Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
Completed · Phase 4
Conditions studied: High Risk Abdominal Wounds
In brief
The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs). Hypothesis: Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce these rates by 50%.
Key facts
- Study ID
- NCT02137447
- Run by
- Massachusetts General Hospital
- People needed
- 10
- Starts
- 2014-05-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2017-04-18
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All five of the following criteria must be present for enrollment into the study:
- Signed written informed consent must be provided by the patient or by patient's legally acceptable representative, if patient unable to consent.
- Age > 18 years
- Abdominal operation entering the peritoneal cavity under general anesthesia for colostomy or ileostomy reversal or enterocutaneous fistula excision
- Clean - contaminated OR contaminated OR dirty wound (as defined by Wound Infection Surveillance) OR use of skin flaps for skin closure.
- Complete closure of the surgical wound including the skin.
You may not qualify if…
- 1) Known allergic reaction at the wound dressing parts of the Prevena ™ Incision Management System.
- (Included but not limited to: sensitivity to silver, allergic or hypersensitivity reaction to acrylic adhesives).
- Inability to close the abdominal wall at the index procedure. 3) Inability to close the skin at the index procedure. 4) Patients under 18 years old. 5) Pregnant women test
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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