Continuous Treatment With PREVENA Therapy for 14 Days

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614869
• Other study ID #: EM-05-014992
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: May 25, 2027

Study information

• Verified date: March 2024
• Source: 3M
• Contact: Eric Synatschk, MS, CCRP
• Phone: 346-550-5698
• Email: esynatschk[@]solventum.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 353
• Est. completion date: May 25, 2027
• Est. primary completion date: March 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Cardiovascular Surgery
• Orthopedic Surgery
• Vascular Surgery

Intervention

Device:
• Prevena Plus Incision Management System with Prevena Dressings
Negative pressure pump and dressings

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Insight Hospital and Medical Center	Chicago	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Oregon Health & Science University	Portland	Oregon
United States	WakeMed Heart & Vascular	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical Site Complications_30	The number and type of SSCs within 30 days (± 4 days) of the surgical procedure, including SSI, seroma, hematoma, dehiscence, and skin necrosis	30 Days
Secondary	Surgical Site Complications_90	The number and type of SSCs within 90 days (± 7 days) of the surgical procedure, including SSI, seroma, hematoma, dehiscence, and skin necrosis	90 Days
Secondary	Surgical Site Infections	The incidence rate of SSI (superficial or deep) within 30 days (± 4 days) of the surgical procedure	30 Days
Secondary	Seroma	The incidence rate of seroma within 30 days (± 4 days) of the surgical procedure	30 Days
Secondary	Hematoma	The incidence rate of hematoma within 30 days (± 4 days) of the surgical procedure	30 Days
Secondary	Dehiscence	The incidence rate of dehiscence within 30 days (± 4 days) of the surgical procedure	30 Days
Secondary	Skin Necrosis	The incidence rate of skin necrosis within 30 days (± 4 days) of the surgical procedure	30 Days