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

University of California (UC) Davis

Status: Terminated

Conditions: Obese; Complications Wounds; Wound Vac; Kidney Transplant; Complications; Incisional; Negative Pressure Wound Therapy; Renal Failure; Incisional Negative Pressure Wound Therapy; Panniculectomy; Wound Healing Complication; Wound Healing Delayed; Incisional Vac

Treatments: Device: Dermabond; Procedure: Incisional Negative Pressure Wound Therapy; Procedure: Standard Closure with Skin Glue; Device: PICO (Smith&Nephew)

Study type: Interventional

Funder types: Other

Identifiers

NCT03010137

801708

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Standard Closure

Placebo Comparator group

Description:

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

Treatment:

Device: Dermabond

Procedure: Standard Closure with Skin Glue

Incisional Negative Pressure Wound Therapy

Active Comparator group

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.

Treatment:

Procedure: Incisional Negative Pressure Wound Therapy

Device: PICO (Smith&Nephew)