Full Thickness Skin DefectsNCT02164760
The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars
A study testing Novomaix dermal substitute in combination with STSG in people with Full Thickness Skin Defects, run by Association of Dutch Burn Centres at 2 sites in 2 countries.
Trial summary
In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full Thickness Skin Defects
- What is being tested?
- Novomaix dermal substitute in combination with STSG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- 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
- Age ≥18 years
- with acute burns/trauma wounds that require skin grafting (group 1) OR
- with scar problems requiring surgical treatment (group 2)
- Full thickness skin defects of 50 cm2 or more, but <50% TBSA
- Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
- Informed consent by the patient
Who cannot join
- Patients with infected wounds
- Pregnant or breast feeding females
- Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
- Known allergy against porcine collagen or elastin
- Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- Previous enrolment of the patient into the current study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
Berlin, 12683
About this study
Official title: A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.
In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.
Read the detailed description
Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.
- Conditions
- Full Thickness Skin Defects
- Being tested
- Novomaix dermal substitute in combination with STSG
- Keywords
- burns, dermal substitute, scar quality, reconstruction, wound healing, wound closure
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novomaix dermal substitute in combination with STSGDevice
Also called Novomaix
Novomaix dermal substitute in combination with STSG
| Study group | Role | What they receive |
|---|---|---|
| Dermal substitute with STSG | Experimental | Novomaix dermal substitute in combination with STSG Receives: Device: Novomaix dermal substitute in combination with STSG |
| STSG alone | No intervention | STSG alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft take (experimental vs control area)
Subjective assessment of two experienced observers
Measured: 5-7 days postoperative
Secondary outcomes (6)
Epithelialization
Subjective assessment of two experienced observers
Measured: 5-7 and 18 ± 2 days days postoperative
Complication rate
Measurement of re-operations, infection rate by culture swabs
Measured: Up to 12 months postoperative
Scar quality
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
Measured: 3 months
Scar quality
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
Measured: 6 months
Scar quality
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
Measured: 9 months
Scar quality
As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionJun 2016
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 Full Thickness Skin DefectsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Collaborators
- Ernst Reichmann Tissue Biology Research Unit, Zürich, Seventh Framework Programme
- Responsible party
- Sponsor
- Investigators
- Esther Middelkoop, Prof. dr., Principal investigator, Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164760
- Sponsor's protocol ID
- ESG-09-2012
- Other IDs
- NL42113.094.12
- Status last verified
- Feb 2020
- First submitted
- 11 Jun 2014
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1.
PubMed 24178984
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.
- ClinicalTrials.gov ID
- NCT02164760
- Acronym / sponsor ID
- ESG-09-2012
- Conditions
- Full Thickness Skin Defects
- Keywords
- burns, dermal substitute, scar quality, reconstruction, wound healing, wound closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Collaborators
- Ernst Reichmann Tissue Biology Research Unit, Zürich, Seventh Framework Programme
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Jun 2014 (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.
In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.
Detailed description
Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermal substitute with STSG | Experimental | Device: Novomaix dermal substitute in combination with STSGNovomaix dermal substitute in combination with STSG |
| STSG alone | No intervention | –STSG alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Full thickness skin defects of 50 cm2 or more, but <50% TBSA
- Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
- Informed consent by the patient
Key exclusion criteria (6 listed)
- Patients with infected wounds
- Pregnant or breast feeding females
- Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
- Known allergy against porcine collagen or elastin
- Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
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 |
|---|---|---|
| Novomaix dermal substitute in combination with STSGAlso: NovomaixNovomaix dermal substitute in combination with STSG | Device | Dermal substitute with STSG |
Primary outcome
Graft take (experimental vs control area)
Time frame: 5-7 days postoperative
Subjective assessment of two experienced observers
6 secondary outcomes
Epithelialization
Time frame: 5-7 and 18 ± 2 days days postoperative
Complication rate
Time frame: Up to 12 months postoperative
Scar quality
Time frame: 3 months
Scar quality
Time frame: 6 months
Scar quality
Time frame: 9 months
Scar quality
Time frame: 12 months
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 17 Feb 2020.
- Background: PubMed 24178984Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1.
Related trials for Full Thickness Skin Defects
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
RecruitingObservational study
Clinical and Histological Study of a Novel Dermal Substitute
Skin Transplantation
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.
Esther Middelkoop, Prof. dr. principal investigator
Red Cross Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novomaix dermal substitute in combination with STSG in people with Full Thickness Skin Defects, run by Association of Dutch Burn Centres at 2 sites in 2 countries.
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 6 inclusion and 6 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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?
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?
Graft take (experimental vs control area) (time frame: 5-7 days postoperative). 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 NCT02164760, 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 17 Feb 2020.