Clinical trial NCT03141502: The New Skin Stretching Device for Treatment of Limb Tension Wounds
Official title: The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Trauma
Fractures, Open
Wounds and Injuries
Skin Expander
Keywords: tension wound
skin stretching device
skin grafting
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the change of surface area of the scar
timeFrame: change from surgery at 6 months
Secondary outcomes:
measure: Operation time
timeFrame: during surgery
measure: Wound site and wound healing time
timeFrame: from surgery to 6 months
measure: Vancouver scar scale (VSS)
timeFrame: 3 and 6 months after surgery
measure: scar vascularization index
timeFrame: 3 and 6 months after surgery
measure: scar pigmentation index
timeFrame: 3 and 6 months after surgery
measure: collagen fibers arrangement under electron microscopy
timeFrame: surgery and 6 months after surgery
measure: dermal matrix arrangement under electron microscopy
timeFrame: surgery and 6 months after surgery
Other outcomes:
Locations:
city: Dalian
country: China
facility: the First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Xin Tang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.