Wound HealingPhase 4NCT01454310
An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns
A Phase 4 study testing Wound coverage by acellular skin substitute and Autologous skin in people with Wound Healing and Scar Formation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Scar Formation
- What is being tested?
- Wound coverage by acellular skin substitute and Autologous skin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients older than 18 years of age
- verified deep partial-thickness burns
- early tangential excision of burn wound (3-5 days after trauma)
Who cannot join
- Pregnancy
- ABSI-Score >13
- Active tumor or immune-mediated disease
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery
Vienna, State of Vienna, 1090
About this study
Official title: A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns
The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.
- Conditions
- Wound Healing, Scar Formation
- Being tested
- Wound coverage by acellular skin substitute, Autologous skin
- Keywords
- Skin substitutes, Split-thickness skin graft, Burn wound, Scar formation, Skin quality
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound coverage by acellular skin substituteDevice
Also called Suprathel
Burn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation
Autologous skinDevice
Matched burn wound is covered by autologous skin after tangential excision.
| Study group | Role | What they receive |
|---|---|---|
| Acellular skin substitute | Experimental | Not described Receives: Device: Wound coverage by acellular skin substitute |
| Autologous skin graft | Active comparator | Not described Receives: Device: Autologous skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin
Time to complete re-epithelialisation measured in days after surgery
Measured: 1 year
Secondary outcomes (1)
Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin
Quality of the skin is measured two-fold:
- Subjective scar scors: Vancouver Scar Scale, Patient and Observer Scar Scale
- Objective scar evaluation by a non-invasive suction device, that measures viscoelastic parameter.
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 posted19 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald Franz Selig, Medical University of Vienna
- Investigators
- Lars P Kamolz, MD, PhD, MSc, Study chair, Medical University of ViennaMaike Keck, MD, Principal investigator, Medical University of Vienna, Department of Plastic and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454310
- Sponsor's protocol ID
- SUPRA-VS-STSG-2010
- Status last verified
- Oct 2011
- First submitted
- 15 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. doi: 10.1016/j.burns.2006.04.024. Epub 2006 Nov 2.
PubMed 17084030
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns
- ClinicalTrials.gov ID
- NCT01454310
- Acronym / sponsor ID
- SUPRA-VS-STSG-2010
- Conditions
- Wound Healing, Scar Formation
- Keywords
- Skin substitutes, Split-thickness skin graft, Burn wound, Scar formation, Skin quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
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 the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acellular skin substitute | Experimental | Device: Wound coverage by acellular skin substitute |
| Autologous skin graft | Active comparator | Device: Autologous skin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years of age
- verified deep partial-thickness burns
- early tangential excision of burn wound (3-5 days after trauma)
Key exclusion criteria (4 listed)
- Pregnancy
- ABSI-Score >13
- Active tumor or immune-mediated disease
- Patient refusal
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 |
|---|---|---|
| Wound coverage by acellular skin substituteAlso: SuprathelBurn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation | Device | Acellular skin substitute |
| Autologous skinMatched burn wound is covered by autologous skin after tangential excision. | Device | Autologous skin graft |
Primary outcome
Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin
Time frame: 1 year
Time to complete re-epithelialisation measured in days after surgery
1 secondary outcome
Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
- Background: PubMed 17084030Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. doi: 10.1016/j.burns.2006.04.024. Epub 2006 Nov 2.
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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.
Lars P Kamolz, MD, PhD, MSc study chair
Medical University of Vienna
Maike Keck, MD principal investigator
Medical University of Vienna, Department of Plastic and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wound coverage by acellular skin substitute and Autologous skin in people with Wound Healing and Scar Formation, run by Medical University of Vienna at 1 site in Austria.
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 4 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 19 Oct 2011. 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01454310, which also lists 1 linked publication.
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 19 Oct 2011.