Continuous Treatment With PREVENA Therapy for 14 Days

Last updated: October 14, 2024
Sponsor: KCI USA, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedic Surgery

Cardiac Surgery

Orthopedics

Treatment

Prevena Plus Incision Management System with Prevena Dressings

Clinical Study ID

NCT05614869
EM-05-014992
  • Ages > 22
  • All Genders

Study Summary

The purpose of this study is to demonstrate substantial equivalence in terms of safety to support an indication change related to the usage of Prevena Therapy for up to 14 days. The enrolled subject will undergo 1 of 4 surgery types and be evaluated for up to 90 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is at least 22 years of age on the date of informed consent

  • Subject can provide informed consent

  • Subject requires a surgical procedure for 1 of the 4 specialty treatment groups (ie,lower extremity orthopedic procedure, abdominal or C-section procedure, sternotomy,or vascular procedure)

  • Subject is willing and able to return for all scheduled study visits.

  • Subject has 1 or more of the following risk factors for post-surgical complications:

  • BMI ≥ 30

  • diabetes

  • history of smoking

  • immune suppression or receiving drugs that can cause immune suppression (eg,steroids, chemotherapeutic medications, and/or antimetabolites)

  • high risk for malnutrition, as indicated by 2 or more of the following1:

  • insufficient energy intake

  • loss of muscle mass

  • loss of subcutaneous fat

  • localized or generalized fluid accumulation that may mask weight loss

  • diminished functional status as measured by hand-grip strength

  • OR -

  • has malnutrition, as determined by the investigator

  • neutropenia

  • cardiac, pulmonary, liver, or renal disease

  • history of previous surgery or radiation in the treatment area

  • Subject is pre-operatively assessed to undergo a procedure with a CDC WoundClassification of:

  • Class I (Clean): An uninfected operative wound in which no inflammation isencountered, and the respiratory, alimentary, genital, or uninfected urinarytract is not entered

  • OR -

  • Class II (Clean Contaminated): An operative wound in which the respiratory,alimentary, genital, or uninfected urinary tract are entered under controlledconditions and without unusual contamination

  • Subject has a closed post-surgical incision for which the anticipated duration ofPrevena Therapy is more than 11 days

Exclusion

Exclusion Criteria:

  • Subject is female and, except in the case of C-section procedures, is pregnant orlactating prior to surgery

  • Subject has signs of an infection in the surgical area or has signs of a systemicinfection at the time of surgery

  • Subject is a chronic opioid user, defined per the CDC guidelines as opioid use for > 3 months, at the time of enrollment

  • Subject has any of the following:

  • condition(s) that, in the opinion of the investigator, cause the patient to bean overall health risk that is unsuitable for the surgery

  • known sensitivity to the study product components (drape and/or dressingmaterials in direct contact with the closed incision or skin)

  • known sensitivity to silver

  • skin cancer localized at or in proximity to the incision site

  • intraoperative issue(s) that precludes the use of Prevena Therapy

  • Subject is preoperatively assessed to undergo a procedure with a CDC WoundClassification of:

  • Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaksin sterile technique or gross spillage from the gastrointestinal tract

  • OR -

  • Class IV (Dirty-Infected): Old traumatic wounds with retained devitalizedtissue and those that involve existing clinical infection or perforated viscera

  • Subject is enrolled in another interventional clinical study

Study Design

Total Participants: 353
Treatment Group(s): 1
Primary Treatment: Prevena Plus Incision Management System with Prevena Dressings
Phase:
Study Start date:
February 02, 2023
Estimated Completion Date:
May 25, 2027

Connect with a study center

  • Insight Hospital and Medical Center

    Chicago, Illinois 60616
    United States

    Site Not Available

  • IU Health

    Fishers, Indiana 46037
    United States

    Site Not Available

  • Sinai Hospital of Baltimore

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Bryan Heart

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • WakeMed Heart & Vascular

    Raleigh, North Carolina 27610
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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