BurnsPhase 3NCT00609908
The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction
A Phase 3 study testing Split skin graft, skin stretching device and serial excision in people with Burns and Scars, run by Association of Dutch Burn Centres at 1 site in Netherlands.
Trial summary
Objective: A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories: 1. acute burn wounds: wound closure by means of skin stretching should lead to a significant reduction of scar surface area in comparison to the standard technique, the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Split skin graft, skin stretching device and serial excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2007to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute Burn wounds or scar reconstructions that require surgical treatment;
- Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure;
- Age >= 18 years.
Who cannot join
- Language barrier;
- Known history of keloid formation;
- Systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
- Local or systemic application of corticosteroids;
- Psychiatric diseases leading to study bias (e.g. automutilation);
- Skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
- Radiated skin;
- Wound located at extremities, exceeding >33% of circumference (acute burn category).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction: Clinical Applications and Working Mechanisms.
Objective:
A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories:
Read more
- acute burn wounds: wound closure by means of skin stretching should lead to a significant reduction of scar surface area in comparison to the standard technique, the split skin grafting;
- scar reconstructions: wound closure by means of skin stretching during one operative procedure should lead to a comparable scar surface in comparison to the multiple procedures techniques such as serial excision.
Study design:
Skin stretching will be compared to split skin grafting and should result in burn wound closure with significantly smaller scars. Also, a comparison will be made between the technique of serial excision versus skin stretching for scar reconstructions.
Scar evaluation three and twelve months after surgery will include the following parameters:
- surface area;
- Patient and Observer Scar Assessment Scale (POSAS);
- elasticity;
- vascularization and pigmentation;
- thickness;
- dermal architecture.
After 12 months adults will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the skin stretcher will undergo one extra biopsy of the formerly stretched skin.
Intervention:
At the start of the operation will be determined by randomization if skin stretching or split skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be performed.
Read the detailed description
Eligibility criteria:
Inclusion:
- Acute Burn wounds or scar reconstructions that require surgical treatment; 2. Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure.
- Age >= 18 years
Exclusion:
- language barrier;
- known history of keloid formation;
- systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
- local or systemic application of corticosteroids;
- psychiatric diseases leading to study bias (e.g. automutilation);
- skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
- radiated skin;
- wound located at extremities, exceeding >33% of circumference (acute burn category);
Primary study parameters/outcome of the study:
The primary study parameter is the surface area of the scar after 12 months
Secondary study parameters/outcome of the study (if applicable):
All scars will also be subjected to the scar evaluation protocol after 3 and 12 months by an independent observer for the evaluation of the:
- patient and observer scar assessment scale (POSAS);
- scar elasticity (Cutometer);
- scar vascularisation \& pigmentation (DermaSpectrometer);
- scar thickness (histopathology, only after 12 months).
Punch biopsies are taken for morphometry of dermal architecture (Fourier analysis). During surgery one biopsy is obtained of the normal skin. In the experimental group an additional biopsy is obtained at the end of the stretching procedure in order to be able to compare structure of the dermal matrix and orientation of the collagen fibers.
After 1 year, one biopsy is taken from the scar. The experimental group will undergo one additional biopsy of the formerly stretched skin.
- Being tested
- Split skin graft, skin stretching device, serial excision
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split skin graftProcedure or surgery
After wound bed preparation the skin defect is covered with a skin transplant (split skin graft)
skin stretching deviceProcedure or surgery
after woundbed preparation the wound is primarily closed by aid of the skin stretching device
serial excisionProcedure or surgery
as much scar as possible is excised, whereafter the wound is closed
skin stretching deviceProcedure or surgery
after the scar is excised, the wound is primarily closed by aid of the skin stretching device
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Acute Burn Wounds: Wound debridement and split skin grafting Receives: Procedure: Split skin graft |
| A2 | Experimental | Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device Receives: Procedure: skin stretching device |
| B1 | Active comparator | Scar reconstruction: serial excision Receives: Procedure: serial excision |
| B2 | Experimental | Scar reconstruction: primary closure, using skin stretching device Receives: Procedure: skin stretching device |
What is being measured
The primary outcome is the main question the study is designed to answer.
the surface area of the scar after 12 months
Measured: 3 and 12 months after surgery
Secondary outcomes (1)
scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness
Measured: 3 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2011
- Study completionJun 2011
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association of Dutch Burn Centres
- Sponsor type
- University, hospital or other
- Investigators
- E Middelkoop, Professor, Principal investigator, VU MCP.P.M. van Zuijlen, MD, PhD, Study director, Red Cross Hospital Beverwijk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609908
- Sponsor's protocol ID
- 06.201
- Other IDs
- 06.201
- Status last verified
- Jun 2015
- First submitted
- 25 Jan 2008
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction: Clinical Applications and Working Mechanisms.
- ClinicalTrials.gov ID
- NCT00609908
- Acronym / sponsor ID
- 06.201
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Association of Dutch Burn CentresUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Feb 2008 (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.
Objective:
A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories:
- acute burn wounds: wound closure by means of skin stretching should lead to a significant reduction of scar surface area in comparison to the standard technique, the split skin grafting;
- scar reconstructions: wound closure by means of skin stretching during one operative procedure should lead to a comparable scar surface in comparison to the multiple procedures techniques such as serial excision.
Study design:
Skin stretching will be compared to split skin grafting and should result in burn wound closure with significantly smaller scars. Also, a comparison will be made between the technique of serial excision versus skin stretching for scar reconstructions.
Scar evaluation three and twelve months after surgery will include the following parameters:
- surface area;
- Patient and Observer Scar Assessment Scale (POSAS);
- elasticity;
- vascularization and pigmentation;
- thickness;
- dermal architecture.
After 12 months adults will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the skin stretcher will undergo one extra biopsy of the formerly stretched skin.
Intervention:
At the start of the operation will be determined by randomization if skin stretching or split skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be performed.
Detailed description
Eligibility criteria:
Inclusion:
- Acute Burn wounds or scar reconstructions that require surgical treatment; 2. Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure.
- Age >= 18 years
Exclusion:
- language barrier;
- known history of keloid formation;
- systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
- local or systemic application of corticosteroids;
- psychiatric diseases leading to study bias (e.g. automutilation);
- skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
- radiated skin;
- wound located at extremities, exceeding >33% of circumference (acute burn category);
Primary study parameters/outcome of the study:
The primary study parameter is the surface area of the scar after 12 months
Secondary study parameters/outcome of the study (if applicable):
All scars will also be subjected to the scar evaluation protocol after 3 and 12 months by an independent observer for the evaluation of the:
- patient and observer scar assessment scale (POSAS);
- scar elasticity (Cutometer);
- scar vascularisation \& pigmentation (DermaSpectrometer);
- scar thickness (histopathology, only after 12 months).
Punch biopsies are taken for morphometry of dermal architecture (Fourier analysis). During surgery one biopsy is obtained of the normal skin. In the experimental group an additional biopsy is obtained at the end of the stretching procedure in order to be able to compare structure of the dermal matrix and orientation of the collagen fibers.
After 1 year, one biopsy is taken from the scar. The experimental group will undergo one additional biopsy of the formerly stretched skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Procedure: Split skin graftAcute Burn Wounds: Wound debridement and split skin grafting |
| A2 | Experimental | Procedure: skin stretching deviceAcute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device |
| B1 | Active comparator | Procedure: serial excisionScar reconstruction: serial excision |
| B2 | Experimental | Procedure: skin stretching deviceScar reconstruction: primary closure, using skin stretching device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute Burn wounds or scar reconstructions that require surgical treatment;
- Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure;
- Age >= 18 years.
Key exclusion criteria (8 listed)
- Language barrier;
- Known history of keloid formation;
- Systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
- Local or systemic application of corticosteroids;
- Psychiatric diseases leading to study bias (e.g. automutilation);
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 |
|---|---|---|
| Split skin graftAfter wound bed preparation the skin defect is covered with a skin transplant (split skin graft) | Procedure or surgery | A1 |
| skin stretching deviceafter woundbed preparation the wound is primarily closed by aid of the skin stretching device | Procedure or surgery | A2 |
| serial excisionas much scar as possible is excised, whereafter the wound is closed | Procedure or surgery | B1 |
| skin stretching deviceafter the scar is excised, the wound is primarily closed by aid of the skin stretching device | Procedure or surgery | B2 |
Primary outcome
the surface area of the scar after 12 months
Time frame: 3 and 12 months after surgery
1 secondary outcome
scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness
Time frame: 3 and 12 months after surgery
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 26 Jun 2015.
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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, Professor principal investigator
VU MC
P.P.M. van Zuijlen, MD, PhD study director
Red Cross Hospital Beverwijk
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 Split skin graft, skin stretching device and serial excision in people with Burns and Scars, 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 3 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 26 Jun 2015. 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?
the surface area of the scar after 12 months (time frame: 3 and 12 months after surgery). 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 26 Jun 2015.