A Phase 4 interventional study of Skin stretching device (SSD) and Skin grafting in Trauma, Fractures, Open and Wounds and Injuries, sponsored by The First Affiliated Hospital of Dalian Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-05.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Phase 4, Interventional, and Treatment
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:
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.
Exclusion criteria:
the wound is primarily closed by aid of the SSD after necessary surgical debridement.
Device: Skin stretching device (SSD)
the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.
Procedure: Skin grafting
By making use of skin viscoelasticity, the special metal crochet of SSD would be embedded in both sides skin of the wound. Multiple cycles of stretching and relaxing wound lead to extended skin, changing the high tension incision into a low tension incision and facilitating the direct suture.
the standard technique of skin grafting after wound preparation.
the change of surface area of the scar
it is performed by tracing the area of the scar directly onto non-stretchable transparent sterile sheets. then digitized and analyzed by software.
Time frame: change from surgery at 6 months
Operation time
refers to the time required for the application of skin stretching device or skin grafting
Time frame: during surgery
Wound site and wound healing time
record the site of the operation, and the time from the beginning of surgery to the complete healing of the wound.
Time frame: from surgery to 6 months
Vancouver scar scale (VSS)
evaluate the scar scale by VSS
Time frame: 3 and 6 months after surgery
scar vascularization index
use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization
Time frame: 3 and 6 months after surgery
scar pigmentation index
use photometric analyzer to measure its melanin index, assessing its pigmentation
Time frame: 3 and 6 months after surgery
collagen fibers arrangement under electron microscopy
use the drilling device to take the skin tissue of the diameter of 3mm for histological examination, measuring the collagen fibers arrangement by Electron microscopy
Time frame: surgery and 6 months after surgery
dermal matrix arrangement under electron microscopy
use the drilling device to take the skin tissue of the diameter of 3mm for histological examination, measuring the dermal matrix arrangement by Electron microscopy
Time frame: surgery and 6 months after surgery
Plan to share: No
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The First Affiliated Hospital of Dalian Medical University