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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03010137
• Other study ID #: 801708
• Status: Terminated
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 13, 2019

Study information

• Verified date: May 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 13, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complications Wounds
• Incisional
• Incisional Negative Pressure Wound Therapy
• Incisional Vac
• Kidney Transplant; Complications
• Negative Pressure Wound Therapy
• Obese
• Panniculectomy
• Renal Failure
• Wound Healing Complication
• Wound Healing Delayed
• Wound Vac
• Wounds and Injuries

Intervention

Procedure:
• Incisional Negative Pressure Wound Therapy

• Standard Closure with Skin Glue

Device:
• 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.
• Dermabond
Final wound closure with skin glue.

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scarring	Will assess using Vancouver Scar Scale	data not collected due to early termination
Other	Pain Score Self Reported by the Patient After Surgery	Assess via a visual analog scale at specified intervals	data not collected due to early termination
Other	Quality of Life as Measured by SF-36 Validated Survey	Assess via SF-36 validated survey at specified intervals	data not collected due to early termination
Primary	Major Wound Healing Complications	Abscess, Hematoma or any wound complication requiring return to the operating room.	Up to 3 months after operation
Primary	Minor Wound Healing Complications	Cellulitis, Seroma, Superficial Wound Separation	Up to 3 months after operation
Secondary	Time to Drain Removal	Time to final drain removal after the operation	Up to 3 months after operation