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

NCT03010137 | Terminated Results

• 1 other identifier: 801708
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Major Wound Healing Complications

  Abscess, Hematoma or any wound complication requiring return to the operating room.

  Up to 3 months after operation

• Minor Wound Healing Complications

  Cellulitis, Seroma, Superficial Wound Separation

  Up to 3 months after operation

Secondary Outcomes (1)

• Time to Drain Removal

  Up to 3 months after operation

Other Outcomes (3)

• Scarring

  data not collected due to early termination

• Pain Score Self Reported by the Patient After Surgery

  data not collected due to early termination

• Quality of Life as Measured by SF-36 Validated Survey

  data not collected due to early termination

Study Arms (2)

Standard Closure

PLACEBO COMPARATOR

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

Procedure: Standard Closure with Skin Glue; Device: Dermabond

Incisional Negative Pressure Wound Therapy

ACTIVE COMPARATOR

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.

Procedure: Incisional Negative Pressure Wound Therapy; Device: PICO (Smith&Nephew)

Interventions

Incisional Negative Pressure Wound Therapy PROCEDURE

Incisional Negative Pressure Wound Therapy

Standard Closure with Skin Glue PROCEDURE

Standard Closure

PICO (Smith&Nephew) DEVICE

Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.

Incisional Negative Pressure Wound Therapy

Dermabond DEVICE

Final wound closure with skin glue.

Standard Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Surgical Wound; Obesity; Renal Insufficiency

Condition Hierarchy (Ancestors)

Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Yunfeng Xue
• Organization: UC Davis Medical Center

yunxue@ucdavis.edu

408-603-0507

Study Officials

• Michael S Wong, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 4, 2017
• Study Start: December 1, 2015
• Primary Completion: March 13, 2019
• Study Completion: March 13, 2019
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Locations

US (1)