The New Skin Stretching Device for Treatment of Limb Tension Wounds

Phase 4

• Conditions: Trauma; Skin Expander; Fractures, Open; Wounds and Injuries
• Interventions: Device: Skin stretching device (SSD); Procedure: Skin grafting

• Registration Number: NCT03141502
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

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 Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-04
• Last Update Submitted: 2017-05-04
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05
• Study Start: 2017-05-11
• Primary Completion: 2018-08-31
• Study Completion: 2018-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin Stretching Device (SSD)	Skin stretching device (SSD)	the wound is primarily closed by aid of the SSD after necessary surgical debridement.
Skin Grafting (SG)	Skin grafting	the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.

Primary Outcome Measures

Name	Time	Method
the change of surface area of the scar	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 Outcome Measures

Name	Time	Method
Operation time	during surgery	refers to the time required for the application of skin stretching device or skin grafting
Vancouver scar scale (VSS)	3 and 6 months after surgery	evaluate the scar scale by VSS
scar vascularization index	3 and 6 months after surgery	use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization
Wound site and wound healing time	from surgery to 6 months	record the site of the operation, and the time from the beginning of surgery to the complete healing of the wound.
scar pigmentation index	3 and 6 months after surgery	use photometric analyzer to measure its melanin index, assessing its pigmentation
dermal matrix arrangement under electron microscopy	surgery and 6 months after surgery	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
collagen fibers arrangement under electron microscopy	surgery and 6 months after surgery	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

Trial Locations

Locations (1)

the First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China