[Trial of device that is not approved or cleared by the U.S. FDA]

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.

Study Overview

• Status: Withheld
• Conditions: Abdominal Surgery; Orthopedic Surgery; Vascular Surgery; Cardiovascular Surgery
• Intervention / Treatment: Device: Prevena Plus Incision Management System with Prevena Dressings

• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fishers, Indiana, United States, 46037
      • Not yet recruiting
      • IU Health
      • Contact: Bobby Lyssikatos, MD; Email: clyssika@iu.edu
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Yasin Mohamed, BA; Email: ymohamed@lifebridgehealth.org
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
      • Bryan Heart
      • Contact: Nicci Thompson, RN/BSN, CCRC; Email: nicci.thompson@bryanheart.com
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • WakeMed Heart & Vascular
      • Contact: Haleigh Berst, BSCR; Email: hberst@wakemed.org
      • Contact: Taylor Guidi, BSCR; Email: tguidi@wakemed.org
  • Oregon
    • Portland, Oregon, United States, 97239
      • Active, not recruiting
      • Oregon Health & Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Hannah Culpepper; Email: culpepph@musc.edu
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Medical College of Wisconsin
      • Contact: Caroline Herdeman; Email: cherdeman@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• Subject is female and, except in the case of C-section procedures, is pregnant or lactating prior to surgery
• Subject has signs of an infection in the surgical area or has signs of a systemic infection 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 be an overall health risk that is unsuitable for the surgery
  • known sensitivity to the study product components (drape and/or dressing materials 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 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
• Subject is enrolled in another interventional clinical study

Study Plan

How is the study designed?

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Subjects undergoing 1 of 4 types of surgery will be enrolled and treated with the PREVENA Plus Incision Management System	Device: Prevena Plus Incision Management System with Prevena Dressings; Negative pressure pump and dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	The incidence of rate of surgical site complications (SSCs), defined as any surgical site infection (SSI), seroma, hematoma, dehiscence, or skin necrosis occurring within 30 days (± 4 days) of the surgical procedure, as measured by the proportion of subjects who experienced at least one SSC within 30 days of the surgical procedure.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Complications_30	The number and type of SSCs within 30 days of the surgical procedure, including SSI, seroma, hematoma, dehiscence, and skin necrosis	30 Days
Surgical Site Complications_90	The number and type of SSCs within 90 days of the surgical procedure, including SSI, seroma, hematoma, dehiscence, and skin necrosis	90 Days
Surgical Site Infections	The incidence rate of SSI (superficial or deep) within 30 days of the surgical procedure	30 Days
Seroma	The incidence rate of seroma within 30 days of the surgical procedure	30 Days
Hematoma	The incidence rate of hematoma within 30 days of the surgical procedure	30 Days
Dehiscence	The incidence rate of dehiscence within 30 days of the surgical procedure	30 Days
Skin Necrosis	The incidence rate of skin necrosis within 30 days of the surgical procedure	30 Days

Collaborators and Investigators

• Sponsor: [Redacted]
• Collaborators: 3M; Solventum US LLC

Publications and helpful links

Helpful Links

• Study Product Information

Study record dates

Study Major Dates

• Study Start: February 2, 2023
• Primary Completion: March 15, 2027
• Study Completion: May 25, 2027

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Total Knee Replacement; Abdominal Surgery; Total Hip Replacement; Median Sternotomy; Groin Surgery
• Other Study ID Numbers: EM-05-014992

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes