Wound Complication Clinical Trial
— PROVACOfficial title:
Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Verified date | September 2017 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | August 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Kinetic Concepts, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pain Scores | On postoperative day 2, all patients were administered a pain scale: Rank sharp pain (0-10), 10 being worst possible sharp pain. | Postpartum day 2 | |
Secondary | Tingling Pain Scores | On postoperative day 2, all patients were administered a pain scale: Rank tingling pain (0-10), 10 being worst possible tingling pain | Postpartum day 2 | |
Secondary | Postpartum Length of Stay | Until hospital discharge and then for 4 weeks follow up |
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