The New Skin Stretching Device for Treatment of Limb Tension Wounds

Trauma Clinical Trial

— SSDRCT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03141502
• Other study ID #: LCSY2017-05
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 26, 2017
• Last updated: May 4, 2017
• Start date: May 11, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: April 2017
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Junwei Zong, MD
• Phone: 86041183635963
• Email: aweizone[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Age=18 years old

2. Tension incision that cannot be directly closed due to limb trauma or surgical debridement

3. Incision that cannot be directly closed after the incision decompression for fascia compartment syndrome and ischemia and reperfusion injury

4. Both sides of the incision skin suitable for skin stretching

Exclusion criteria:

1. Age <18 years old

2. Skin disease

3. Keloid history

4. Local or systemic use of hormones

5. Systemic diseases: for example, diabetes, immunodeficiency disease, vascular disease and etc.

6. Other poor general state to result in inability for trial;

7. Mental illness.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Verhaegen PD, Bloemen MC, van der Wal MB, Vloemans AF, Tempelman FR, Beerthuizen GI, van Zuijlen PP. Skin stretching for primary closure of acute burn wounds. Burns. 2014 Dec;40(8):1727-37. doi: 10.1016/j.burns.2014.03.014. Epub 2014 Apr 16. — View Citation

Verhaegen PD, van Trier AJ, Jongen SJ, Vlig M, Nieuwenhuis MK, Middelkoop E, van Zuijlen PP. Efficacy of skin stretching for burn scar excision: a multicenter randomized controlled trial. Plast Reconstr Surg. 2011 May;127(5):1958-66. doi: 10.1097/PRS.0b013e31820cf4be. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operation time	refers to the time required for the application of skin stretching device or skin grafting	during surgery
Secondary	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
Secondary	Vancouver scar scale (VSS)	evaluate the scar scale by VSS	3 and 6 months after surgery
Secondary	scar vascularization index	use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization	3 and 6 months after surgery
Secondary	scar pigmentation index	use photometric analyzer to measure its melanin index, assessing its pigmentation	3 and 6 months after surgery
Secondary	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
Secondary	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