Clinical trial NCT02302222: The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing
Official title: The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Herniorrhaphy
Abdominoplasty
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2014-11-26
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Pre-Operative Inclusion Criteria:

1. an adult 18 years old or older of either gender
2. able to provide their own informed consent
3. 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
4. BMI equal to or greater than 30
5. has maintained a stable weight for at least 3 months as determined by the Investigator (applies to post weight loss patients only)
6. 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
7. willing and able to return for all scheduled study visits
8. if a female of child-bearing potential, must test negative on a urine pregnancy test
9. 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:

1. continues to meet all pre-operative inclusion criteria
2. 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:

1. has a systemic bacterial or fungal infection at the time of surgery for incisional hernia repair and/or functional panniculectomy
2. has a remote-site skin infection at the time of surgery for incisional hernia repair or functional panniculectomy
3. 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
4. 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
5. has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
6. has participated in a clinical study within the past 30 days
7. 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:

1. found to meet any of the pre-operative exclusion criteria
2. 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

Primary outcomes:
measure: Number of Participants With Surgical Site Complications
timeFrame: Within 30 Days Post-Surgical Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Medical Research Center
state: Florida
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
References: