Trial Outcomes & Findings for Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients (NCT NCT03082664)

NCT ID: NCT03082664

Last Updated: 2022-09-26

Results Overview

Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 154 participants
• Primary outcome timeframe: post operative day 1-42
• Results posted on: 2022-09-26

Participant Flow

Participant milestones

Measure	Standard Dressing Standard dressing will be applied after C-section.	PICO Dressing Device: PICO Single Use Negative Pressure Wound Therapy PICO Single Use Negative Pressure Wound Therapy: The PICO device will be placed over the closed cesarean section incision.
Overall Study STARTED	75	79
Overall Study COMPLETED	75	79
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients

Baseline characteristics by cohort

Measure	Standard Dressing n=75 Participants Standard dressing will be applied after C-section.	PICO Dressing n=79 Participants Device: PICO Single Use Negative Pressure Wound Therapy PICO Single Use Negative Pressure Wound Therapy: The PICO device will be placed over the closed cesarean section incision.	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	79 Participants n=7 Participants	154 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.9 years STANDARD_DEVIATION 6.5 • n=5 Participants	30.5 years STANDARD_DEVIATION 6.1 • n=7 Participants	31.2 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	79 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	64 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	79 participants n=7 Participants	154 participants n=5 Participants

PRIMARY outcome

Timeframe: post operative day 1-42

Population: Participants who had any follow up at either 1, 2 or 6 weeks were included.

Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence

Outcome measures

Measure	Standard Dressing n=67 Participants Standard dressing will be applied after C-section.	PICO Dressing n=71 Participants Device: PICO Single Use Negative Pressure Wound Therapy PICO Single Use Negative Pressure Wound Therapy: The PICO device will be placed over the closed cesarean section incision.
Wound Complication	13 Participants	14 Participants

Adverse Events

Standard Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PICO Dressing

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

Dr. Maritza G. Gonzalez

University of Chicago

Phone: 7737026118

Email: mggonzalez@bsd.uchicago.edu

Results disclosure agreements

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