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
Conditions
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.
Interventions
PROCEDUREStandard Closure with Skin Glue
DEVICEPICO (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.
DEVICEDermabond
Final wound closure with skin glue.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to Drain Removal | Up to 3 months after operation | Time to final drain removal after the operation |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Closure After surgical closure is complete, the patient receives standard of care operative incision treatment (dermabond/topical skin adhesive).
Standard Closure with Skin Glue
Dermabond: Final wound closure with skin glue. | 15 |
| 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.
Incisional Negative Pressure Wound Therapy
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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Incisional Negative Pressure Wound Therapy | Total | Standard Closure |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 28 Participants | 15 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | 55.6 years STANDARD_DEVIATION 12.7 | 54 years STANDARD_DEVIATION 8.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Major Wound Healing Complications
Abscess, Hematoma or any wound complication requiring return to the operating room.
Time frame: Up to 3 months after operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Closure | Major Wound Healing Complications | 5 Participants |
| Incisional Negative Pressure Wound Therapy | Major Wound Healing Complications | 3 Participants |
Primary
Minor Wound Healing Complications
Cellulitis, Seroma, Superficial Wound Separation
Time frame: Up to 3 months after operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Closure | Minor Wound Healing Complications | 3 Participants |
| Incisional Negative Pressure Wound Therapy | Minor Wound Healing Complications | 2 Participants |
Secondary
Time to Drain Removal
Time to final drain removal after the operation
Time frame: Up to 3 months after operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Closure | Time to Drain Removal | 29 days | Standard Deviation 14.1 |
| Incisional Negative Pressure Wound Therapy | Time to Drain Removal | 24 days | Standard Deviation 13.5 |
Other Pre-specified
Pain Score Self Reported by the Patient After Surgery
Assess via a visual analog scale at specified intervals
Time frame: data not collected due to early termination
Population: Unable to perform final analysis due to early closure of the study
Other Pre-specified
Quality of Life as Measured by SF-36 Validated Survey
Assess via SF-36 validated survey at specified intervals
Time frame: data not collected due to early termination
Population: unable to perform final analysis due to early termination of study
Other Pre-specified
Scarring
Will assess using Vancouver Scar Scale
Time frame: data not collected due to early termination