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

• ClinicalTrials.gov Identifier: NCT01341444
• Recruitment Status: Terminated
• First Posted: April 25, 2011
• Results First Posted: July 2, 2017
• Last Update Posted: July 2, 2017
• Sponsor: KCI USA, Inc.
• Information provided by (Responsible Party): KCI USA, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgical Site Reaction	Device: Prevena Incision Management System; Other: Standard of Care for Surgical Incisions	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of the Prevena Incision Management System on Closed Recipient Site Incisions in Renal Transplant Subjects
• Study Start Date: August 2013
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Surgical Site Complications (SSCs) [ Time Frame: 62 Days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, District of Columbia

MedStar Georgetown University Hospital

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

Sponsors and Collaborators

KCI USA, Inc.

Investigators

• Principal Investigator: Matthew Cooper, MD; MedStar Georgetown University Hospital

More Information

• Responsible Party: KCI USA, Inc.
• ClinicalTrials.gov Identifier: NCT01341444
• Other Study ID Numbers: AHS.2012.Prevena.Cooper.01
• First Posted: April 25, 2011
• Results First Posted: July 2, 2017
• Last Update Posted: July 2, 2017
• Last Verified: June 2017

Additional relevant MeSH terms:

Surgical Wound; Wounds and Injuries