Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/20/2018 |
Start Date: | June 15, 2018 |
End Date: | June 2020 |
Contact: | Lisa Clemons, MSN, RN |
Email: | lkclemons@uabmc.edu |
Phone: | 205-934-9714 |
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.
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.
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.
Inclusion Criteria:
- > 18 years of age
- participants are able to consent for themselves
- undergoing reconstructive surgery requiring split-thickness skin graft coverage of a
free flap donor site (i.e., radial forearm free flap or fibula free flap)
Exclusion Criteria:
- < 18 years of age
- participants are unable to consent for themselves
- undergoing reconstructive surgery that does not require split-thickness skin graft
coverage of a free flap donor site
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Principal Investigator: Brian Hughley, MD
Phone: 205-934-9714
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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