N/A N=441 Randomized Treatment

Negative Pressure Wound Therapy in Cesarean Section

Postoperative Wound Complications

Bottom Line

View on ClinicalTrials.gov: NCT02289157 ↗

Enrolled (actual)

441

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Number of Participants With Wound Complication — 37; 42 Participants — p=0.54

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Negative pressure wound therapy (Device)
Age: Pediatric, Adult · 10+ yrs
Sex: Female
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Wound Complication	37; 42	0.54
PRIMARY Number of Participants With Classification of Wound Morbidity	4; 1; 12; 16; 20; 25	0.31
SECONDARY Length of Postoperative Stay	3; 3	0.54
SECONDARY Length of Stay After Readmission	16; 21	0.41
SECONDARY Number of Patients With Emergency Room Visits After Discharge	190; 190; 30; 28; 2; 1	0.38
SECONDARY Number of Patients With Number of Clinic Visits	15; 15; 4; 6; 5; 2	0.48
SECONDARY Number of Participants With Morbid Outcomes After Delivery	12; 9; 33; 39; 14; 10	0.52
SECONDARY Number of Participants With Scheduled and Unscheduled Cesarean Section	12; 12; 25; 30	0.68
SECONDARY Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section	3; 8; 34; 34	0.27
SECONDARY Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section	15; 17; 22; 25	0.55
SECONDARY Number of Patients in Labor Versus no Labor Prior to Cesarean Section	15; 17; 22; 25	0.49
SECONDARY Number of Patients With Hypertension Versus no Hypertension	8; 8; 29; 34	0.92
SECONDARY Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes	5; 7; 32; 35	0.22
SECONDARY Number of Patients With Chorioamnionitis Versus no Chorioamnionitis	4; 3; 33; 39	0.74

Summary

The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .

Eligibility Criteria

Inclusion Criteria

Pregnant women with BMI > 40 undergoing a cesarean delivery at Parkland Health and Hospital System.

Exclusion Criteria

Any patient not meeting inclusion criteria will be deemed ineligible.
All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
according to the wound therapy manufacturer's instructions patients with:
fragile skin
allergy to silver or acrylic adhesives
a malignancy in the wound bed or margins of the wound bed
non-enteric and unexplored fistulas
necrotic tissue with eschar present
exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02289157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.