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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03141502
Other study ID # LCSY2017-05
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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