Assess the Efficacy of Prevena Plus vs SOC to Closed Incision in Pts Undergoing CAWR and Other Laparotomy Procedures.

NCT04539015 | Unknown

• 1 other identifier: 14072
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• surgical site infection

  wound infection, seroma and wound dehiscence.

  30 days

Secondary Outcomes (1)

• Hospital Admissions

  30 days

Study Arms (2)

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.

Device: Prevena Plus

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 DEVICE

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

Group-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are scheduled and or admitted at Westchester Medical Center to undergo complex abdominal wall reconstruction with Biomesh and other major laparotomies will be identified by the study staff

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.
• Subject meets below criteria are eligible for randomization:
• 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.
• Subject who meets below intra operative criteria are considered as screen failures and are not eligible for randomization:
• 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.

Sponsors & Collaborators

• New York Medical College: lead
• Acelity: collaborator

Study Sites (1)

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Rifat Latifi, MD

  Chairman Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agon Kajmolli, MD

CONTACT

9144937936; agon.kajmolli@wmchealth.org

Matthew McGuirk, MD

CONTACT

9144937936; Matthew.McGuirk@wmchealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, General surgery

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: September 4, 2020
• Study Start: July 9, 2020
• Primary Completion: December 30, 2022
• Study Completion: February 28, 2023
• Last Updated: September 4, 2020

Record last verified: 2020-08

Locations

US (1)