Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 4, 2017
Results First Submitted Date  ICMJE March 26, 2020
Results First Posted Date  ICMJE June 9, 2020
Last Update Posted Date June 9, 2020
Study Start Date  ICMJE December 2015
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Major Wound Healing Complications [ Time Frame: Up to 3 months after operation ]
    Abscess, Hematoma or any wound complication requiring return to the operating room.
  • Minor Wound Healing Complications [ Time Frame: Up to 3 months after operation ]
    Cellulitis, Seroma, Superficial Wound Separation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
Time to Drain Removal [ Time Frame: Up to 3 months after operation ]
Time to final drain removal after the operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 29, 2020)
  • Scarring [ Time Frame: data not collected due to early termination ]
    Will assess using Vancouver Scar Scale
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: January 3, 2017)
  • Scarring [ Time Frame: Up to 6 months after operation ]
    Will assess using Vancouver Scar Scale
  • Pain [ Time Frame: Up to 6 months after operation ]
    Assess via a visual analog scale at specified intervals
  • Quality of Life [ Time Frame: Up to 6 months after operation ]
    Assess via SF-36 validated survey at specified intervals
 
Descriptive Information
Brief Title  ICMJE Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Official Title  ICMJE Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: Incisional Negative Pressure Wound Therapy
  • Procedure: Standard Closure with Skin Glue
  • 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.
  • Device: Dermabond
    Final wound closure with skin glue.
Study Arms  ICMJE
  • Placebo Comparator: Standard Closure
    After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
    Interventions:
    • Procedure: Standard Closure with Skin Glue
    • Device: Dermabond
  • 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.
    Interventions:
    • Procedure: Incisional Negative Pressure Wound Therapy
    • Device: PICO (Smith&Nephew)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 26, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2017)
20
Actual Study Completion Date  ICMJE March 13, 2019
Actual Primary Completion Date March 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03010137
Other Study ID Numbers  ICMJE 801708
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael S Wong, MD University of California, Davis
PRS Account University of California, Davis
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP