NCT03141502

The New Skin Stretching Device for Treatment of Limb Tension Wounds

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-11
• Primary completion: 2018-08-31
• Completion: 2018-10-31
• First posted: 2017-05-05
• Last updated: 2017-05-05

Locations

1 site across 1 country: China