The New Skin Stretching Device for Treatment of Limb Tension Wounds (SSDRCT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Wounds and Injuries; Trauma; Fractures, Open; Skin Expander
• Intervention / Treatment: Device: Skin stretching device (SSD); Procedure: Skin grafting

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Skin Stretching Device (SSD); the wound is primarily closed by aid of the SSD after necessary surgical debridement.	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.
ACTIVE_COMPARATOR: Skin Grafting (SG); the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.	Procedure: Skin grafting; the standard technique of skin grafting after wound preparation.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Dalian Medical University
• Investigators: Principal Investigator: Xin Tang, The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

General Publications

• 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.
• Verhaegen PDHM, van Trier AJM, Jongen SJM, Vlig M, Nieuwenhuis MK, Middelkoop E, van Zuijlen PPM. Efficacy of skin stretching for burn scar excision: a multicenter randomized controlled trial. Plast Reconstr Surg. 2011 May;127(5):1958-1966. doi: 10.1097/PRS.0b013e31820cf4be.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 11, 2017
• Primary Completion (ANTICIPATED): August 31, 2018
• Study Completion (ANTICIPATED): October 31, 2018

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: tension wound; skin stretching device; skin grafting
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Open
• Other Study ID Numbers: LCSY2017-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No