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Trial record 1 of 1 for:    The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing (KCI)
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The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02302222
Recruitment Status : Terminated
First Posted : November 26, 2014
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
KCI USA, Inc.

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.

Condition or disease Intervention/treatment Phase
Herniorrhaphy Abdominoplasty Device: Customizable Dressing with ActiV.A.C. Therapy Unit Device: Standard of Care Dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Management of Closed Surgical Incisions Resulting From Incisional Hernia Repair and/or Functional Panniculectomy Using the Prevena™ Customizable™ Dressing
Actual Study Start Date : May 2015
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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



Primary Outcome Measures :
  1. Number of Participants With Surgical Site Complications [ Time Frame: Within 30 Days Post-Surgical Procedure ]

    Surgical Site Complications:

    • Dehiscence
    • Surgical site infection (SSI)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302222


Locations
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United States, Florida
Medical Research Center
Miami, Florida, United States, 33144
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
KCI USA, Inc.
  Study Documents (Full-Text)

Documents provided by KCI USA, Inc.:
Study Protocol  [PDF] December 20, 2016
Statistical Analysis Plan  [PDF] September 15, 2017

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Responsible Party: KCI USA, Inc.
ClinicalTrials.gov Identifier: NCT02302222    
Other Study ID Numbers: AHS.2012.Customizable.01
First Posted: November 26, 2014    Key Record Dates
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Incisional Hernia
Surgical Wound
Hernia
Pathological Conditions, Anatomical
Wounds and Injuries
Postoperative Complications
Pathologic Processes