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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by KCI USA, Inc.
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT01341444
First received: April 19, 2011
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Surgical Site Reaction
Device: Prevena Incision Management System
Other: Standard of Care for Surgical Incisions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of the Prevena Incision Management System on Closed Recipient Site Incisions in Renal Transplant Subjects

Resource links provided by NLM:


Further study details as provided by KCI USA, Inc.:

Primary Outcome Measures:
  • Surgical Site Complications (SSCs) [ Time Frame: 62 Days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 88
Study Start Date: August 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevena Incision Management System
Negative Pressure Therapy Device
Device: Prevena Incision Management System
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).
Placebo Comparator: Standard of Care for Surgical Incisions
Sterile gauze and a non-penetrable barrier
Other: Standard of Care for Surgical Incisions
Sterile 4X4 Non-Penetrable barrier

Detailed Description:

This is a randomized, single-center, comparative interventional study looking at the effect of Prevena™ on renal transplant surgical Subjects compared to a control arm treated with the standard-of-care wound dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PrevenaTM in this clinical indication.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Pre-operative Inclusion Criteria

The Subject:

  1. is an adult ≥ 18 years old of either gender
  2. 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
  3. will undergo open renal transplant surgery within the next 30 days
  4. will require a surgical incision able to be covered completely by the PIMS dressing
  5. is pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:

    1. 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 -

    2. 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
  6. is willing and able to return for all scheduled and required study visits
  7. if female, must test negative on serum pregnancy test
  8. 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
  9. is not concurrently enrolled in a clinical trial which may impact subject health or the surgical incision site

Intra-operative Inclusion Criteria Subjects must meet the following intra-operative inclusion criteria to be eligible for randomization.

The Subject:

  1. continues to meet all pre-operative inclusion criteria
  2. 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

Pre-operative Exclusion Criteria

The Subject:

  1. has a BMI < 18.5 kg/m2 and > 40 kg/m2
  2. has a systemic infection at the time of open renal transplant surgery
  3. has a remote-site skin infection at the time of open renal transplant surgery
  4. is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:

    1. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract

      - OR -

    2. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
  5. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives

Intra-Operative Exclusion Criteria Subjects who meet any of the following intra-operative exclusion criteria are considered screen failures and are not eligible for randomization.

The Subject:

  1. is found to meet any of the pre-operative exclusion criteria
  2. has obvious contamination of the surgical incision
  3. requires external surgical drains that will be covered by the PIMS dressing
  4. is determined to have a CDC Wound Classification of:

    1. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract

      - OR -

    2. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera Protocol: AHS.2012.Prevena.Cooper.01 v 4.0 Confidential/Property of KCI USA, Inc. Page 8 of 71
  5. requires a transfusion, has disseminated-intravascular coagulopathy (DIC) or other medical or surgical conditions during open renal transplant surgery deemed by the Investigator to pose a prohibitively high risk for surgical re-exploration
  6. is deemed unable to continue in the study by the Investigator as the Subject's safety or well-being may be jeopardized.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341444

Contacts
Contact: Staci Poettgen 210-515-4078 staci.poettgen@kci1.com
Contact: Jill Twardowski, BSN 210-515-4166 jill.twardowski@kci1.com

Locations
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Matthew Cooper, MD    202-444-0753    Matthew.Cooper@medstar.net   
Contact: Kristen Lewis    (202) 444-2047    Kristen.A.Lewis@gunet.georgetown.edu   
Sponsors and Collaborators
KCI USA, Inc.
Investigators
Principal Investigator: Matthew Cooper, MD MedStar Georgetown University Hospital
  More Information

No publications provided

Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01341444     History of Changes
Other Study ID Numbers: AHS.2012.Prevena.Cooper.01
Study First Received: April 19, 2011
Last Updated: September 10, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 23, 2014