The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functi… (NCT02302222) | Clinical Trial Compass
TerminatedNot Applicable
The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing
United States71 participantsStarted 2015-05
Plain-language summary
The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to SOC dressing, and to significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. an adult 18 years old or older of either gender
. able to provide their own informed consent
. will undergo:
. a functional panniculectomy with a transverse or a fleur-de-lis incision
. an incisional hernia repair with a vertical incision at least 20 cm in length and at least 10 cm of undermining on each side of the incision
. BMI equal to or greater than 30
. has maintained a stable weight for at least 3 months as determined by the Investigator (applies to post weight loss patients only)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Surgical Site Complications
. pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
Exclusion criteria
. has a systemic bacterial or fungal infection at the time of surgery for incisional hernia repair and/or functional panniculectomy
. has a remote-site skin infection at the time of surgery for incisional hernia repair or functional panniculectomy
. pre-operatively 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
. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
. will have a transverse or fleur-de-lis incision that extends beyond the flank area and requires moving the Subject from the supine position during surgery
. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
. has participated in a clinical study within the past 30 days