• Lacerations
• Perineal Tear
• Sutured Laceration

Intervention

Procedure:
• Laceration Repair with Polyglactin 910
Polyglactin 910 suture for laceration repair
• Laceration Repair with poliglecaprone 25
poliglecaprone 25 suture for laceration repair

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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