ScarNCT04389164
Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds
A study testing Tissue-engineered skin grafts of autologous scar dermal scaffolds in people with Scar, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Hypertrophic scar is an inevitable outcome of wound repair. It affects the appearance and some scar contracture often leads to joint dysfunction.Patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.Skin grafting is currently the gold standard for scar repair.However… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Scar
- What is being tested?
- Tissue-engineered skin grafts of autologous scar dermal scaffolds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient is diagnosed as hypertrophic scar and needs surgical repair; The scar size was 10cm2 to 200cm2, and the site was not limited; Patients with stable vital signs and tolerable operation indicated by routine examination; Patients in good mental state, can follow the doctor's advice, regular return; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past.
Who cannot join
- Those who did not meet the inclusion criteria were found after the selected subjects; The follow-up time after inclusion was less than 2 times, and the objective efficacy could not be evaluated (but the adverse reactions could be evaluated); Subjects who violate protocol requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jiayuan Zhu, PI, 86-20-87755766 ext. 8276, zhujiay@mail.sysu.edu.cn
Zhicheng Hu, doctor
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Tissue-engineered Skin Grafts With Autologous Scar Dermal Scaffolds for the Repair of Hypertrophic Scars
Hypertrophic scar is an inevitable outcome of wound repair. It affects the appearance and some scar contracture often leads to joint dysfunction.Patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.Skin grafting is currently the gold standard for scar repair.However, there are often insufficient skin sources, easy to scar recurrence, lack of skin accessory organs.The application of composite skin graft can reduce the recurrence rate of scar healing and relieve the deficiency of skin source.However, its survival rate is not high, and acellular allogeneic dermal scaffolds are expensive, heavy medical burden.Therefore, how to effectively repair the wound surface after surgical excision of scar is the main problem to be solved urgently.
Dermal loss is the main cause of unsatisfactory scar repair and recurrence.The previous clinical study of the research group found that the application of autologous epidermal basal cells and autologous skin graft obtained in real time during the operation could effectively improve the survival rate of skin graft in the treatment of wound surface (Brit J Surg, 2015).Furthermore, it is suggested that the application of autologous scar dermal scaffolds can achieve the control of skin damage in the skin harvesting area and the orthotopic transplantation of autologous scar tissue dermal scaffolds, which can effectively reduce the economic burden of patients.Therefore, the researchers wondered whether the construction of tissue-engineered skin orthotopic transplantation with autologous epidermal basal cells and autologous scar dermal scaffold combined with autologous scar dermal scaffolds to repair the wound after scar resection could improve the survival rate of skin graft and reduce scar recurrence.To this end, we plan to carry out multi-center, prospective, randomized, controlled clinical trials, aiming at proposing more effective surgical treatment guidelines for the repair of hypertrophic scar, improving the survival rate of composite skin graft, and solving the current clinical problems of hypertrophic scar repair.
- Conditions
- Scar
- Being tested
- Tissue-engineered skin grafts of autologous scar dermal scaffolds
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue-engineered skin grafts of autologous scar dermal scaffoldsProcedure or surgery
- scar excision. The thickness of scar tissue in the middle of scar is removed with a roller cutter and the thickness is about 0.01 -- 0.02mm.
- take autologous skin slices of the patient with an electric skin knife, cut out a small piece of skin, and prepare autologous epidermal basal cell suspension for use;The rest of the skin should be the same size as the wound.
- the prepared autogenous scar dermal stent was grafted onto the scar resection wound surface, and the prepared autoepidermal basal cells were sprayed between the mesh and on the dermal stent, and autologous skin slices were grafted onto the wound surface and fixed with pressure bandaging;
- after the operation, the outer dressing should be changed regularly according to the conventional treatment, and the wound surface condition should be observed and recorded according to the experimental scheme.
| Study group | Role | What they receive |
|---|---|---|
| Tissue engineering method | Experimental | The thickness of scar tissue in the middle of the dermis is removed by a roller cutter with a thickness of about 0.01 -- 0.02mm. After cleaning, the dermis can be used for punching and mesh drawing in the dermal rolling machine.Autologous epidermal basal cell suspension was prepared according to the description of autologous epidermal basal cell extraction box.The size of the remaining skin should be the same as the wound surface. After washing with normal saline, the wet yarn should be wrapped for later use.The autogenous scar dermal scaffold was prepared and transplanted onto the wound surface. The autoepidermal basal cells prepared were sprayed or coated between the mesh and the dermal scaffold. Autologous skin slices were transplanted onto the wound surface and fixed with pressure bandaging. Receives: Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds |
| Conventional therapy | Active comparator | Autologous skin was grafted onto the wound surface and fixed with pressure bandage Receives: Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffolds |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate
the percentage of subjects that achieved complete wound closure,complete wound closure is defined as skin conplete reepithelialization without drainage or dressing requirements.
Measured: postsurgery week 4
Secondary outcomes (1)
wound reducing rate
the rate of wound reducing based on week 4 after surgery
Measured: postsurgery week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Mar 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Jiayuan, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- ZHU JIAYUAN, Study director, Professor, chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389164
- Sponsor's protocol ID
- 2018002
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 15 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial of Tissue-engineered Skin Grafts With Autologous Scar Dermal Scaffolds for the Repair of Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT04389164
- Acronym / sponsor ID
- 2018002
- Conditions
- Scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 May 2020 (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.
Hypertrophic scar is an inevitable outcome of wound repair. It affects the appearance and some scar contracture often leads to joint dysfunction.Patients have low quality of life, long treatment cycle, heavy social burden and high medical costs.Skin grafting is currently the gold standard for scar repair.However, there are often insufficient skin sources, easy to scar recurrence, lack of skin accessory organs.The application of composite skin graft can reduce the recurrence rate of scar healing and relieve the deficiency of skin source.However, its survival rate is not high, and acellular allogeneic dermal scaffolds are expensive, heavy medical burden.Therefore, how to effectively repair the wound surface after surgical excision of scar is the main problem to be solved urgently.
Dermal loss is the main cause of unsatisfactory scar repair and recurrence.The previous clinical study of the research group found that the application of autologous epidermal basal cells and autologous skin graft obtained in real time during the operation could effectively improve the survival rate of skin graft in the treatment of wound surface (Brit J Surg, 2015).Furthermore, it is suggested that the application of autologous scar dermal scaffolds can achieve the control of skin damage in the skin harvesting area and the orthotopic transplantation of autologous scar tissue dermal scaffolds, which can effectively reduce the economic burden of patients.Therefore, the researchers wondered whether the construction of tissue-engineered skin orthotopic transplantation with autologous epidermal basal cells and autologous scar dermal scaffold combined with autologous scar dermal scaffolds to repair the wound after scar resection could improve the survival rate of skin graft and reduce scar recurrence.To this end, we plan to carry out multi-center, prospective, randomized, controlled clinical trials, aiming at proposing more effective surgical treatment guidelines for the repair of hypertrophic scar, improving the survival rate of composite skin graft, and solving the current clinical problems of hypertrophic scar repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue engineering method | Experimental | Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffoldsThe thickness of scar tissue in the middle of the dermis is removed by a roller cutter with a thickness of about 0.01 -- 0.02mm. After cleaning, the dermis can be used for punching and mesh drawing in the dermal rolling machine.Autologous epidermal basal cell suspension was prepared according to the description of autologous epidermal basal cell extraction box.The size of the remaining skin should be the same as the wound surface. After washing with normal saline, the wet yarn should be wrapped for later use.The autogenous scar dermal scaffold was prepared and transplanted onto the wound surface. The autoepidermal basal cells prepared were sprayed or coated between the mesh and the dermal scaffold. Autologous skin slices were transplanted onto the wound surface and fixed with pressure bandaging. |
| Conventional therapy | Active comparator | Procedure: Tissue-engineered skin grafts of autologous scar dermal scaffoldsAutologous skin was grafted onto the wound surface and fixed with pressure bandage |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patient is diagnosed as hypertrophic scar and needs surgical repair; The scar size was 10cm2 to 200cm2, and the site was not limited; Patients with stable vital signs and tolerable operation indicated by routine examination; Patients in good mental state, can follow the doctor's advice, regular return; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past; Those whom the researchers considered unsuitable for inclusion; Patients have participated in this study at any time in the past.
Key exclusion criteria (1 listed)
- Those who did not meet the inclusion criteria were found after the selected subjects; The follow-up time after inclusion was less than 2 times, and the objective efficacy could not be evaluated (but the adverse reactions could be evaluated); Subjects who violate protocol requirements.
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 |
|---|---|---|
| Tissue-engineered skin grafts of autologous scar dermal scaffolds1. scar excision. The thickness of scar tissue in the middle of scar is removed with a roller cutter and the thickness is about 0.01 -- 0.02mm. 2. take autologous skin slices of the patient with an electric skin knife, cut out a small piece of skin, and prepare autologous epidermal basal cell suspension for use;The rest of the skin should be the same size as the wound. 3. the prepared autogenous scar dermal stent was grafted onto the scar resection wound surface, and the prepared autoepidermal basal cells were sprayed between the mesh and on the dermal stent, and autologous skin slices were grafted onto the wound surface and fixed with pressure bandaging; 4. after the operation, the outer dressing should be changed regularly according to the conventional treatment, and the wound surface condition should be observed and recorded according to the experimental scheme. | Procedure or surgery | Conventional therapy, Tissue engineering method |
Primary outcome
healing rate
Time frame: postsurgery week 4
the percentage of subjects that achieved complete wound closure,complete wound closure is defined as skin conplete reepithelialization without drainage or dressing requirements.
1 secondary outcome
wound reducing rate
Time frame: postsurgery week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- 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.
ZHU JIAYUAN study director
Professor, chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue-engineered skin grafts of autologous scar dermal scaffolds in people with Scar, run by First Affiliated Hospital, Sun Yat-Sen 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 May 2020. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZHU JIAYUAN (86-20-87755766 ext. 8276, zhujiay@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing rate (time frame: postsurgery week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2020.