The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects

NCT01341444 | Terminated Results

• 1 other identifier: AHS.2012.Prevena.Cooper.01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy. Prevena will be tested while applied during the time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small portable negative pressure device which consists of a therapy unit that delivers negative pressure. It also includes a dressing system that is intended for use over closed incisions after surgery. The intent of this study is to evaluate Prevena versus the standard care that a doctor would use normally after a kidney transplant.

Conditions

Surgical Site Reaction

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Surgical Site Complications (SSCs)

  The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.

  62 Days

Study Arms (2)

Prevena Incision Management System

EXPERIMENTAL

Negative Pressure Therapy Device

Device: Prevena Incision Management System

Standard of Care for Surgical Incisions

PLACEBO COMPARATOR

Sterile gauze and a non-penetrable barrier

Other: Standard of Care for Surgical Incisions

Interventions

Prevena Incision Management System DEVICE

It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).

Prevena Incision Management System

Standard of Care for Surgical Incisions OTHER

Sterile 4X4 Non-Penetrable barrier

Standard of Care for Surgical Incisions

Eligibility Criteria

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

You may qualify if:

• The Subject:
• is an adult ≥ 18 years old of either gender
• is able to provide their own informed consent Protocol: AHS.2012.Prevena.Cooper.01 v 4.0 Confidential/Property of KCI USA, Inc. Page 6 of 71
• will undergo open renal transplant surgery within the next 30 days
• will require a surgical incision able to be covered completely by the PIMS dressing
• is pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
• Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered
• \- OR -
• Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination
• is willing and able to return for all scheduled and required study visits
• if female, must test negative on serum pregnancy test
• if a female of child-bearing potential, must be willing to utilize an acceptable method of birth control (e.g., birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc.) for the duration of study participation
• is not concurrently enrolled in a clinical trial which may impact subject health or the surgical incision site
• The Subject:
• has undergone a Class I or II CDC Wound Classification procedure resulting in a closed surgical incision able to be covered completely by the PIMS dressing

You may not qualify if:

• The Subject:
• has a BMI \< 18.5 kg/m2 and \> 40 kg/m2
• has a systemic infection at the time of open renal transplant surgery
• has a remote-site skin infection at the time of open renal transplant surgery
• is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
• Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
• \- OR -
• Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
• has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
• The Subject:
• has obvious contamination of the surgical incision
• requires external surgical drains that will be covered by the PIMS dressing
• is determined to have a CDC Wound Classification of:
• Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
• \- OR -

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Matthew Cooper
• Organization: Medstar Georgetown University Hospital

Matthew.Cooper@gunet.georgetown.edu

202-444-0753

Study Officials

• Matthew Cooper, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 25, 2011
• Study Start: August 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 16, 2024
• Results First Posted: July 2, 2017

Record last verified: 2024-10

Locations

US (1)