The New Skin Stretching Device for Treatment of Limb Tension Wounds
NCT03141502 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-05-05
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.
Conditions
- Trauma
- Fractures, Open
- Wounds and Injuries
- Skin Expander
Interventions
- DEVICE
-
Skin stretching device (SSD)
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.
- PROCEDURE
-
Skin grafting
the standard technique of skin grafting after wound preparation.
Sponsors & Collaborators
-
The First Affiliated Hospital of Dalian Medical University
lead OTHER
Principal Investigators
-
Xin Tang · The First Affiliated Hospital of Dalian Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-11
- Primary Completion
- 2018-08-31
- Completion
- 2018-10-31
Countries
- China
Study Locations
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