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 Prevenaâ„¢ Customizableâ„¢ 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 range18 Years
SexALL
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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)
✓. 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
What they're measuring
1
Number of Participants With Surgical Site Complications
. 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