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

The First Affiliated Hospital of Dalian Medical University

Status and phase: Unknown; Phase 4

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

Treatments: Procedure: Skin grafting; Device: Skin stretching device (SSD)

Study type: Interventional

Funder types: Other

Identifiers

NCT03141502

LCSY2017-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Skin Stretching Device (SSD)

Experimental group

Description:

the wound is primarily closed by aid of the SSD after necessary surgical debridement.

Treatment:

Device: Skin stretching device (SSD)

Skin Grafting (SG)

Active Comparator group

Description:

the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.

Treatment:

Procedure: Skin grafting