Trauma Clinical Trial
Official title:
The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
A randomized controlled trial is performed to evaluate the effectiveness and safety of the Skin Stretching Device (SSD) on limb tension incision closure by comparing whether the differences in wounds area, wounds closure time and scar assessment between the SSD and the skin grafting are statistically significant.
Design:
This study is a multicenter and randomized control study with the participation of 15 major
national or regional central hospitals. And the whole sample size is set to be 100 patients.
Patients who have been screened by inclusion and exclusion criteria will be randomly
(non-transparent envelope) assigned to Skin Stretching Group (SS Group) or Skin Grafting
Group (SG Group). Patients of both group will undergo surgical debridement for the same
principle, while the Skin Stretching Device is used for the patients of SS Group for
incision closure and the Skin Grafting is used for the patients of SG group for incision
closure.
Outcome evaluation:
Wound and scar evaluation during surgery, three and six months after surgery will include
the following parameters:
- surface area;
- Vancouver scar scale (VSS)
- vascularization and pigmentation;
- dermal architecture. After 3 and 6 months patients will undergo a biopsy of the scar
under local anesthesia. The experimental group, treated with the SSD will undergo one
extra biopsy of the formerly stretched skin.
Safety evaluation:
During the trial, adverse events are observed and evaluated. Adverse reactions to clinical
manifestations are followed and recorded till the symptoms disappear. The subject with
serious adverse events shall withdraw from the study and be treated accordingly.
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