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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of the Prevena Incision Management System on Closed Recipient Site Incisions in Renal Transplant Subjects

Conditions
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Surgical Site Reaction

Intervention / Treatment
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* Device: Prevena Incision Management System
* Other: Standard of Care for Surgical Incisions


Participation Criteria
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Eligibility Criteria
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Pre-operative Inclusion Criteria 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 Intra-operative Inclusion Criteria Subjects must meet the following intra-operative inclusion criteria to be eligible for randomization. The Subject: continues to meet all pre-operative inclusion criteria 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: 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 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: is found to meet any of the pre-operative exclusion criteria 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 - 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 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 is deemed unable to continue in the study by the Investigator as the Subject's safety or well-being may be jeopardized.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena Incision Management System<br>Negative Pressure Therapy Device | Device: Prevena Incision Management System<br>* 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).<br>|
| Placebo Comparator: Standard of Care for Surgical Incisions<br>Sterile gauze and a non-penetrable barrier | Other: Standard of Care for Surgical Incisions<br>* Sterile 4X4 Non-Penetrable barrier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |