Assess the Efficacy of Prevena Plus vs SOC to Closed Incision in Pts Undergoing CAWR and Other Laparotomy Procedures.
Status unconfirmed
Conditions studied: Hernia
In brief
The goal of this study to establish the efficacy of Prevena™ Plus in preventing surgical site infection after complex abdominal wall procedures and major laparotomies as compared to SOC dressing. We hypothesized that use of Prevena Plus will significantly decrease the incidence of Surgical Site Infection (SSI) and subsequently may have an impact over reducing hospital cost. Study data will be analyzed for clinical outcomes through 30 days. The patients will be followed every day during the hospital stay and study follow-up visits will be conducted in the clinic at 2 weeks and 1 month from the date of discharge.
Key facts
- Study ID
- NCT04539015
- Run by
- New York Medical College
- People needed
- 170
- Starts
- 2020-07-09
- Expected to finish
- 2023-02-28
- Last updated by the study team
- 2020-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or Female, 18 years of age or older
- Open abdominal wall reconstruction with biological mesh, elective colorectal procedures, solid organ tumor resection, liver transplant and elective bowel resections.
- Surgical incision closed with staplers or sutures.
- Able to provide informed consent
- Willing and able to return for scheduled study visits
- Female of child bearing age, must be negative on urine pregnancy test.
- Center for disease control (CDC) wound class I and II.
- Intra-operative inclusion criteria:
- Subject meets below criteria are eligible for randomization:
- Subject continues to meet all pre-operative inclusion criteria
- Has been classified as CDC wound Class I or II resulting in a closed surgical incision and will be able to cover the surgical incision by Prevena Plus
You may not qualify if…
- Age less than 18 years
- Wound left to close by secondary intention.
- Open wounds or dehisced wounds.
- Patient has known allergy or hypersensitivity to silver or adhesive tape material (acrylic compounds).
- Patients having known systemic bacterial or fungal infection at the time of surgery and local SSI before surgery. (Untreated or inadequately treated infection)
- Inadequate hemostasis of the incision
- Cellulitis of the incision area
- Subject who, in the investigator's opinion, would have any clinically significant condition that would impair his/her ability to comply with the study procedures
- Laparoscopic surgery.
- Patients undergoing perforation or diverticulitis will be excluded from the study.
- Intra-operative inclusion criteria:
- Subject who meets below intra operative criteria are considered as screen failures and are not eligible for randomization:
- If Subject meets any of the above exclusion criteria
- Subject determined to have Class III or IV wound classification procedure like open, fresh, accidental wounds, and /or major breaks in sterile technique or gross spillage from GI tract or old traumatic wounds retained devitalized tissue and those that involve existing clinical infection or perforated viscera.
- Patients who have very fragile skin around the incision are not included in the study
- If patients have any known bleeding disorders or if they refuse blood transfusions.
Where it is running
- Westchester Medical Center — Valhalla, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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