Back to resultsIncisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Primary Purpose
Complications Wounds, Negative Pressure Wound Therapy, Wound Healing Delayed
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incisional Negative Pressure Wound Therapy
Standard Closure with Skin Glue
PICO (Smith&Nephew)
Dermabond
Sponsored by
About this trial
This is an interventional prevention trial for Complications Wounds
Eligibility 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.
Sites / Locations
- University of California, Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Standard Closure
Incisional Negative Pressure Wound Therapy
Arm Description
After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
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.
Outcomes
Primary Outcome Measures
Major Wound Healing Complications
Abscess, Hematoma or any wound complication requiring return to the operating room.
Minor Wound Healing Complications
Cellulitis, Seroma, Superficial Wound Separation
Secondary Outcome Measures
Time to Drain Removal
Time to final drain removal after the operation
Full Information
NCT ID
NCT03010137
First Posted
January 3, 2017
Last Updated
May 29, 2020
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT03010137
Brief Title
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Official Title
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of staff resources to properly consent and enroll patients into the study.
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
March 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Closure
Arm Type
Placebo Comparator
Arm Description
After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Arm Title
Incisional Negative Pressure Wound Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Incisional Negative Pressure Wound Therapy
Intervention Type
Procedure
Intervention Name(s)
Standard Closure with Skin Glue
Intervention Type
Device
Intervention Name(s)
PICO (Smith&Nephew)
Intervention Description
Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.
Intervention Type
Device
Intervention Name(s)
Dermabond
Intervention Description
Final wound closure with skin glue.
Primary Outcome Measure Information:
Title
Major Wound Healing Complications
Description
Abscess, Hematoma or any wound complication requiring return to the operating room.
Time Frame
Up to 3 months after operation
Title
Minor Wound Healing Complications
Description
Cellulitis, Seroma, Superficial Wound Separation
Time Frame
Up to 3 months after operation
Secondary Outcome Measure Information:
Title
Time to Drain Removal
Description
Time to final drain removal after the operation
Time Frame
Up to 3 months after operation
Other Pre-specified Outcome Measures:
Title
Scarring
Description
Will assess using Vancouver Scar Scale
Time Frame
data not collected due to early termination
Title
Pain Score Self Reported by the Patient After Surgery
Description
Assess via a visual analog scale at specified intervals
Time Frame
data not collected due to early termination
Title
Quality of Life as Measured by SF-36 Validated Survey
Description
Assess via SF-36 validated survey at specified intervals
Time Frame
data not collected due to early termination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Wong, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
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