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

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.

Study Overview

• Status: Terminated
• Conditions: Renal Failure; Obese; Kidney Transplant; Complications; Negative Pressure Wound Therapy; Incisional Negative Pressure Wound Therapy; Complications Wounds; Wound Healing Delayed; Incisional; Panniculectomy; Incisional Vac; Wound Vac; Wound Healing Complication
• Intervention / Treatment: Procedure: Standard Closure with Skin Glue; Device: Dermabond; Procedure: Incisional Negative Pressure Wound Therapy; Device: PICO (Smith&Nephew)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Wound Healing Complications	Abscess, Hematoma or any wound complication requiring return to the operating room.	Up to 3 months after operation
Minor Wound Healing Complications	Cellulitis, Seroma, Superficial Wound Separation	Up to 3 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Drain Removal	Time to final drain removal after the operation	Up to 3 months after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scarring	Will assess using Vancouver Scar Scale	data not collected due to early termination
Pain Score Self Reported by the Patient After Surgery	Assess via a visual analog scale at specified intervals	data not collected due to early termination
Quality of Life as Measured by SF-36 Validated Survey	Assess via SF-36 validated survey at specified intervals	data not collected due to early termination

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Michael S Wong, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 13, 2019
• Study Completion (Actual): March 13, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 801708