Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03340025
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound	Device: PICO Single Use Negative Pressure Wound Therapy System; Device: xeroform gauze	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
• Actual Study Start Date: Jun 15, 2018
• Actual Primary Completion Date: Apr 13, 2020
• Actual Study Completion Date: Jun 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: negative pressure wound therapy PICO Single Use Negative Pressure Wound Therapy System	Device: PICO Single Use Negative Pressure Wound Therapy System; Class II negative pressure wound therapy powered suction pump
Placebo Comparator: conventional dressing traditional surgical wound dressing of xeroform gauze and padding	Device: xeroform gauze; traditional surgical dressing of xeroform gauze and padding

Outcome Measures

Primary Outcome Measures

1. Progression of Wound Healing [Baseline through 30 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Benjamin Greene, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 21, 2017

More Information

Publications

None provided.

• Responsible Party: Benjamin Greene, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03340025
• Other Study ID Numbers: IRB-300000596
• First Posted: Nov 13, 2017
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Benjamin Greene, Principal Investigator, University of Alabama at Birmingham: negative pressure wound therapy; split thickness skin graft
• Additional relevant MeSH terms: Wounds and Injuries; Surgical Wound

Study Results

Participant Flow

Arm/Group Title	Negative Pressure Wound Therapy	Conventional Dressing
Arm/Group Description	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	traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding
Period Title: Overall Study
STARTED	11	9
COMPLETED	9	7
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Negative Pressure Wound Therapy	Conventional Dressing	Total
Arm/Group Description	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	traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding	Total of all reporting groups
Overall Participants	11	9	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	6 54.5%	5 55.6%	11 55%
>=65 years	5 45.5%	4 44.4%	9 45%
Sex: Female, Male (Count of Participants)
Female	4 36.4%	1 11.1%	5 25%
Male	7 63.6%	8 88.9%	15 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 9.1%	0 0%	1 5%
White	10 90.9%	9 100%	19 95%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	11 100%	9 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Progression of Wound Healing
Description	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.
Time Frame	Baseline through 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Negative Pressure Wound Therapy	Conventional Dressing
Arm/Group Description	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	traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding
Measure Participants	9	7
Mean (Full Range) [percentage of skin graft take]	69.9	75.6

Adverse Events

Time Frame	30 days
Arm/Group Title	Negative Pressure Wound Therapy		Conventional Dressing
Arm/Group Description	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		traditional surgical wound dressing of xeroform gauze and padding xeroform gauze: traditional surgical dressing of xeroform gauze and padding
All Cause Mortality
	Negative Pressure Wound Therapy		Conventional Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/9 (0%)
Serious Adverse Events
	Negative Pressure Wound Therapy		Conventional Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Negative Pressure Wound Therapy		Conventional Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/9 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.