TraumaPhase 4SSDRCTNCT03141502
The New Skin Stretching Device for Treatment of Limb Tension Wounds
A Phase 4 study testing Skin stretching device (SSD) and Skin grafting in people with Trauma and Fractures, Open, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Fractures, Open, Wounds and Injuries
- What is being tested?
- Skin stretching device (SSD) and Skin grafting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2017to 31 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Nuo Li, 86-0411-83635963 ext. 3015, dyyykyb@163.com
Yinan Wang, 86-0411-83635963 ext. 3037, dyfyjwb@163.com
About this study
Official title: The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
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.
Read the 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
- Being tested
- Skin stretching device (SSD), Skin grafting
- Keywords
- tension wound, skin stretching device, skin grafting
- Medical subject headings
- Wounds and Injuries, Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 graftingProcedure or surgery
the standard technique of skin grafting after wound preparation.
| Study group | Role | What they receive |
|---|---|---|
| Skin Stretching Device (SSD) | Experimental | the wound is primarily closed by aid of the SSD after necessary surgical debridement. Receives: 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. Receives: Procedure: Skin grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from surgery at 6 months
Secondary outcomes (7)
Operation time
refers to the time required for the application of skin stretching device or skin grafting
Measured: during surgery
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.
Measured: from surgery to 6 months
Vancouver scar scale (VSS)
evaluate the scar scale by VSS
Measured: 3 and 6 months after surgery
scar vascularization index
use photometric analyzer to measure its erythema index, assessing its angiogenesis and vascularization
Measured: 3 and 6 months after surgery
scar pigmentation index
use photometric analyzer to measure its melanin index, assessing its pigmentation
Measured: 3 and 6 months after surgery
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
Measured: surgery and 6 months after surgery
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
Measured: surgery and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start11 May 2017 (estimated)
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Tang, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141502
- Sponsor's protocol ID
- LCSY2017-05
- Acronym
- SSDRCT
- Status last verified
- Apr 2017
- First submitted
- 26 Apr 2017
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24746282Verhaegen 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.
PubMed 21228739
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT03141502
- Acronym / sponsor ID
- SSDRCT / LCSY2017-05
- Conditions
- Trauma, Fractures, Open, Wounds and Injuries, Skin Expander
- Keywords
- tension wound, skin stretching device, skin grafting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 11 May 2017 (estimated)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Stretching Device (SSD) | Experimental | Device: Skin stretching device (SSD)the wound is primarily closed by aid of the SSD after necessary surgical debridement. |
| Skin Grafting (SG) | Active comparator | Procedure: Skin graftingthe wound is primarily closed by the technique of skin grafting after necessary surgical debridement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Skin Stretching Device (SSD) |
| Skin graftingthe standard technique of skin grafting after wound preparation. | Procedure or surgery | Skin Grafting (SG) |
Primary outcome
the change of surface area of the scar
Time frame: change from surgery at 6 months
it is performed by tracing the area of the scar directly onto non-stretchable transparent sterile sheets. then digitized and analyzed by software.
7 secondary outcomes
Operation time
Time frame: during surgery
Wound site and wound healing time
Time frame: from surgery to 6 months
Vancouver scar scale (VSS)
Time frame: 3 and 6 months after surgery
scar vascularization index
Time frame: 3 and 6 months after surgery
scar pigmentation index
Time frame: 3 and 6 months after surgery
collagen fibers arrangement under electron microscopy
Time frame: surgery and 6 months after surgery
dermal matrix arrangement under electron microscopy
Time frame: surgery and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 24746282Verhaegen 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.
- Background: PubMed 21228739Verhaegen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Tang principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Skin stretching device (SSD) and Skin grafting in people with Trauma and Fractures, Open, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junwei Zong, MD (86041183635963 ext. 3131, aweizone@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of surface area of the scar (time frame: change from surgery at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03141502, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.