Recruiting

Prevena Plus vs. SOC

Sponsor:

New York Medical College

Code:

NCT04539015

Conditions

Hernia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prevena Plus

Study Details

Brief summary:

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.

Conditions

Hernia

Study ID

NCT04539015

Start date

Jul 9, 2020

Status verified date

Aug, 2020

Completion date

Feb 28, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

170 participants

Anticipated

Interventions and Outcome Measures

Arms

Group-I

Patients randomized to the Group-I will receive PREVENA Plus, which is currently being used at our institution (Prevena, KCI) and it is FDA-approved device. Dressings will be applied under sterile conditions at the end of the surgery while still in the operating room and will continuously apply for 5 days.

Group-II

Subjects randomized to SOC surgical incision dressing arm will receive SOC dressing for 4 days immediately following surgery. The closed incision will be covered with materials which may include sterile gauze pieces, surgical tape and tegaderm.

Any material used for the SOC dressing will be documented.

Interventions

Prevena Plus

PREVENA Plus is a negative pressure wound therapy device intended for use on surgical incisions that continue to drain following sutured or stapled closures.

Primary outcome measure

  • surgical site infection [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Agon Kajmolli, MD

9144937936agon.kajmolli@wmchealth.org

Matthew McGuirk, MD

9144937936Matthew.McGuirk@wmchealth.org

Locations

Westchester Medical Center

Recruiting

Valhalla, New York, United States, 10595

Contacts

Agon Kajmolli, MD

914-493-7936agon.kajmolli@wmchealth.org

Matthew McGuirk, MD

9144937936Matthew.McGuirk@wmchealth.org

More Information

Sponsor

New York Medical College

Last update posted

Sep 4, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Medical College on 2020-09-04.