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

This study is not yet open for participant recruitment.
Verified July 2011 by KCI USA, Inc.
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT01341444
First received: April 19, 2011
Last updated: February 6, 2012
Last verified: July 2011
History of Changes
  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 7 days after your 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 4

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 Transplantation Subjects

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Surgical Site Occurrences (SSOs) [ Time Frame: 42 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 Occurrences (SSOs) that include unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, & surgical site infection. 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: 50
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevena Incision Management System 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 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

Inclusion Criteria:

  • The Subject is an adult at least 18 years old of either gender who is able to provide their own informed consent.
  • The Subject will undergo an open renal transplant procedure
  • The Subject will require a surgical incision able to be covered by the Prevena Skin interface.

  • The Subject has 2 or more of the following concomitant disorders/conditions.

    • will receive chronic immunosuppressant therapy during the study period (equivalent of ≥ 10 mg Prednisone QD)
    • BMI ≥ 30 kg/m2
    • diabetic (only Type I or Type II insulin-dependent or receiving chronic oral hypoglycemic medication)

  • The Subject is preoperatively 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
  • The Subject is willing and able to return for all scheduled and required study visits
  • The Subject who is female and of childbearing potential must test negative on urine pregnancy test and be willing to utilize an acceptable method of birth control (eg, birth control pills, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch, etc) for the duration of study participation

Exclusion Criteria:

  • The Subject has a systemic infection at the time of surgery
  • The Subject has a remote-site skin infection at the time of surgery
  • The Subject has a life expectancy of < 12 months

  • The Subject 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
  • The Subject who, in the investigator's opinion, would have any clinically significant condition that would impair the participant's ability to comply with the study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341444

Locations
United States, Maryland
University of Maryland Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Matthew Cooper, MD     410-328-7336     mcooper@smail.umaryland.edu    
Contact: Ilze Sikorski, RN     410-328-0303     isikorski@smail.umaryland.edu    
Sponsors and Collaborators
KCI USA, Inc.
Investigators
Principal Investigator: Matthew Cooper, MD University of Maryland
  More Information

No publications provided

Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT01341444     History of Changes
Other Study ID Numbers: AHS.2011.Prevena.Cooper.01
Study First Received: April 19, 2011
Last Updated: February 6, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013