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| ID | Type | Description | Link |
|---|---|---|---|
| 06.201 |
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Objective:
A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories:
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:
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.
Eligibility criteria:
Inclusion:
1. 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.
3. Age >= 18 years
Exclusion:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Active Comparator | Acute Burn Wounds: Wound debridement and split skin grafting |
|
| A2 | Experimental | Acute Burn Wounds: excision of the burn wound and primary closure, using a skin stretching device |
|
| B1 | Active Comparator | Scar reconstruction: serial excision |
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| B2 | Experimental | Scar reconstruction: primary closure, using skin stretching device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split skin graft | Procedure | After wound bed preparation the skin defect is covered with a skin transplant (split skin graft) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the surface area of the scar after 12 months | 3 and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness | 3 and 12 months after surgery |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E Middelkoop, Professor | VU MC | Principal Investigator |
| P.P.M. van Zuijlen, MD, PhD | Red Cross Hospital Beverwijk | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Red Cross Hospital | Beverwijk | Netherlands |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| skin stretching device | Procedure | after woundbed preparation the wound is primarily closed by aid of the skin stretching device |
|
| serial excision | Procedure | as much scar as possible is excised, whereafter the wound is closed |
|
| skin stretching device | Procedure | after the scar is excised, the wound is primarily closed by aid of the skin stretching device |
|