The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing

Not Applicable

Terminated

Interventions: Device: Customizable Dressing with ActiV.A.C. Therapy Unit
Device: Standard of Care Dressing

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

an adult 18 years old or older of either gender
able to provide their own informed consent
will undergo:
1. a functional panniculectomy with a transverse or a fleur-de-lis incision
  - AND/OR -
2. 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:
1. 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 -
2. 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
willing and able to return for all scheduled study visits
if a female of child-bearing potential, must test negative on a urine pregnancy test
if a female of child-bearing potential, must be willing to utilize an acceptable method of birth control (i.e. oral contraceptives, condom with spermicide, diaphragm with spermicide, implants, IUD, injections, vaginal rings, hormonal skin patch) for the duration of the study

Intra-Operative Inclusion Criteria:

continues to meet all pre-operative inclusion criteria
has undergone a Class I or II CDC Wound Classification procedure resulting in a closed surgical incision able to be covered completely by Customizable dressing

Pre-Operative

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:
1. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
  - OR -
2. 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
who, in the investigator's opinion, would have any clinically significant condition that would impair the Subject's ability to comply with the study procedures

Post-Operative Exclusion Criteria:

found to meet any of the pre-operative exclusion criteria
determined to have a CDC Wound Classification of:
1. Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
  - OR -
2. Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera

Arm && Interventions

Group	Intervention	Description
Customizable	Customizable Dressing with ActiV.A.C. Therapy Unit	Prevena Customizable Dressing with ActiV.A.C. Therapy Unit
Standard of Care	Standard of Care Dressing	dry sterile dressing/gauze and steristrips

Primary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Site Complications	Within 30 Days Post-Surgical Procedure	Surgical Site Complications: * Dehiscence * Surgical site infection (SSI)

Secondary Outcome Measures

Name	Time	Method

Locations (2): Medical Research Center
🇺🇸
Miami, Florida, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States