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Various management options for free flap donor sites that require split thickness skin grafting exist. None has proven superior from both a patient care and a cost standpoint. Major complications occurring at these surgical sites include wound breakdown, tendon exposure, and loss of function. We seek to investigate the use of the PICO single-use negative pressure wound therapy device in these surgical sites and determine if it can yield superior results to simpler methods.
Many studies have addressed the use of negative pressure wound therapy (NPWT) in free flap donor sites with mixed results. It is well established that NPWT is safe and causes no harm, and no delay in healing. A previous study performed at UAB showed that NPWT in complex Head & Neck Surgery reconstruction is safe, including free flap donor sites. There have been studies that state the rate of tendon exposure is lower with NPWT in free flap donor sites, and studies that conclude there is no difference in complication rates. Current clinical practice is varied, often within a single institution.
While no studies of NPWT in free flap donor sites have noted inferior results with its use, a primary reason cited for not using it is cost. Traditional NPWT using canister-based vacuum devices adds significant cost. The PICO single-use NPWT device (Smith & Nephew) is a relatively inexpensive, low-profile dressing that does not require attachment to an external canister. It is battery-powered and disposable. Empiric use on our patients undergoing split-thickness skin-grafting to free flap donor sites shows good results with minimal intra-operative effort compared to traditional bandaging. We would like to prospectively investigate the use of this low-cost NPWT device and compare it directly to the traditional post-op dressing method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| negative pressure wound therapy | Experimental | PICO Single Use Negative Pressure Wound Therapy System |
|
| conventional dressing | Placebo Comparator | traditional surgical wound dressing of xeroform gauze and padding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO Single Use Negative Pressure Wound Therapy System | Device | Class II negative pressure wound therapy powered suction pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression of Wound Healing | Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint. | Baseline through 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Greene, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Wound Therapy | PICO Single Use Negative Pressure Wound Therapy System PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump |
| FG001 | Conventional Dressing | traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Wound Therapy | PICO Single Use Negative Pressure Wound Therapy System PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump |
| BG001 | Conventional Dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression of Wound Healing | Comparison of photographs of all participants' wounds taken at post-operative Day 5, post-operative Day 14-21, and post-operative Day 30. Percentage skin graft take will be evaluated on Day 30 by blinded, independent raters. A 10x10 grid was digitally overlain on each image. The de-identified images were randomized and given to two independent raters. The raters used three criteria to assess each graft. Overall graft appearance was graded on a 1-5 scale, percent of graft take was estimated, and the presence of exposed tendon was noted for each timepoint. | Posted | Mean | Full Range | percentage of skin graft take | Baseline through 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Pressure Wound Therapy | PICO Single Use Negative Pressure Wound Therapy System PICO Single Use Negative Pressure Wound Therapy System: Class II negative pressure wound therapy powered suction pump |
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The patient population is small. Our statistics indicate that assuming an 80% graft take, the number of patients needed for an appropriately powered study (80%) would be 44 patients in each group, while our study recruited only 9 and 11 patients to each group. This study is limited by missing data. Our study also takes place at a single center and, therefore, surgeon technique must be taken into account as this may have affected the outcomes of our data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Greene, MD | University of Alabama at Birmingham | 205-801-7855 | bjgreene@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 21, 2017 | Jun 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| xeroform gauze | Device | traditional surgical dressing of xeroform gauze and padding |
|
traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Conventional Dressing | traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Conventional Dressing | traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding | 0 | 9 | 0 | 9 | 0 | 9 |
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