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

NCT02302222 | Terminated Results

• 1 other identifier: AHS.2012.Customizable.01
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

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.

Conditions

Herniorrhaphy; Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Surgical Site Complications

  Surgical Site Complications: * Dehiscence * Surgical site infection (SSI)

  Within 30 Days Post-Surgical Procedure

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

dry sterile dressing/gauze and steristrips

Device: Standard of Care Dressing

Customizable

EXPERIMENTAL

Prevena Customizable Dressing with ActiV.A.C. Therapy Unit

Device: Customizable Dressing with ActiV.A.C. Therapy Unit

Interventions

Customizable Dressing with ActiV.A.C. Therapy Unit DEVICE

Customizable

Standard of Care Dressing DEVICE

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• AND/OR -
• 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:
• 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 -
• 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

You may not qualify if:

• 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
• OR -
• 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
• determined to have 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
• OR -
• Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera

Sponsors & Collaborators

• KCI USA, Inc: lead

Study Sites (2)

Medical Research Center

Miami, Florida, 33144, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Limitations and Caveats

The study was terminated after an interim data review as the SSC rates were outside the ranges of the sample size assumptions used for the study design.

Results Point of Contact

• Title: Sr Director, Global Clinical Development
• Organization: Acelity

jane.hart@acelity.com

2102555595

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: May 1, 2015
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: October 16, 2024
• Results First Posted: December 12, 2018

Record last verified: 2024-10

Locations

US (2)