The New Skin Stretching Device for Treatment of Limb Tension Wounds

Study Overview
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Brief Summary
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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
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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.

Official Title
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The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study

Conditions
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Trauma, Fractures, Open, Wounds and Injuries, Skin Expander

Intervention / Treatment
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* Device: Skin stretching device (SSD)
* Procedure: Skin grafting


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age≥18 years old Tension incision that cannot be directly closed due to limb trauma or surgical debridement Incision that cannot be directly closed after the incision decompression for fascia compartment syndrome and ischemia and reperfusion injury Both sides of the incision skin suitable for skin stretching Exclusion criteria: Age <18 years old Skin disease Keloid history Local or systemic use of hormones Systemic diseases: for example, diabetes, immunodeficiency disease, vascular disease and etc. Other poor general state to result in inability for trial; Mental illness.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin Stretching Device (SSD)<br>the wound is primarily closed by aid of the SSD after necessary surgical debridement. | Device: Skin stretching device (SSD)<br>* 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.<br>|
| Active Comparator: Skin Grafting (SG)<br>the wound is primarily closed by the technique of skin grafting after necessary surgical debridement. | Procedure: Skin grafting<br>* the standard technique of skin grafting after wound preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from surgery at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | refers to the time required for the application of skin stretching device or skin grafting | 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. | from surgery to 6 months | 
| Vancouver scar scale (VSS) | evaluate the scar scale by VSS | 3 and 6 months after surgery | 
| scar vascularization index | use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization | 3 and 6 months after surgery | 
| scar pigmentation index | use photometric analyzer to measure its melanin index, assessing its pigmentation | 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 | 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 | surgery and 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tension wound, skin stretching device, skin grafting