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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-03-13

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.

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Detailed Description

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Closure

After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).

Group Type PLACEBO_COMPARATOR

Standard Closure with Skin Glue

Intervention Type PROCEDURE

Dermabond

Intervention Type DEVICE

Final wound closure with skin glue.

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.

Group Type ACTIVE_COMPARATOR

Incisional Negative Pressure Wound Therapy

Intervention Type PROCEDURE

PICO (Smith&Nephew)

Intervention Type DEVICE

Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.

Interventions

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Incisional Negative Pressure Wound Therapy

Intervention Type PROCEDURE

Standard Closure with Skin Glue

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Dermabond

Final wound closure with skin glue.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes