Surgical WoundNCT03340025
Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
A study testing PICO Single Use Negative Pressure Wound Therapy System and xeroform gauze in people with Surgical Wound, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound
- What is being tested?
- PICO Single Use Negative Pressure Wound Therapy System and xeroform gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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)
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Surgical Wound
- Being tested
- PICO Single Use Negative Pressure Wound Therapy System, xeroform gauze
- Keywords
- negative pressure wound therapy, split thickness skin graft
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO Single Use Negative Pressure Wound Therapy SystemDevice
Class II negative pressure wound therapy powered suction pump
xeroform gauzeDevice
traditional surgical dressing of xeroform gauze and padding
| Study group | Role | What they receive |
|---|---|---|
| negative pressure wound therapy | Experimental | PICO Single Use Negative Pressure Wound Therapy System Receives: Device: PICO Single Use Negative Pressure Wound Therapy System |
| conventional dressing | Placebo comparator | traditional surgical wound dressing of xeroform gauze and padding Receives: Device: xeroform gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start15 Jun 2018
- Primary completion13 Apr 2020
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Greene, University of Alabama at Birmingham
- Investigators
- Benjamin Greene, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340025
- Sponsor's protocol ID
- IRB-300000596
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2017
- Last updated
- 30 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Use Negative Pressure Wound Therapy for Free Flap Donor Sites
- ClinicalTrials.gov ID
- NCT03340025
- Acronym / sponsor ID
- IRB-300000596
- Conditions
- Surgical Wound
- Keywords
- negative pressure wound therapy, split thickness skin graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 30 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| negative pressure wound therapy | Experimental | Device: PICO Single Use Negative Pressure Wound Therapy SystemPICO Single Use Negative Pressure Wound Therapy System |
| conventional dressing | Placebo comparator | Device: xeroform gauzetraditional surgical wound dressing of xeroform gauze and padding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 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)
Key exclusion criteria (3 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO Single Use Negative Pressure Wound Therapy SystemClass II negative pressure wound therapy powered suction pump | Device | negative pressure wound therapy |
| xeroform gauzetraditional surgical dressing of xeroform gauze and padding | Device | conventional dressing |
Primary outcome
Progression of Wound Healing
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Greene, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO Single Use Negative Pressure Wound Therapy System and xeroform gauze in people with Surgical Wound, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Wound Healing (time frame: Baseline through 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.