NCT03141502

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

May 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 26, 2017

Last Update Submit

May 4, 2017

Conditions

TraumaFractures, OpenWounds and InjuriesSkin Expander

Keywords

tension woundskin stretching deviceskin grafting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Operation time

    during surgery

  • Wound site and wound healing time

    from surgery to 6 months

  • Vancouver scar scale (VSS)

    3 and 6 months after surgery

  • scar vascularization index

    3 and 6 months after surgery

  • scar pigmentation index

    3 and 6 months after surgery

  • +2 more secondary outcomes

Study Arms (2)

Skin Stretching Device (SSD)

EXPERIMENTAL

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

Device: Skin stretching device (SSD)

Skin Grafting (SG)

ACTIVE COMPARATOR

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

Procedure: Skin grafting

Interventions

Skin stretching device (SSD)DEVICE

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.

Skin Stretching Device (SSD)
Skin graftingPROCEDURE

the standard technique of skin grafting after wound preparation.

Skin Grafting (SG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age≥18 years old
  • Tension incision that cannot be directly closed due to limb trauma or surgical debridement
  • Incision that cannot be directly closed after the incision decompression for fascia compartment syndrome and ischemia and reperfusion injury
  • Both sides of the incision skin suitable for skin stretching

You may not qualify if:

  • Age \<18 years old
  • Skin disease
  • Keloid history
  • Local or systemic use of hormones
  • Systemic diseases: for example, diabetes, immunodeficiency disease, vascular disease and etc.
  • Other poor general state to result in inability for trial;
  • Mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Related 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.

    PMID: 24746282BACKGROUND

  • 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.

    PMID: 21228739BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesFractures, Open

Interventions

Skin Transplantation

Condition Hierarchy (Ancestors)

Fractures, Bone

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDermatologic Surgical ProceduresPlastic Surgery ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Xin Tang

    The First Affiliated Hospital of Dalian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Zong, MD

CONTACT

86041183635963aweizone@163.com

Nuo Li

CONTACT

86041183635963dyyykyb@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 5, 2017

Study Start

May 11, 2017

Primary Completion

August 31, 2018

Study Completion

October 31, 2018

Last Updated

May 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)