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

Not Applicable

Terminated

• Conditions: Wound Vac; Incisional; Renal Failure; Negative Pressure Wound Therapy; Incisional Negative Pressure Wound Therapy; Obese; Wound Healing Complication; Complications Wounds; Wound Healing Delayed; Incisional Vac
• Interventions: Procedure: Incisional Negative Pressure Wound Therapy; Procedure: Standard Closure with Skin Glue; Device: Dermabond; Device: PICO (Smith&Nephew)

• Registration Number: NCT03010137
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Primary Completion: 2019-03-13
• Study Completion: 2019-03-13
• Results First Submitted: 2020-03-26
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Results First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Closure	Dermabond	After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Incisional Negative Pressure Wound Therapy	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.
Standard Closure	Standard Closure with Skin Glue	After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Incisional Negative Pressure Wound Therapy	PICO (Smith&Nephew)	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.

Primary Outcome Measures

Name	Time	Method
Minor Wound Healing Complications	Up to 3 months after operation	Cellulitis, Seroma, Superficial Wound Separation
Major Wound Healing Complications	Up to 3 months after operation	Abscess, Hematoma or any wound complication requiring return to the operating room.

Secondary Outcome Measures

Name	Time	Method
Time to Drain Removal	Up to 3 months after operation	Time to final drain removal after the operation

Trial Locations

Locations (1)

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States