Healing WoundNCT06173908
Autologous Epidermal Cell Treat for Nonhealing Postoperative Wound
A study testing cell treatment in people with Healing Wound, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds. At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the… Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Healing Wound
- What is being tested?
- cell treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2024
- Phase
- Interventional
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1) the age of the subject on the day of signing the informed consent is 18 years old or above;
- the diagnosis was non-union of incision, and the diagnosis criteria of non-union of incision were as follows: non-union of incision > for 2 weeks after various surgeries;
- patients with stable vital signs, who are proved to be tolerable to surgery by routine examination;
- the patient is in good mental state, can follow the doctor's advice and return to the hospital regularly;
- understand and willing to participate in this clinical trial and provide the signed informed consent
Who cannot join
- (1) local wound complicated with malignant tumor;
- during the screening period, patients showed immunosuppression due to potential diseases, long-term immunosuppressive therapy or the use of large doses of glucocorticoid (i.e.
- patients with mental diseases;
- patients with serious uncontrolled diseases or acute systemic infections and other serious visceral diseases such as heart, lung and brain diseases;
- if the researcher considers the inclusion inappropriate;
- the patients were pregnant women, fertile women who did not take appropriate contraceptive measures, lactating women during the screening period or women who planned to become pregnant within 1 month after the end of the study;
- the patient participated in this study at any time in the past and the patient is participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiayuan Zhu
Guangzhou, Guangdong, 510080
Jiayuan Zhu, 13802751558, zhujiay@mail.sysu.edu.cn
About this study
Official title: Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds.
At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.
Read the detailed description
Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds, show the incision infection, effusion, hemorrhage, empyema, skin lesions and skin defect. It has a high morbidity and the treatment cycle is long, the social and economic burden is heavy.
At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Therefore, how to improve the wound healing rate is an urgent problem to be solved. The present study indicated that the disturbance of wound microenvironment was the main reason for the wound healing. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.
- Conditions
- Healing Wound
- Being tested
- cell treatment, control treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell treatmentProcedure or surgery
Autologous epidermal basal cells were used to repair nonhealing postoperative wound
control treatmentProcedure or surgery
anyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound
| Study group | Role | What they receive |
|---|---|---|
| cell treatment | Experimental | Autologous epidermal basal cells were used to treat postoperative nonhealing wounds Receives: Procedure: cell treatment |
| control treatment | Sham comparator | Conventional method were used to treat postoperative nonhealing wounds Receives: Procedure: control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing rate
wound healing rate
Measured: postoperative day 7, 14, 21, 28
Secondary outcomes (3)
healing time
wound healing time
Measured: when the wound was complete healed，through study completion, an average of 1 or 2 weeks
recurrence rate
recurrence rate
Measured: postoperative month 3
Wound reduction rate
Wound reduction rate
Measured: postoperative day 7, 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 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
- Jiayuan Zhu, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173908
- Sponsor's protocol ID
- SYSU-FAH-2019286
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 18 Dec 2023
- 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 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT06173908
- Acronym / sponsor ID
- SYSU-FAH-2019286
- Conditions
- Healing Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Dec 2023 (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.
Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds.
At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.
Detailed description
Postoperative incision healing (Postoperative incision non - ranging) occurred in the surgical incision more than 2 weeks after the operation is still not healing wounds, show the incision infection, effusion, hemorrhage, empyema, skin lesions and skin defect. It has a high morbidity and the treatment cycle is long, the social and economic burden is heavy.
At present, direct suture, autologous skin graft transplantation, conventional dressing change and negative pressure wound therapy are still the first-line treatment options for postoperative wound nonunion. However, the wound healing time is long and the wound healing rate is low. Therefore, how to improve the wound healing rate is an urgent problem to be solved. The present study indicated that the disturbance of wound microenvironment was the main reason for the wound healing. Autologous epidermal basal cell suspension is derived from the basal layer of the epidermis and contains 1-10% epidermal stem cells. Therefore, we plan to carry out a multi-center, prospective randomized controlled clinical trial, aiming to verify whether this technique can promote wound healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cell treatment | Experimental | Procedure: cell treatmentAutologous epidermal basal cells were used to treat postoperative nonhealing wounds |
| control treatment | Sham comparator | Procedure: control treatmentConventional method were used to treat postoperative nonhealing wounds |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- (1) the age of the subject on the day of signing the informed consent is 18 years old or above;
Key exclusion criteria (7 listed)
- (1) local wound complicated with malignant tumor;
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 |
|---|---|---|
| cell treatmentAutologous epidermal basal cells were used to repair nonhealing postoperative wound | Procedure or surgery | cell treatment |
| control treatmentanyother treatments except autologous epidermal basal cells were used to repair nonhealing postoperative wound | Procedure or surgery | control treatment |
Primary outcome
healing rate
Time frame: postoperative day 7, 14, 21, 28
wound healing rate
3 secondary outcomes
healing time
Time frame: when the wound was complete healed，through study completion, an average of 1 or 2 weeks
recurrence rate
Time frame: postoperative month 3
Wound reduction rate
Time frame: postoperative day 7, 14, 21, 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- 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.
Jiayuan Zhu principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cell treatment in people with Healing Wound, 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 5 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 18 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Zhu (13802751558, 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: postoperative day 7, 14, 21, 28). 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 18 Dec 2023.