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

Study Overview
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Brief Summary
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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.

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

Conditions
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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 / Treatment
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* Procedure: Incisional Negative Pressure Wound Therapy
* Procedure: Standard Closure with Skin Glue
* Device: PICO (Smith&Nephew)
* Device: Dermabond


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Closure<br>After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive). | Procedure: Standard Closure with Skin Glue<br> <br> Device: Dermabond<br>* Final wound closure with skin glue.<br>|
| Active Comparator: Incisional Negative Pressure Wound Therapy<br>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<br> <br> Device: PICO (Smith&Nephew)<br>* Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.<br>|

What is the study measuring?
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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 |