UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語

英語
Clinical study of the Therapeutic Effects of autologous epidermal cell regeneration technique on Postoperative Incision Non-healing Wound

一般向け試験名略称/Acronym

日本語

英語
CSOTEOAECRTOPINW

科学的試験名/Scientific Title

日本語

英語
Efficacy and Safety of Epidermal Cell Regeneration for Postoperative Non-Healing Wounds: A Randomized, Partially Blinded, Parallel-Controlled Trial

科学的試験名略称/Scientific Title:Acronym

日本語

英語
CS

試験実施地域/Region

アジア（日本以外）/Asia(except Japan)

対象疾患名/Condition

日本語

英語
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.

疾患区分1/Classification by specialty

内科学一般/Medicine in general	外科学一般/Surgery in general
消化器外科(消化管）/Gastrointestinal surgery	呼吸器外科学/Chest surgery
乳腺外科学/Breast surgery	成人/Adult

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語

英語
In this study, a new treatment method (autologous epidermal cell regeneration technology) was used to repair postoperative incision non-healing wound.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語

英語
Healing rate 3 weeks after surgery

副次アウトカム評価項目/Key secondary outcomes

日本語

英語
wound closure time and the recurrence rate

試験の種類/Study type

介入/Interventional

基本デザイン/Basic design

並行群間比較/Parallel

ランダム化/Randomization

ランダム化/Randomized

ランダム化の単位/Randomization unit

個別/Individual

ブラインド化/Blinding

介入実施者・測定者がブラインド化されている単盲検/Single blind -investigator(s) and assessor(s) are blinded

コントロール/Control

実薬・標準治療対照/Active

層別化/Stratification

いいえ/NO

動的割付/Dynamic allocation

いいえ/NO

試験実施施設の考慮/Institution consideration

施設を考慮していない/Institution is not considered as adjustment factor.

ブロック化/Blocking

いいえ/NO

割付コードを知る方法/Concealment

中央登録/Central registration

群数/No. of arms

2

介入の目的/Purpose of intervention

治療・ケア/Treatment

介入の種類/Type of intervention

医療器具・機器/Device,equipment

介入1/Interventions/Control_1

日本語

英語
Treatment Group Autologous epidermal cell regeneration technology

介入2/Interventions/Control_2

日本語

英語
Experimental group include standard wound management treatments including wound bed preparation, suturing, skin grafting, flap repair, or conservative management

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

18

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

80

歳/years-old

以下/>=

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語

英語
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.

除外基準/Key exclusion criteria

日本語

英語
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.

目標参加者数/Target sample size

170

責任研究者/Name of lead principal investigator

日本語

名
ミドルネーム
姓

英語

名	Xiaohui
ミドルネーム
姓	Li

所属組織/Organization

日本語

英語
The First Affiliated Hospital of Sun Yat-sen University

所属部署/Division name

日本語

英語
Department of Burn and Wound Repair Surgery

郵便番号/Zip code

510080

住所/Address

日本語

英語
58 Zhongshan Second Road, Guangzhou

電話/TEL

+86-20-87755766-8235

Email/Email

zhujiay@mail.sysu.edu.cn

試験問い合わせ窓口担当者/Name of contact person

日本語

名
ミドルネーム
姓

英語

名	Jiayuan
ミドルネーム
姓	zhu

組織名/Organization

日本語

英語
The First Affiliated Hospital of Sun Yat-sen University

部署名/Division name

日本語

英語
Department of Burn and Wound Repair Surgery

郵便番号/Zip code

510080

住所/Address

日本語

英語
58 Zhongshan Second Road, Guangzhou

電話/TEL

+86-20-87755766-8235

試験のホームページURL/Homepage URL

Email/Email

zhujiay@mail.sysu.edu.cn

機関名/Institute

日本語
その他

英語
Department of Burn and Wound Repair Surgery
The First Affiliated Hospital of Sun Yat-sen University

機関名/Institute
（機関選択不可の場合）

日本語

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
National Natural Science Foundation of China (30973128, 81272096)
Sun Yat-sen University Clinical Research 5010 Program (2013001)

機関名/Organization
（機関選択不可の場合）

日本語

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語

英語
The First Affiliated Hospital of Sun Yat-sen University

住所/Address

日本語

英語
58 Zhongshan Second Road, Guangzhou

電話/Tel

+86-20-87755766-8235

Email/Email

zhujiay@mail.sysu.edu.cn

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2025

年

01

月

17

日

プロトコル掲載URL/URL releasing protocol

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語

英語
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.

主な結果入力日/Results date posted

2025

年

01

月

16

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語

英語
Baseline characteristics included gender, age, duration of non-healing, wound size, wound location, and underlying diseases.

参加者の流れ/Participant flow

日本語

英語
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.

有害事象/Adverse events

日本語

英語
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.

評価項目/Outcome measures

日本語

英語
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.

個別症例データ共有計画/Plan to share IPD

日本語

英語
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

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語
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.

試験進捗状況/Recruitment status

限定募集中/Enrolling by invitation

プロトコル確定日/Date of protocol fixation

2019

年

01

月

01

日

倫理委員会による承認日/Date of IRB

2019

年

08

月

05

日

登録・組入れ開始（予定）日/Anticipated trial start date

2019

年

09

月

01

日

フォロー終了(予定)日/Last follow-up date

2024

年

12

月

30

日

入力終了(予定)日/Date of closure to data entry

2024

年

12

月

31

日

データ固定（予定）日/Date trial data considered complete

2025

年

01

月

10

日

解析終了(予定)日/Date analysis concluded

2025

年

01

月

14

日

その他関連情報/Other related information

日本語

英語

登録日時/Registered date

2025

年

01

月

16

日

最終更新日/Last modified on

2025

年

01

月

21

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000064523

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064523

単一の症例データURL/Single case data URL

日本語
https://center6.umin.ac.jp/ic/64523

英語
https://center6.umin.ac.jp/ice/64523