Phase 4
N=10
Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions
High Risk Abdominal Wounds
Bottom Line
View on ClinicalTrials.gov: NCT02137447 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Negative Pressure treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation |
1 | — |
| SECONDARY Composite Secondary Outcomes of Non-infectious Abdominal Wound Complications, Damage to the Skin Caused by the Dressing, Need to End the Treatment Prior to Discharge or Prior to 5-7 Post-operative Days, and Need for Reapplication of the System. |
— | — |
Summary
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%.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02137447). 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.