The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
Overview
- Phase
- Phase 4
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- the change of surface area of the scar
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
the change of surface area of the scar
Time Frame: change from surgery at 6 months
it is performed by tracing the area of the scar directly onto non-stretchable transparent sterile sheets. then digitized and analyzed by software.
Secondary Outcomes
- Operation time(during surgery)
- Vancouver scar scale (VSS)(3 and 6 months after surgery)
- scar vascularization index(3 and 6 months after surgery)
- Wound site and wound healing time(from surgery to 6 months)
- scar pigmentation index(3 and 6 months after surgery)
- dermal matrix arrangement under electron microscopy(surgery and 6 months after surgery)
- collagen fibers arrangement under electron microscopy(surgery and 6 months after surgery)