Trial Outcomes & Findings for Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy (NCT NCT00654641)

Results Overview

Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

6 Weeks post-partum

Results posted on

2013-01-30

Participant milestones
Measure	Negative Pressure Wound Closure Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.	Standard Wound Closure Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
Overall Study STARTED	28	26
Overall Study COMPLETED	26	23
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal
Measure	Negative Pressure Wound Closure Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.	Standard Wound Closure Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
Overall Study Lost to Follow-up	2	3

Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Baseline characteristics by cohort
Measure	Negative Pressure Wound Closure n=28 Participants Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.	Standard Wound Closure n=26 Participants Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.	Total n=54 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	28 Participants n=99 Participants	26 Participants n=107 Participants	54 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	28 Participants n=99 Participants	26 Participants n=107 Participants	54 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	28 participants n=99 Participants	26 participants n=107 Participants	54 participants n=206 Participants

Timeframe: 6 Weeks post-partum

Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.

Outcome measures
Measure	Negative Pressure Wound Closure n=28 Participants Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.	Standard Wound Closure n=26 Participants Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
Total Number of Patients Experiencing a Wound Complication	15 Participants	10 Participants

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Negative Pressure Wound Closure n=28 participants at risk Negative Pressure wound closure utilizing wall suction and a drain placed exterior to the closed wound.	Standard Wound Closure n=26 participants at risk Wound closed in standard fashion utilizing subcutaneous absorb-able suture and skin staples.
Skin and subcutaneous tissue disorders Wound complication	53.6% 15/28 • Number of events 15	38.5% 10/26 • Number of events 10

West Viginia University

Phone: 304-293-1566