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N/A N=136 Randomized Treatment

PROphylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population

Wound Complication

Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Number of Participants With Wound Complications — 3; 4 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Closed incision wound vacuum (Prevena) (Device)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Pennsylvania
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Wound Complications
3; 4
SECONDARY
Pain Scores
6; 5.5
SECONDARY
Tingling Pain Scores
2; 1.5
SECONDARY
Postpartum Length of Stay
3; 3

Summary

This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed incisions decreases the risk of wound complications among obese patients after cesarean section All patients having a cesarean section in labor or presenting to the triage unit and requiring a cesarean section will be eligible Main study intervention: this involves the use of a negative pressure wound vacuum therapy on a closed incision.

Eligibility Criteria

Key inclusion criteria BMI greater than or equal to 30 kg/m2 at less than or equal to 22 weeks of gestation Subject is laboring Subject is having an unplanned cesarean section Subject will have Pfannenstiel Skin Incision Subject has the ability to take a picture and email it to a secure account Subject receives prenatal care in the University of Pennsylvania health system and plans to follow up postpartum in the system Subject is greater than or equal to 18 years of age Key exclusion criteria Subject cannot read or speak English Subject is not 18 years of age Subject does not have ability to send a picture by email Subject has preexisting diabetes mellitus (Type 1 or Type 2) , is using chronic steroids or immune-suppressants, OR being actively treated for a malignancy Subject is undergoing a scheduled cesarean section Subject is allergic to silver
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02128997). 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.

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