BurnsNCT05189743
The Dermisgraft Epithelialization and Late Scar Healing
A study testing Skin transplantation to heal burn injuries in people with Burns, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Study Synopsis Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- Skin transplantation to heal burn injuries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 31 Jan 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Thermal \& chemical burns < 30 % TBSA
- Males \& females between 18-80 years old
- At least one coherent full thickness wound measuring 15 x 7.5 cm
- A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest.
Who cannot join
- Patients with severe cutaneous trauma at the same site as the burn injury
- Previous burns at the treatment site
- Severe cognitive dysfunction or psychiatric disorder
- Chronic skin disorder
- Chronic use of systemic or local corticosteroid
- Chronic use of anticoagulants or platelets
Show all 9Show fewer
- Autoimmune disease
- Active hepatitis
- Full thickness burns of head, genitalia, axilla or upper third of medial upper arm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
Study Synopsis
Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial
Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring.
Design; the study is a prospective, controlled clinical multicenter trial.
Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover.
Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.
Read the detailed description
Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG).
Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.
- Conditions
- Burns
- Being tested
- Skin transplantation to heal burn injuries
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin transplantation to heal burn injuriesProcedure or surgery
The study compare two different treatment modalities, STSG (split-thickness skin graft) versus dermis graft after excision of devitalized/necrotic tissue.
A dermatome will be used for graft harvest.
| Study group | Role | What they receive |
|---|---|---|
| Dermis graft | Experimental | Not described Receives: Procedure: Skin transplantation to heal burn injuries |
| STSG | Experimental | Not described Receives: Procedure: Skin transplantation to heal burn injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time
Recipient sites are to be assessed regarding healing (re-epithelization) at each site (donor respective recipient). Healing will be assesed in days after surgery.
Measured: 4 weeks
Aesthetic outcome
The aesthetic appereance regarding scarring will be assessed. A MPA580 cutometer will asses the viscoelasticity in the skin and POSAS will asses the appereance of the scar objectively as subjectively.
R0 and R2 will be used as variables evaluating firmness and elasticity.
POSAS will be analysed accoring to a scoring system (0-10 and 0-60).
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 posted12 Jan 2022
- Study start1 Feb 2017
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
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 BurnsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Folke Sjoberg, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189743
- Sponsor's protocol ID
- 2.4
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Dogan S, Elmasry M, El-Serafi A, Sjoberg F, Vuola J, Kankuri E, Grigoriadi MP, Valtonen J, Abdelrahman I, Steinvall I, Karlsson M, Olofsson P, Lindford A. A prospective dual-centre intra-individual controlled study for the treatment of burns comparing dermis graft with split-thickness skin auto-graft. Sci Rep. 2022 Dec 15;12(1):21666. doi: 10.1038/s41598-022-25346-4.
PubMed 36522434
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
- ClinicalTrials.gov ID
- NCT05189743
- Acronym / sponsor ID
- 2.4
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 12 Jan 2022 (actual)
- 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.
Study Synopsis
Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial
Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring.
Design; the study is a prospective, controlled clinical multicenter trial.
Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover.
Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.
Detailed description
Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG).
Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermis graft | Experimental | Procedure: Skin transplantation to heal burn injuries |
| STSG | Experimental | Procedure: Skin transplantation to heal burn injuries |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thermal \& chemical burns < 30 % TBSA
- Males \& females between 18-80 years old
- At least one coherent full thickness wound measuring 15 x 7.5 cm
- A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest.
Key exclusion criteria (9 listed)
- Patients with severe cutaneous trauma at the same site as the burn injury
- Previous burns at the treatment site
- Severe cognitive dysfunction or psychiatric disorder
- Chronic skin disorder
- Chronic use of systemic or local corticosteroid
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 |
|---|---|---|
| Skin transplantation to heal burn injuriesThe study compare two different treatment modalities, STSG (split-thickness skin graft) versus dermis graft after excision of devitalized/necrotic tissue. A dermatome will be used for graft harvest. | Procedure or surgery | Dermis graft, STSG |
Primary outcome
Healing time
Time frame: 4 weeks
Recipient sites are to be assessed regarding healing (re-epithelization) at each site (donor respective recipient). Healing will be assesed in days after surgery.
Aesthetic outcome
Time frame: 12 months
The aesthetic appereance regarding scarring will be assessed. A MPA580 cutometer will asses the viscoelasticity in the skin and POSAS will asses the appereance of the scar objectively as subjectively. R0 and R2 will be used as variables evaluating firmness and elasticity. POSAS will be analysed accoring to a scoring system (0-10 and 0-60).
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 12 Jan 2022.
- Derived from this study: PubMed 36522434Dogan S, Elmasry M, El-Serafi A, Sjoberg F, Vuola J, Kankuri E, Grigoriadi MP, Valtonen J, Abdelrahman I, Steinvall I, Karlsson M, Olofsson P, Lindford A. A prospective dual-centre intra-individual controlled study for the treatment of burns comparing dermis graft with split-thickness skin auto-graft. Sci Rep. 2022 Dec 15;12(1):21666. doi: 10.1038/s41598-022-25346-4.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin transplantation to heal burn injuries in people with Burns, run by University Hospital, Linkoeping at 1 site in Sweden.
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 4 inclusion and 9 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 12 Jan 2022. 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 Sweden. 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?
Healing time (time frame: 4 weeks). The study lists 2 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 NCT05189743, 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 12 Jan 2022.