BurnsPhase 3KCNCT00832156
Application of Cultured Autologous Keratinocytes for Burn Wound Healing
A Phase 3 study testing Cultured autologous keratinocytes in people with Burns, run by Association of Dutch Burn Centres at 1 site in Netherlands.
Trial summary
In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Cultured autologous keratinocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2008to Sep 2013
- Phase
- Phase 3
- 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
- Competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision
- Minimal study wound area 100 cm2
- Maximal study wound area 300 cm2
- Maximal TBSA 30% full thickness wounds
- Informed consent
Who cannot join
- Immunocompromised patients
- Infected wounds
- Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica
- Known penicillin allergy
- Conditions where the patient is non compliant as judged by a medical specialist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing
In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. It is expected that the application of cultured autologous keratinocytes in combination with a meshed split skin autograft will improve wound healing and scar formation.
Read the detailed description
The standard treatment for extensive burn wounds is transplantation with meshed split skin graft. Disadvantages of this treatment are that healing of large full thickness burn wounds is still accompanied by scar formation. Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure and improve outcome of healing.
Primary objective: Does the application of cultured autologous keratinocytes on deep burn wounds accelerate wound closure Secondary objectives: Does the application of cultured autologous keratinocytes on deep burn wounds improve scar quality with respect to scar elasticity, colour/pigmentation and/or smoothness after 3 and 12 months.
- Conditions
- Burns
- Being tested
- Cultured autologous keratinocytes
- Keywords
- Burns, Cultured autologous keratinocytes, Wound healing, Wound closure, Scar quality
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured autologous keratinocytesBiological
Also called Cultured keratinocytes
The experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | wound 1: the placement of keratinocytes onto a collagen/elastin support after the application of the meshed split skin autograft. Receives: Biological: Cultured autologous keratinocytes |
| 2 | Other | control wound site; application of mesh graft alone Receives: Biological: Cultured autologous keratinocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end point is the percentage of wound closure.
Measured: 7 days
Secondary outcomes (1)
Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E Middelkoop, Prof, Study director, Association of Dutch Burn Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832156
- Sponsor's protocol ID
- NBS 07.116 KC
- Other IDs
- NL19048.000.07
- Acronym
- KC
- Status last verified
- Jun 2014
- First submitted
- 28 Jan 2009
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
- Application of Cultured Autologous Keratinocytes in Combination With a Meshed Split Skin Autograft for Burn Wound Healing
- ClinicalTrials.gov ID
- NCT00832156
- Acronym / sponsor ID
- KC / NBS 07.116 KC
- Conditions
- Burns
- Keywords
- Burns, Cultured autologous keratinocytes, Wound healing, Wound closure, Scar quality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Jan 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.
In this study the treatment of full thickness burn wounds with cultured autologous keratinocytes in combination with meshed split skin autograft versus meshed split skin graft alone will be compared. It is expected that the application of cultured autologous keratinocytes in combination with a meshed split skin autograft will improve wound healing and scar formation.
Detailed description
The standard treatment for extensive burn wounds is transplantation with meshed split skin graft. Disadvantages of this treatment are that healing of large full thickness burn wounds is still accompanied by scar formation. Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure and improve outcome of healing.
Primary objective: Does the application of cultured autologous keratinocytes on deep burn wounds accelerate wound closure Secondary objectives: Does the application of cultured autologous keratinocytes on deep burn wounds improve scar quality with respect to scar elasticity, colour/pigmentation and/or smoothness after 3 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Cultured autologous keratinocyteswound 1: the placement of keratinocytes onto a collagen/elastin support after the application of the meshed split skin autograft. |
| 2 | Other | Biological: Cultured autologous keratinocytescontrol wound site; application of mesh graft alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision
- Minimal study wound area 100 cm2
- Maximal study wound area 300 cm2
- Maximal TBSA 30% full thickness wounds
- Informed consent
Key exclusion criteria (5 listed)
- Immunocompromised patients
- Infected wounds
- Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica
- Known penicillin allergy
- Conditions where the patient is non compliant as judged by a medical specialist
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 |
|---|---|---|
| Cultured autologous keratinocytesAlso: Cultured keratinocytesThe experimental wound site will be covered with cultured keratinocytes on a collagen/elastin carrier after the application of a meshed split skin autograft. The control wound site will be covered with a meshed split skin autograft alone. | Biological | 1, 2 |
Primary outcome
Primary end point is the percentage of wound closure.
Time frame: 7 days
1 secondary outcome
Secondary objective is scar quality (i.e. subjective scar assessment, scar elasticity, colour and pigmentation of the scar and smoothness of the scar surface).
Time frame: 3 and 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.
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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.
E Middelkoop, Prof study director
Association of Dutch Burn Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cultured autologous keratinocytes in people with Burns, run by Association of Dutch Burn Centres at 1 site in Netherlands.
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 5 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 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary end point is the percentage of wound closure. (time frame: 7 days). 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 17 Feb 2020.