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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05614869
Other study ID # EM-05-014992
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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