The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant … (NCT01341444) | Clinical Trial Compass
TerminatedNot Applicable
The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects
Stopped: Enrollment Difficulties
United States63 participantsStarted 2013-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
What they're measuring
1
Number of Participants With Surgical Site Complications (SSCs)
✕. 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
✕. 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
✕. is found to meet any of the pre-operative exclusion criteria