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

NCT03010137 — Not applicable, Terminated, 30 participants, University of California, Davis

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RegistryNCT03010137
StatusTerminated - Lack of staff resources to properly consent and enroll patients into the study.
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment30 (Actual)
SponsorUniversity of California, Davis (Other)
ConditionsComplications 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
InterventionsIncisional Negative Pressure Wound Therapy, Standard Closure with Skin Glue, PICO (Smith&Nephew), Dermabond (Procedure, device)
Datesstart 2015-12-01, primary completion 2019-03-13, completion 2019-03-13, first posted 2017-01-04, last updated 2020-06-09
Locations1 site in United States

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Standard ClosurePlacebo comparatorProcedure: Standard Closure with Skin Glue; Device: DermabondAfter surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Incisional Negative Pressure Wound TherapyActive comparatorProcedure: Incisional Negative Pressure Wound Therapy; Device: 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.
  • Incisional Negative Pressure Wound Therapy (Procedure)
  • Standard Closure with Skin Glue (Procedure)
  • 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.
  • Dermabond (Device): Final wound closure with skin glue.

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Time to Drain Removal [Up to 3 months after operation]: Time to final drain removal after the operation

Other outcomes

  • Scarring [data not collected due to early termination]: Will assess using Vancouver Scar Scale
  • Pain Score Self Reported by the Patient After Surgery [data not collected due to early termination]: Assess via a visual analog scale at specified intervals
  • Quality of Life as Measured by SF-36 Validated Survey [data not collected due to early termination]: Assess via SF-36 validated survey at specified intervals

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Posted results

Participant flow

MilestoneStandard ClosureIncisional Negative Pressure Wound Therapy
Started1515
Completed1515
Not completed00

Outcome results

  • Major Wound Healing Complications (Primary), Count of participants, Participants: Standard Closure 5; Incisional Negative Pressure Wound Therapy 3
  • Minor Wound Healing Complications (Primary), Count of participants, Participants: Standard Closure 3; Incisional Negative Pressure Wound Therapy 2
  • Time to Drain Removal (Secondary), Mean, days: Standard Closure 29 +/- 14.1; Incisional Negative Pressure Wound Therapy 24 +/- 13.5
  • Scarring (Other pre specified)
  • Pain Score Self Reported by the Patient After Surgery (Other pre specified)
  • Quality of Life as Measured by SF-36 Validated Survey (Other pre specified)

Adverse events

Time frame: 6 months period following panniculectomy surgery

ArmDeathsSerious adverse eventsOther adverse events
Standard Closure0/15 (0.0%)0/15 (0.0%)0/15 (0.0%)
Incisional Negative Pressure Wound Therapy0/15 (0.0%)0/15 (0.0%)0/15 (0.0%)

+Locations (1)

FacilityCityCountryStatus
University of California, Davis Medical CenterSacramento, CaliforniaUnited States

+Study documents

+Investigators

My Notes