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

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.

Study Overview

• Status: Terminated
• Conditions: Abdominoplasty; Herniorrhaphy
• Intervention / Treatment: Device: Standard of Care Dressing; Device: Customizable Dressing with ActiV.A.C. Therapy Unit

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33144
      • Medical Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; dry sterile dressing/gauze and steristrips	Device: Standard of Care Dressing
Experimental: Customizable; Prevena Customizable Dressing with ActiV.A.C. Therapy Unit	Device: Customizable Dressing with ActiV.A.C. Therapy Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Surgical Site Complications	Surgical Site Complications: Dehiscence; Surgical site infection (SSI)	Within 30 Days Post-Surgical Procedure

Collaborators and Investigators

• Sponsor: KCI USA, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 24, 2014
• First Posted (Estimated): November 26, 2014

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Pathological Conditions, Anatomical; Hernia; Surgical Wound; Incisional Hernia
• Other Study ID Numbers: AHS.2012.Customizable.01