The New Skin Stretching Device for Treatment of Limb Tension Wounds (SSDRCT)
Primary Purpose
Trauma, Fractures, Open, Wounds and Injuries
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Skin stretching device (SSD)
Skin grafting
Sponsored by
![The First Affiliated Hospital of Dalian Medical University](https://trials-media.s3.amazonaws.com/orgs/the-first-affiliated-hospital-of-dalian-medical-university.jpeg)
About this trial
This is an interventional treatment trial for Trauma focused on measuring tension wound, skin stretching device, skin grafting
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
Sites / Locations
- the First Affiliated Hospital of Dalian Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Skin Stretching Device (SSD)
Skin Grafting (SG)
Arm Description
the wound is primarily closed by aid of the SSD after necessary surgical debridement.
the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Operation time
refers to the time required for the application of skin stretching device or skin grafting
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.
Vancouver scar scale (VSS)
evaluate the scar scale by VSS
scar vascularization index
use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization
scar pigmentation index
use photometric analyzer to measure its melanin index, assessing its pigmentation
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
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
Full Information
NCT ID
NCT03141502
First Posted
April 26, 2017
Last Updated
May 4, 2017
Sponsor
The First Affiliated Hospital of Dalian Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03141502
Brief Title
The New Skin Stretching Device for Treatment of Limb Tension Wounds
Acronym
SSDRCT
Official Title
The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2017 (Anticipated)
Primary Completion Date
August 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Fractures, Open, Wounds and Injuries, Skin Expander
Keywords
tension wound, skin stretching device, skin grafting
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skin Stretching Device (SSD)
Arm Type
Experimental
Arm Description
the wound is primarily closed by aid of the SSD after necessary surgical debridement.
Arm Title
Skin Grafting (SG)
Arm Type
Active Comparator
Arm Description
the wound is primarily closed by the technique of skin grafting after necessary surgical debridement.
Intervention Type
Device
Intervention Name(s)
Skin stretching device (SSD)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin grafting
Intervention Description
the standard technique of skin grafting after wound preparation.
Primary Outcome Measure Information:
Title
the change of surface area of the scar
Description
it is performed by tracing the area of the scar directly onto non-stretchable transparent sterile sheets. then digitized and analyzed by software.
Time Frame
change from surgery at 6 months
Secondary Outcome Measure Information:
Title
Operation time
Description
refers to the time required for the application of skin stretching device or skin grafting
Time Frame
during surgery
Title
Wound site and wound healing time
Description
record the site of the operation, and the time from the beginning of surgery to the complete healing of the wound.
Time Frame
from surgery to 6 months
Title
Vancouver scar scale (VSS)
Description
evaluate the scar scale by VSS
Time Frame
3 and 6 months after surgery
Title
scar vascularization index
Description
use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization
Time Frame
3 and 6 months after surgery
Title
scar pigmentation index
Description
use photometric analyzer to measure its melanin index, assessing its pigmentation
Time Frame
3 and 6 months after surgery
Title
collagen fibers arrangement under electron microscopy
Description
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
Time Frame
surgery and 6 months after surgery
Title
dermal matrix arrangement under electron microscopy
Description
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
Time Frame
surgery and 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junwei Zong, MD
Phone
86041183635963
Ext
3131
Email
aweizone@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nuo Li
Phone
86041183635963
Ext
3015
Email
dyyykyb@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Tang
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuo Li
Phone
86-0411-83635963
Ext
3015
Email
dyyykyb@163.com
First Name & Middle Initial & Last Name & Degree
Yinan Wang
Phone
86-0411-83635963
Ext
3037
Email
dyfyjwb@163.com
First Name & Middle Initial & Last Name & Degree
Ming Lu, MD
First Name & Middle Initial & Last Name & Degree
Deqiang Zhang, MD
First Name & Middle Initial & Last Name & Degree
Chongyang Fu, MD
First Name & Middle Initial & Last Name & Degree
Junwei Junwei, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24746282
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.
Results Reference
background
PubMed Identifier
21228739
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.
Results Reference
background
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The New Skin Stretching Device for Treatment of Limb Tension Wounds
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