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Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial

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: NCT03010137
Recruitment Status : Terminated (Lack of staff resources to properly consent and enroll patients into the study.)
First Posted : January 4, 2017
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
Incisional negative pressure therapy (INPWT) has previously been shown in certain patient populations to decrease wound healing complications, decrease the rate of hematomas and seromas, as well as have better scar quality. We have found a group of patients, those who have panniculectomies in preparation for renal transplant, with significantly higher rates of wound healing complications. We believe the best way to demonstrate benefits of incisional negative pressure wound therapy will be in this group of patients known to have significantly higher rates of wound complications.

Condition or disease Intervention/treatment Phase
Complications Wounds Negative Pressure Wound Therapy Wound Healing Delayed Incisional Panniculectomy Incisional Negative Pressure Wound Therapy Incisional Vac Wound Vac Obese Renal Failure Kidney Transplant; Complications Wound Healing Complication Procedure: Incisional Negative Pressure Wound Therapy Procedure: Standard Closure with Skin Glue Device: PICO (Smith&Nephew) Device: Dermabond Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Study Start Date : December 2015
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 13, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard Closure
After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Procedure: Standard Closure with Skin Glue
Device: Dermabond
Final wound closure with skin glue.

Active Comparator: Incisional Negative Pressure Wound Therapy
After surgical closure is complete, an incisional negative pressure wound therapy device is applied to the incision in its entirety. This device is placed on the wound, sterilely, in the operating room, at the conclusion of the procedure. The incisional negative pressure wound therapy device is to remain in place for 7 days, and is removed in clinic after completion.
Procedure: Incisional Negative Pressure Wound Therapy
Device: PICO (Smith&Nephew)
Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.




Primary Outcome Measures :
  1. Major Wound Healing Complications [ Time Frame: Up to 3 months after operation ]
    Abscess, Hematoma or any wound complication requiring return to the operating room.

  2. Minor Wound Healing Complications [ Time Frame: Up to 3 months after operation ]
    Cellulitis, Seroma, Superficial Wound Separation


Secondary Outcome Measures :
  1. Time to Drain Removal [ Time Frame: Up to 3 months after operation ]
    Time to final drain removal after the operation


Other Outcome Measures:
  1. Scarring [ Time Frame: data not collected due to early termination ]
    Will assess using Vancouver Scar Scale

  2. Pain Score Self Reported by the Patient After Surgery [ Time Frame: data not collected due to early termination ]
    Assess via a visual analog scale at specified intervals

  3. Quality of Life as Measured by SF-36 Validated Survey [ Time Frame: data not collected due to early termination ]
    Assess via SF-36 validated survey at specified intervals



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients undergoing panniculectomy in preparation for renal transplantation at the University of California Davis Medical Center. Patients who are entered into the trial and have 30 days of follow up, and those in the INPWT study arm who successfully complete 7 days of treatment, will be included.

Exclusion Criteria:

  • All patients who previously demonstrated a hypersensitivity reaction to adhesives and qualify for panniculectomy in preparation for renal transplantation, or all patients who are undergoing panniculectomy for reasons other than in preparation for renal transplantation (i.e. after massive weight loss or for cosmetic reasons). Patients who do not complete the duration of treatment of negative pressure wound therapy (7 days), or patients who do not follow up for a minimum of 30 days from the date of surgery will be excluded. Adults unable to consent, infants, children, teenagers, pregnant patients and prisoners will be excluded. It is also extremely unlikely, based on our study population, that we will encounter any of these patients.

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): NCT03010137


Locations
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United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Michael S Wong, MD University of California, Davis
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Informed Consent Form  [PDF] March 20, 2019

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03010137    
Other Study ID Numbers: 801708
First Posted: January 4, 2017    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Wounds and Injuries