Clinical trial NCT03010137: Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Official title: Incisional Negative Pressure Wound Therapy in High Risk Patients Undergoing Panniculectomy: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major Wound Healing Complications
timeFrame: Up to 3 months after operation
measure: Minor Wound Healing Complications
timeFrame: Up to 3 months after operation
Secondary outcomes:
measure: Time to Drain Removal
timeFrame: Up to 3 months after operation
Other outcomes:
measure: Scarring
timeFrame: data not collected due to early termination
measure: Pain Score Self Reported by the Patient After Surgery
timeFrame: data not collected due to early termination
measure: Quality of Life as Measured by SF-36 Validated Survey
timeFrame: data not collected due to early termination
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Michael S Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: