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Trial Outcomes & Findings for Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair (NCT NCT03184077)

NCT ID: NCT03184077

Last Updated: 2019-08-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

318 participants

Primary outcome timeframe

3 months postpartum

Results posted on

2019-08-28

Participant Flow

Participant milestones

Participant milestones
Measure
Polyglactic 910 (Vicryl Rapide)
Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair
Monocryl
Laceration Repair with Monocryl: Monocryl suture for laceration repair
Overall Study
STARTED
166
152
Overall Study
COMPLETED
145
131
Overall Study
NOT COMPLETED
21
21

Reasons for withdrawal

Reasons for withdrawal
Measure
Polyglactic 910 (Vicryl Rapide)
Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair
Monocryl
Laceration Repair with Monocryl: Monocryl suture for laceration repair
Overall Study
Lost to Follow-up
21
21

Baseline Characteristics

Rapidly Absorbing Polyglactin 910 Versus Poliglecaprone 25 for Laceration Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Polyglactic 910 (Vicryl Rapide)
n=145 Participants
Laceration Repair with Polyglactic 910 (Vicryl Rapide): Polyglactic 910 suture for laceration repair
Monocryl
n=131 Participants
Laceration Repair with Monocryl: Monocryl suture for laceration repair
Total
n=276 Participants
Total of all reporting groups
Age, Continuous
27.4 years
n=93 Participants
27.6 years
n=4 Participants
27.4 years
n=27 Participants
Sex: Female, Male
Female
145 Participants
n=93 Participants
131 Participants
n=4 Participants
276 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race/Ethnicity, Customized
Black or African American
63 Participants
n=93 Participants
51 Participants
n=4 Participants
114 Participants
n=27 Participants
Race/Ethnicity, Customized
White
60 Participants
n=93 Participants
62 Participants
n=4 Participants
122 Participants
n=27 Participants
Race/Ethnicity, Customized
Asian
4 Participants
n=93 Participants
5 Participants
n=4 Participants
9 Participants
n=27 Participants
Race/Ethnicity, Customized
Hispanic or Latino
6 Participants
n=93 Participants
1 Participants
n=4 Participants
7 Participants
n=27 Participants
Race/Ethnicity, Customized
Other
12 Participants
n=93 Participants
12 Participants
n=4 Participants
24 Participants
n=27 Participants
Region of Enrollment
United States
145 participants
n=93 Participants
131 participants
n=4 Participants
318 participants
n=27 Participants

PRIMARY outcome

Timeframe: 3 months postpartum

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.

Outcome measures

Outcome measures
Measure
Polyglactin 910 (Vicryl Rapide)
n=145 Participants
Laceration Repair with Polyglactin 910 (Vicryl Rapide): Polyglactin 910 suture for laceration repair
Poliglecaprone 25
n=131 Participants
Laceration Repair with poliglecaprone 25: poliglecaprone 25 suture for laceration repair
Rates of Dyspareunia
3.6 units on a scale
Standard Deviation 1.4
3.49 units on a scale
Standard Deviation 1.47

SECONDARY outcome

Timeframe: 6 weeks postpartum

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.

Outcome measures

Outcome measures
Measure
Polyglactin 910 (Vicryl Rapide)
n=145 Participants
Laceration Repair with Polyglactin 910 (Vicryl Rapide): Polyglactin 910 suture for laceration repair
Poliglecaprone 25
n=131 Participants
Laceration Repair with poliglecaprone 25: poliglecaprone 25 suture for laceration repair
Postpartum Pain
.85 units on a scale
Standard Deviation 1.67
.83 units on a scale
Standard Deviation 1.62

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure
Polyglactin 910 (Vicryl Rapide)
n=145 Participants
Laceration Repair with Polyglactin 910 (Vicryl Rapide): Polyglactin 910 suture for laceration repair
Poliglecaprone 25
n=131 Participants
Laceration Repair with poliglecaprone 25: poliglecaprone 25 suture for laceration repair
Overall Sexual Function
2.87 units on a scale
Standard Deviation 1.4
2.51 units on a scale
Standard Deviation 1.47

Adverse Events

Polyglactic 910 (Vicryl Rapide)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Monocryl

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lindsay Morrell, MD

Virginia Commonwealth University

Phone: 410-823-1120

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place