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Trial Outcomes & Findings for INSORB Versus Subcuticular Sutures at Cesarean Section (NCT NCT01687972)

NCT ID: NCT01687972

Last Updated: 2018-04-02

Results Overview

Visual Analog Score 0-10, with 0 being painless and 10 being the most severe

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

187 participants

Primary outcome timeframe

3 months

Results posted on

2018-04-02

Participant Flow

187 were consented, and 88 were randomized to intervention versus placebo.

Participant milestones

Participant milestones
Measure
Sutures
Absorbable sutures: placement of absorbable sutures at cesarean section
Insorb Staples
Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
Overall Study
STARTED
44
44
Overall Study
COMPLETED
44
44
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

INSORB Versus Subcuticular Sutures at Cesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sutures
n=44 Participants
Absorbable sutures: placement of absorbable sutures at cesarean section
Insorb Staples
n=44 Participants
Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
Total
n=88 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
44 Participants
n=99 Participants
44 Participants
n=107 Participants
88 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
44 Participants
n=99 Participants
44 Participants
n=107 Participants
88 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
44 participants
n=99 Participants
44 participants
n=107 Participants
88 participants
n=206 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Data was not collected for all participants enrolled due to failure to follow-up post intervention.

Visual Analog Score 0-10, with 0 being painless and 10 being the most severe

Outcome measures

Outcome measures
Measure
Sutures
n=19 Participants
Absorbable sutures: placement of absorbable sutures at cesarean section
Insorb Staples
n=16 Participants
Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
Patient Pain Scale
2.375 units on a scale
Interval 1.0 to 8.0
3.053 units on a scale
Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: 6 weeks

Population: Data was unable to be collected from all participants randomized due to lack of follow-up post intervention.

assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.

Outcome measures

Outcome measures
Measure
Sutures
n=2 Participants
Absorbable sutures: placement of absorbable sutures at cesarean section
Insorb Staples
n=1 Participants
Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
Patient Scar Assessment Scale (PSAS)
20 units on a scale
Interval 11.0 to 29.0
13 units on a scale
Interval 13.0 to 13.0

PRIMARY outcome

Timeframe: up to 20 minutes post intervention

Population: Data was not collected for all participants enrolled

Number of minutes taken to close post cesarean section

Outcome measures

Outcome measures
Measure
Sutures
n=33 Participants
Absorbable sutures: placement of absorbable sutures at cesarean section
Insorb Staples
n=31 Participants
Insorb absorbable staples: Placement of Insorb absorbable staples at cesarean section
Closure Time
4.161 minutes
Interval 1.0 to 8.0
9.79 minutes
Interval 1.0 to 16.0

Adverse Events

Sutures

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

Insorb Staples

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

Janice Henderson, MD Assistant Professor

Johns Hopkins Univesity School of Medicine

Phone: 443-287-2783

Results disclosure agreements

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