RECRUITING

Continuous Treatment With PREVENA Therapy for 14 Days

Conditions

Abdominal Surgery Orthopedic Surgery Cardiovascular Surgery Vascular Surgery Median Sternotomy Total Hip Replacement Total Knee Replacement Groin Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 Days

Quick Facts

Study Start:2023-02-02

Study Completion:2027-05-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05614869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Eric Synatschk, MS, CCRP

CONTACT

346-550-5698

esynatschk@solventum.com

Study Locations (Sites)

IU Health

Fishers, Indiana, 46037

United States

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

United States

Bryan Heart

Lincoln, Nebraska, 68506

United States

WakeMed Heart & Vascular

Raleigh, North Carolina, 27610

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: KCI USA, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-02

Study Completion Date2027-05-25

Study Record Updates

Study Start Date2023-02-02

Study Completion Date2027-05-25

Terms related to this study

Keywords Provided by Researchers

Median Sternotomy
Total Hip Replacement
Total Knee Replacement
Groin Surgery
Abdominal Surgery

Additional Relevant MeSH Terms

Abdominal Surgery
Orthopedic Surgery
Cardiovascular Surgery
Vascular Surgery