Head and Neck CancerNCT02980601
The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
A study testing Integra plus STSG and STSG in people with Head and Neck Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Integra plus STSG and STSG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 6 Aug 2018
- 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
- All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction.
- Have had a distal, anterograde fasciocutaneous flap
- Age ≥ 18 years
- Ability to understand and the willingness to sign an IRB-approved informed consent document.
- Smokers and tobacco users will be included in this study
Who cannot join
- Subjects who have had an osteocutaneous or musculocutaneous flap.
- Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a "reverse" radial forearm flap
- Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA template in pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.
Read the detailed description
The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon after established as a safe and reliable flap for transfer of fascia and cutaneous tissue. Currently, it is used to repair any defect in which a relatively thin island of skin is needed with a fascial strength layer . While the flap itself is very reliable, it leaves a donor site that can be very unsightly and has multiple known complications including loss of pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is typically covered with a split thickness skin graft (hereafter referred to as STSG). In an effort to minimize these complications, several groups have described a technique of placing Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide a thicker support and decrease overall morbidity associated with the defect. These studies have shown success in decreasing overall morbidity including increasing range of motion and improving aesthetic quality of the donor site. However, the largest study to date has included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of subjects repaired with a classic STSG to show effectiveness of this technique when compared to a classic repair. Our goal is to perform a prospective study comparing subjects repaired with a classic STSG and those repaired with one step Integra and STSG applied at the same time. These subjects will be evaluated for overall donor site aesthetic quality and functional outcome as described below.
- Conditions
- Head and Neck Cancer
- Being tested
- Integra plus STSG, STSG
- Keywords
- Traumatic Defect, Chronic Wounds
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integra plus STSGDevice
A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG
STSGProcedure or surgery
0.012mm STSG
| Study group | Role | What they receive |
|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Experimental | A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. Receives: Device: Integra plus STSG; Procedure: STSG |
| Split Thickness Skin Graft (STSG) | Active comparator | reconstruction as dictated by the protocol. They will either receive 1) a 0 Receives: Procedure: STSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Skin Graft Necrosis.
Number of participants with skin graft necrosis.
Measured: 1 year
Vancouver Scar Scale
The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.
Measured: 1 Year
Vancouver Scar Scale - Pigmentation
Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.
Measured: 1 year
Vancouver Scar Scale - Vascularity
Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.
Measured: 1 year
Vancouver Scar Scale - Pliability
Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.
Measured: 1 year
Vancouver Scar Scale - Height
Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.
Measured: 1 year
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Measured: Pre-op
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Measured: 3 month
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Measured: 6 months
Hand Strength -Lateral Pinch
Functional outcomes will be measured by using strength dynamometers.
Measured: 1 year
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Measured: pre-op
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Measured: 3 month
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Measured: 6 month
Hand Strength - Grip
Functional outcomes will be measured by using strength dynamometers.
Measured: 1 year
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Measured: pre-op
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Measured: 3 month
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Measured: 6 month
Hand Strength- Pincer
Functional outcomes will be measured by using strength dynamometers
Measured: 1 year
Wrist Range of Motion- Flexion
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: pre-op
Wrist Range of Motion- Flexion
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: 3 month
Wrist Range of Motion- Flexion
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: 6 month
Wrist Range of Motion- Flexion
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: 1 year
Wrist Range of Motion- Extension
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: pre-op
Wrist Range of Motion- Extension
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: 3 month
Wrist Range of Motion- Extension
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: 6 month
Wrist Range of Motion- Extension
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Measured: 1 year
Number of Participant With Tendon Exposure
Tendon exposure identified clinically.
Measured: 6 month
Rate of Tendon Exposure
Tendon exposure identified clinically.
Measured: 1 year
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Measured: 3 month
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Measured: 6 month
Patient Scar Assessment- Paresthesia
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Measured: 1 year
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
Measured: pre-op
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
Measured: 3 month
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
Measured: 6 month
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
Measured: 1 year
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Measured: 3 month
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Measured: 6 month
Percent of Wound Contracture
Planimetry Software will be used to measure and determine percentage of wound contracture
Measured: 1 year
Skin Pliability
Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2015
- Primary completion18 Aug 2017
- Study completion6 Aug 2018
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 Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Molnar, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980601
- Sponsor's protocol ID
- IRB00031531
- Other IDs
- CCCWFU 99915A
- Status last verified
- May 2019
- First submitted
- 29 Nov 2016
- Last updated
- 24 May 2019
- 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 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
- ClinicalTrials.gov ID
- NCT02980601
- Acronym / sponsor ID
- IRB00031531
- Conditions
- Head and Neck Cancer
- Keywords
- Traumatic Defect, Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 24 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare the forearm free flap of patients with a traditional split thickness skin graft and those repaired with Integra (a skin substitute that helps to provide wound closure) and a split thickness skin graft. The study team will be looking at the subject's satisfaction with how the skin graft site looks and how well the skin graft site is functioning.
Detailed description
The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described more than 30 years ago as a fasciocutaneous flap for microsurgical transfer. It was soon after established as a safe and reliable flap for transfer of fascia and cutaneous tissue. Currently, it is used to repair any defect in which a relatively thin island of skin is needed with a fascial strength layer . While the flap itself is very reliable, it leaves a donor site that can be very unsightly and has multiple known complications including loss of pronation, pain, paresthesias, cold intolerance, and skin graft necrosis. The donor site is typically covered with a split thickness skin graft (hereafter referred to as STSG). In an effort to minimize these complications, several groups have described a technique of placing Integra© dermal substitute (hereafter referred to as Integra) underneath the STSG to provide a thicker support and decrease overall morbidity associated with the defect. These studies have shown success in decreasing overall morbidity including increasing range of motion and improving aesthetic quality of the donor site. However, the largest study to date has included only 29 subjects. Furthermore, these studies do not provide a comparative cohort of subjects repaired with a classic STSG to show effectiveness of this technique when compared to a classic repair. Our goal is to perform a prospective study comparing subjects repaired with a classic STSG and those repaired with one step Integra and STSG applied at the same time. These subjects will be evaluated for overall donor site aesthetic quality and functional outcome as described below.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integra and a Split Thickness Skin Graft (STSG) | Experimental | Device: Integra plus STSG, Procedure: STSGA sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG. |
| Split Thickness Skin Graft (STSG) | Active comparator | Procedure: STSGreconstruction as dictated by the protocol. They will either receive 1) a 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects who receive a radial forearm free flaps in the included time period, including subjects with head and neck cancer, traumatic defects, chronic wounds, or any other problems that require a radical forearm free flap for reconstruction.
- Have had a distal, anterograde fasciocutaneous flap
- Age ≥ 18 years
- Ability to understand and the willingness to sign an IRB-approved informed consent document.
- Smokers and tobacco users will be included in this study
Key exclusion criteria (3 listed)
- Subjects who have had an osteocutaneous or musculocutaneous flap.
- Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a "reverse" radial forearm flap
- Pregnant women will be excluded due to the lack of clinical studies evaluating INTEGRA template in pregnant women.
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 |
|---|---|---|
| Integra plus STSGA sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG | Device | Integra and a Split Thickness Skin Graft (STSG) |
| STSG0.012mm STSG | Procedure or surgery | Integra and a Split Thickness Skin Graft (STSG), Split Thickness Skin Graft (STSG) |
Primary outcome
Number of Participants With Skin Graft Necrosis.
Time frame: 1 year
Number of participants with skin graft necrosis.
Vancouver Scar Scale
Time frame: 1 Year
The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.
Vancouver Scar Scale - Pigmentation
Time frame: 1 year
Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.
Vancouver Scar Scale - Vascularity
Time frame: 1 year
Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.
Vancouver Scar Scale - Pliability
Time frame: 1 year
Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.
Vancouver Scar Scale - Height
Time frame: 1 year
Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.
Hand Strength -Lateral Pinch
Time frame: Pre-op
Functional outcomes will be measured by using strength dynamometers.
Hand Strength -Lateral Pinch
Time frame: 3 month
Functional outcomes will be measured by using strength dynamometers.
Hand Strength -Lateral Pinch
Time frame: 6 months
Functional outcomes will be measured by using strength dynamometers.
Hand Strength -Lateral Pinch
Time frame: 1 year
Functional outcomes will be measured by using strength dynamometers.
Hand Strength - Grip
Time frame: pre-op
Functional outcomes will be measured by using strength dynamometers.
Hand Strength - Grip
Time frame: 3 month
Functional outcomes will be measured by using strength dynamometers.
Hand Strength - Grip
Time frame: 6 month
Functional outcomes will be measured by using strength dynamometers.
Hand Strength - Grip
Time frame: 1 year
Functional outcomes will be measured by using strength dynamometers.
Hand Strength- Pincer
Time frame: pre-op
Functional outcomes will be measured by using strength dynamometers
Hand Strength- Pincer
Time frame: 3 month
Functional outcomes will be measured by using strength dynamometers
Hand Strength- Pincer
Time frame: 6 month
Functional outcomes will be measured by using strength dynamometers
Hand Strength- Pincer
Time frame: 1 year
Functional outcomes will be measured by using strength dynamometers
Wrist Range of Motion- Flexion
Time frame: pre-op
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Flexion
Time frame: 3 month
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Flexion
Time frame: 6 month
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Flexion
Time frame: 1 year
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Extension
Time frame: pre-op
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Extension
Time frame: 3 month
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Extension
Time frame: 6 month
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Wrist Range of Motion- Extension
Time frame: 1 year
Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension
Number of Participant With Tendon Exposure
Time frame: 6 month
Tendon exposure identified clinically.
Rate of Tendon Exposure
Time frame: 1 year
Tendon exposure identified clinically.
Patient Scar Assessment- Paresthesia
Time frame: 3 month
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Patient Scar Assessment- Paresthesia
Time frame: 6 month
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
Patient Scar Assessment- Paresthesia
Time frame: 1 year
Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Time frame: pre-op
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Time frame: 3 month
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Time frame: 6 month
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)
Time frame: 1 year
Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure
Percent of Wound Contracture
Time frame: 3 month
Planimetry Software will be used to measure and determine percentage of wound contracture
Percent of Wound Contracture
Time frame: 6 month
Planimetry Software will be used to measure and determine percentage of wound contracture
Percent of Wound Contracture
Time frame: 1 year
Planimetry Software will be used to measure and determine percentage of wound contracture
Skin Pliability
Time frame: 1 year
Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Joseph Molnar, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integra plus STSG and STSG in people with Head and Neck Cancer, run by Wake Forest University Health Sciences 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 5 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: stopped early, as of the sponsor's last update on 24 May 2019. 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. 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 24 May 2019). 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?
Number of Participants With Skin Graft Necrosis. (time frame: 1 year). The study lists 39 primary outcomes in all. 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 24 May 2019.