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

Not Applicable

• Conditions: Orthopedic Surgery; Vascular Surgery; Abdominal Surgery; Cardiovascular Surgery
• Interventions: Device: Prevena Plus Incision Management System with Prevena Dressings

• Registration Number: NCT05614869
• Lead Sponsor: [Redacted]

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-14
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: WITHHELD
• Sex: All
• Target Recruitment: 353

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Prevena Plus Incision Management System with Prevena Dressings	Subjects undergoing 1 of 4 types of surgery will be enrolled and treated with the PREVENA Plus Incision Management System

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	30 Days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

IU Health; 🇺🇸 Fishers, Indiana, United States

Bryan Heart; 🇺🇸 Lincoln, Nebraska, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

WakeMed Heart & Vascular; 🇺🇸 Raleigh, North Carolina, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States