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

Stopped early · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03010137

Run by

University of California, Davis

People needed

30

Starts

2015-12-01

Expected to finish

2019-03-13

Last updated by the study team

2020-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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