Full Thickness Skin DefectsNCT01033604
Glyaderm + Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects
A study testing Glyaderm and split skin graft and Split skin graft alone. in people with Full Thickness Skin Defects, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Full Thickness Skin Defects
- What is being tested?
- Glyaderm and split skin graft and Split skin graft alone.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2007to Dec 2012
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with an expected healing time longer than 28 days. Dark blue color on the palette of the LDI software with flux values below 200
- All clearly full thickness burns on clinical assessment done by two plastic surgeons and thereafter treated with Flammacerium®.
- Wounds treated with a hydrocolloid paste prior to LDI and with low flux values < 200
- All assessments are done during first days before final decision at day three
- Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation on complete follow-up schedule
- Informed consent has been obtained
- TBSA Full Thickness Burn < 40%
Who cannot join
- All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with faster healing times ( flux values >200 )
- TBSA >40 %
- Not following the complete treatment schedule or missing some evaluations during the follow-up period
- Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
- Patient has participated in another study utilizing an investigational drug within the previous 30 days
- Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
- Patients wish to decline from the study
- No informed consent before start of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Application of a Novel Dermal Substitute Based on Glycerol Preserved Allograft: GLYADERM
The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns.
Patients with burn wounds or large full thickness wounds will be evaluated before enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a moist wound environment for the first 48 hours prior to assessment by LDI and randomization. This is the standard treatment for all burns admitted to the Ghent Burn Centre.
Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e. full thickness burns with LDI values < 200 will be randomized to receive either GLYADERM and split skin graft versus split skin graft alone.
- Conditions
- Full Thickness Skin Defects
- Being tested
- Glyaderm and split skin graft, Split skin graft alone.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyaderm and split skin graftProcedure or surgery
Full thickness defects treated with Glyaderm and split skin graft.
Split skin graft alone.Procedure or surgery
Full thickness defects treated with split skin graft alone.
| Study group | Role | What they receive |
|---|---|---|
| Glyaderm and split skin graft | Experimental | Full thickness defects treated with Glyaderm and split skin graft. Receives: Procedure: Glyaderm and split skin graft |
| Split skin graft alone | Active comparator | Full thickness defects treated with split skin graft alone. Receives: Procedure: Split skin graft alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of healing time and percentage of autograft survival
Measured: After one week
Comparison in bacterial control in full thickness defects
Measured: On day 3,5 an 7 post application of Glyaderm
To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging
Measured: On day 3, 5 and 7 post application of Glyaderm
Secondary outcomes (2)
To evaluate the functional and cosmetic outcome of skin restoration of full thickness defects treated with Glyaderm and split skin graft versus split skin graft alone
Measured: 1 month, 3, 6 and 12 months post wound closure
Cost-effectiveness and Health related quality of life (i.e. cost utility analysis)
Measured: 1 month, 3, 6 and 12 months post wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startSep 2007
- Primary completionFeb 2012
- Study completionDec 2012
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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Burnwound Foundation, Netherland
- Responsible party
- Sponsor
- Investigators
- Stan Monstrey, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033604
- Sponsor's protocol ID
- 2007/033
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2009
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
De Decker I, Hoeksema H, Verbelen J, De Coninck P, Speeckaert M, De Schepper S, Blondeel P, Pirayesh A, Monstrey S, Claes KEY. A single-stage bilayered skin reconstruction using Glyaderm(R) as an acellular dermal regeneration template results in improved scar quality: an intra-individual randomized controlled trial. Burns Trauma. 2023 May 2;11:tkad015. doi: 10.1093/burnst/tkad015. eCollection 2023.
PubMed 37143955
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Novel Dermal Substitute Based on Glycerol Preserved Allograft: GLYADERM
- ClinicalTrials.gov ID
- NCT01033604
- Acronym / sponsor ID
- 2007/033
- Conditions
- Full Thickness Skin Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Dutch Burnwound Foundation, Netherland
- Study start
- Sep 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Dec 2009 (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 application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal substitute would be affordable for widespread application in full thickness skin defects and burns.
Patients with burn wounds or large full thickness wounds will be evaluated before enrollment. All burn wounds that are not clearly full thickness on clinical assessment will be treated during the first 48 hours with a hydrocolloid paste and covered with a paraffin gauze dressing. This hydrocolloid paste combined with paraffin gauze will ensure maintenance of a moist wound environment for the first 48 hours prior to assessment by LDI and randomization. This is the standard treatment for all burns admitted to the Ghent Burn Centre.
Wounds will be photographed on a daily basis. In order to obtain an optimal preparation for LDI, the burn wounds will be meticulously debrided during dressing changes. LDI is most reliable between 48-72 hours. Patients whose burn wounds meet the inclusion criteria, i.e. full thickness burns with LDI values < 200 will be randomized to receive either GLYADERM and split skin graft versus split skin graft alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glyaderm and split skin graft | Experimental | Procedure: Glyaderm and split skin graftFull thickness defects treated with Glyaderm and split skin graft. |
| Split skin graft alone | Active comparator | Procedure: Split skin graft alone.Full thickness defects treated with split skin graft alone. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with an expected healing time longer than 28 days. Dark blue color on the palette of the LDI software with flux values below 200
- All clearly full thickness burns on clinical assessment done by two plastic surgeons and thereafter treated with Flammacerium®.
- Wounds treated with a hydrocolloid paste prior to LDI and with low flux values < 200
- All assessments are done during first days before final decision at day three
- Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation on complete follow-up schedule
Key exclusion criteria (8 listed)
- All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with faster healing times ( flux values >200 )
- TBSA >40 %
- Not following the complete treatment schedule or missing some evaluations during the follow-up period
- Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
- Patient has participated in another study utilizing an investigational drug within the previous 30 days
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 |
|---|---|---|
| Glyaderm and split skin graftFull thickness defects treated with Glyaderm and split skin graft. | Procedure or surgery | Glyaderm and split skin graft |
| Split skin graft alone.Full thickness defects treated with split skin graft alone. | Procedure or surgery | Split skin graft alone |
Primary outcome
Comparison of healing time and percentage of autograft survival
Time frame: After one week
Comparison in bacterial control in full thickness defects
Time frame: On day 3,5 an 7 post application of Glyaderm
To assess the monitoring of dermal substitute ingrowth with Laser Doppler Imaging
Time frame: On day 3, 5 and 7 post application of Glyaderm
2 secondary outcomes
To evaluate the functional and cosmetic outcome of skin restoration of full thickness defects treated with Glyaderm and split skin graft versus split skin graft alone
Time frame: 1 month, 3, 6 and 12 months post wound closure
Cost-effectiveness and Health related quality of life (i.e. cost utility analysis)
Time frame: 1 month, 3, 6 and 12 months post wound closure
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 5 Dec 2014.
- Derived from this study: PubMed 37143955De Decker I, Hoeksema H, Verbelen J, De Coninck P, Speeckaert M, De Schepper S, Blondeel P, Pirayesh A, Monstrey S, Claes KEY. A single-stage bilayered skin reconstruction using Glyaderm(R) as an acellular dermal regeneration template results in improved scar quality: an intra-individual randomized controlled trial. Burns Trauma. 2023 May 2;11:tkad015. doi: 10.1093/burnst/tkad015. eCollection 2023.
- website of the University Hospital GhentLink provided by the sponsor.
Related trials for Full Thickness Skin Defects
Not yet recruiting
Full-Thickness Skin Graft Sizing and Scar Quality
Full-Thickness Skin Graft Reconstruction of Nasal and Auricular Surgical 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.
Stan Monstrey, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glyaderm and split skin graft and Split skin graft alone. in people with Full Thickness Skin Defects, run by University Hospital, Ghent at 1 site in Belgium.
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 7 inclusion and 8 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 5 Dec 2014. 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 Belgium. 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?
Comparison of healing time and percentage of autograft survival (time frame: After one week). The study lists 3 primary outcomes in all. 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 NCT01033604, 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 5 Dec 2014.