Trial Outcomes & Findings for Negative Pressure Wound Therapy After Cesarean Delivery (NCT NCT01637870)

NCT ID: NCT01637870

Last Updated: 2018-04-18

Results Overview

Wound infection, separation or deep infection

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: Up to 6 weeks from time of surgery
• Results posted on: 2018-04-18

Participant Flow

Participant milestones

Measure	Negative Pressure Pump Will have the Prevena negative pressure wound system placed at the time of surgery.
Overall Study STARTED	110
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Negative Pressure Wound Therapy After Cesarean Delivery

Baseline characteristics by cohort

Measure	Negative Pressure Pump n=110 Participants Will have the Prevena negative pressure wound system placed at the time of surgery.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	110 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.8 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks from time of surgery

Wound infection, separation or deep infection

Outcome measures

Measure	Negative Pressure Pump n=110 Participants Will have the Prevena negative pressure wound system placed at the time of surgery.
Wound Complication Rate Endometritis	1 participants
Wound Complication Rate Wound separation	3 participants
Wound Complication Rate All wound complications (separation and infection)	6 participants
Wound Complication Rate wound infection	3 participants

Adverse Events

Negative Pressure Pump

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Negative Pressure Pump n=110 participants at risk Will have the Prevena negative pressure wound system placed at the time of surgery. Prevena negative pressure wound system: Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
Skin and subcutaneous tissue disorders Skin irritation	0.91% 1/110

Other adverse events

Adverse event data not reported

Additional Information

Abbey Hardy-Fairbanks, MD

University of Iowa Hospitals and Clinics

Phone: 319-356-2291

Email: abbey-hardy-fairbanks@uiowa.edu

Results disclosure agreements

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