UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056733 |
|---|---|
| Receipt number | R000064523 |
| Scientific Title | Efficacy and Safety of Epidermal Cell Regeneration for Postoperative Non-Healing Wounds: A Randomized, Partially Blinded, Parallel-Controlled Trial |
| Date of disclosure of the study information | 2025/01/17 |
| Last modified on | 2025/01/21 02:09:03 |
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Basic information
Public title
Clinical study of the Therapeutic Effects of autologous epidermal cell regeneration technique on Postoperative Incision Non-healing Wound
Acronym
CSOTEOAECRTOPINW
Scientific Title
Efficacy and Safety of Epidermal Cell Regeneration for Postoperative Non-Healing Wounds: A Randomized, Partially Blinded, Parallel-Controlled Trial
Scientific Title:Acronym
CS
Region
| Asia(except Japan) |
Condition
Condition
Inclusion criteria: (1) Age: adults aged 18 years or older with complete clinical data. + (2) The incision still does not heal beyond the normal healing time (2-4 weeks) after various surgeries; (2) Surgery during treatment. Exclusion criteria: (1) local malignant tumor on the wound; (2) Those who are not suitable for surgery or are intolerant to surgery.
Classification by specialty
| Medicine in general | Surgery in general | Gastrointestinal surgery |
| Chest surgery | Breast surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, a new treatment method (autologous epidermal cell regeneration technology) was used to repair postoperative incision non-healing wound.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healing rate 3 weeks after surgery
Key secondary outcomes
wound closure time and the recurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment Group Autologous epidermal cell regeneration technology
Interventions/Control_2
Experimental group include standard wound management treatments including wound bed preparation, suturing, skin grafting, flap repair, or conservative management
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 18 to 80 years who had surgical wounds that failed to heal after the normal healing time (2-4 weeks), defined as non-healing after conventional treatment. Only patients who did not respond to at least one aspect of standard treatment were included.
Key exclusion criteria
Patients with exposed bone, osteomyelitis, systemic infection, or severe local infection. Ulcers caused by malignant tumors invading the skin. Patients with untreated vascular ulcers. Severe malnutrition due to various causes (serum albumin < 3.0 g/dL). Serious comorbidities, such as diabetic foot with absent pulses in the dorsalis pedis or posterior tibial arteries, deep vein thrombosis, allergic diseases, or any other acute phase of an immune system disorder.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Xiaohui |
| Middle name | |
| Last name | Li |
Organization
The First Affiliated Hospital of Sun Yat-sen University
Division name
Department of Burn and Wound Repair Surgery
Zip code
510080
Address
58 Zhongshan Second Road, Guangzhou
TEL
+86-20-87755766-8235
zhujiay@mail.sysu.edu.cn
Public contact
Name of contact person
| 1st name | Jiayuan |
| Middle name | |
| Last name | zhu |
Organization
The First Affiliated Hospital of Sun Yat-sen University
Division name
Department of Burn and Wound Repair Surgery
Zip code
510080
Address
58 Zhongshan Second Road, Guangzhou
TEL
+86-20-87755766-8235
Homepage URL
zhujiay@mail.sysu.edu.cn
Sponsor or person
Institute
Department of Burn and Wound Repair Surgery
The First Affiliated Hospital of Sun Yat-sen University
Institute
Department
Personal name
Funding Source
Organization
National Natural Science Foundation of China (30973128, 81272096)
Sun Yat-sen University Clinical Research 5010 Program (2013001)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The First Affiliated Hospital of Sun Yat-sen University
Address
58 Zhongshan Second Road, Guangzhou
Tel
+86-20-87755766-8235
zhujiay@mail.sysu.edu.cn
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The primary endpoint was the healing rate at 3 weeks. Two key secondary endpoints were wound closure time and the recurrence rate within six months. Additional secondary endpoints included surgical time, total number of surgeries, and length of hospital stay. Complete wound healing was defined as full closure of the wound, including no exudation or cracking after suture removal.
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics included gender, age, duration of non-healing, wound size, wound location, and underlying diseases.
Participant flow
Preoperative visits were conducted at least one week prior to randomization, followed by reassessment, which included anesthesia and preoperative examinations. These procedures were performed to ensure baseline homogeneity among the study population. Patients were randomly allocated (1:1) to either the experimental group or the control group using a centrally generated computer randomization list. All patients underwent standard "wound bed preparation" treatments before surgery, including regular wound dressing changes, standard preoperative preparations, antimicrobial therapy, and general medical treatment. After the wound was adequately prepared, the surgeon assessed the wound and selected the appropriate surgical procedure based on randomization.
Adverse events
The safety analysis was conducted in the safety population with a follow-up duration of 26 weeks. Adverse events include general adverse events such as wound swelling, wound exudation or pus discharge, wound dehiscence, skin graft failure, keloid or scar contracture.Serious adverse events include persistent non-healing wounds, sepsis, multiple organ failure, etc. Treatment-related ones include carcinogenic ,immune rejection and hospital stays longer than 30 days.
Outcome measures
The primary endpoint was the wound healing rate at week 3.Two key secondary endpoints were wound closure time and the recurrence rate within six months.
Plan to share IPD
IPD data will be shared in anonymized format to ensure participant privacy. The data will be made available within 6 months after the study completion. Researchers can access the data by request and after signing a data-sharing agreement
IPD sharing Plan description
Data Type: The shared data will include anonymized participant demographics, clinical measurements, treatment outcomes, and adverse events data.
Privacy and Anonymization: All data will be anonymized and de-identified to protect participant confidentiality, in compliance with relevant privacy regulations (e.g., GDPR).
Sharing Conditions: Data will be shared with academic researchers for secondary analysis. A data-sharing agreement will be required for access.
Ethics Approval: The IPD sharing plan has been approved by the IRB, and all data sharing complies with ethical guidelines and regulatory standards.
Data Access: Data will be made accessible through the UMIN platform and/or other recognized academic repositories, with restricted access to authorized researchers only.
Update and Revision: Any updates to the shared data will be posted promptly on the data-sharing platform.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064523
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/01/16 | Research Plan.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/01/17 | Research case data specifications.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/01/17 | Research Case Data.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/64523
