PROphylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
PROVAC
Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
1 other identifier
interventional
136
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedResults Posted
Study results publicly available
October 13, 2017
CompletedOctober 13, 2017
September 1, 2017
2.1 years
April 29, 2014
July 10, 2017
September 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Wound Complications
The primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening
Four weeks after cesarean section
Secondary Outcomes (3)
Pain Scores
Postpartum day 2
Tingling Pain Scores
Postpartum day 2
Postpartum Length of Stay
Until hospital discharge and then for 4 weeks follow up
Study Arms (2)
Closed Incision Wound vacuum (Prevena)
EXPERIMENTALClosed incision wound vacuum (Prevena)
Routine Wound Care
NO INTERVENTIONThis arm includes patients having a cesarean section with routine wound care
Interventions
wound vacuum to be placed on a closed incision
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Kinetic Concepts, Inc.collaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Ruhstaller K, Downes KL, Chandrasekaran S, Srinivas S, Durnwald C. Prophylactic Wound Vacuum Therapy after Cesarean Section to Prevent Wound Complications in the Obese Population: A Randomized Controlled Trial (the ProVac Study). Am J Perinatol. 2017 Sep;34(11):1125-1130. doi: 10.1055/s-0037-1604161. Epub 2017 Jul 13.
PMID: 28704847DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Valerie Riis
- Organization
- UPENN
Study Officials
- PRINCIPAL INVESTIGATOR
Celeste Durnwald, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2014
First Posted
May 1, 2014
Study Start
May 1, 2014
Primary Completion
June 1, 2016
Study Completion
August 1, 2017
Last Updated
October 13, 2017
Results First Posted
October 13, 2017
Record last verified: 2017-09