UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057090 |
|---|---|
| Receipt number | R000065255 |
| Scientific Title | Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2025/02/20 10:57:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds
Acronym
Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds
Scientific Title
Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds
Scientific Title:Acronym
Prospective, single-arm, observational study of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds
Region
| Japan |
Condition
Condition
The subject who was diagnosed as chronic wounds, refractory ulcer, postoperative wound breakdown or open wounds
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial will be conducted to confirm safety and efficacy of a novel biofilm-removing desiccant agent, Debrichem for Japanese patients with chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds for which treatment appears to have been delayed due to biofilm, based on the following objectives:
- Confirmation of Debrichem therapy technique in accordance with IFU for the purpose of rapid spreading in Japan after approval.
- Confirmation of alternative dressing technique using standard of care such as dressing products and anesthetic agents available in Japan
- Investigation of some combination therapies with currently available therapy for chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds in Japan, such as Surgical debridement, STSG and so on
- Confirmation of usefulness of CCsteps, medical device for checking existence of biofilm, on the effectiveness of biofilm removal after use of Debrichem
- Establishment of a useful and proper training program of Debrichem technique for Japanese clinicians
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Removal of biofilm and granulation tissue development at treatment site of wounds
Key secondary outcomes
Safety (Pain after treatment with Debrichem, Delayed Healing, Infection, devices malfunctioning etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Debrichem with standard of care such as surgical debridement, STSG or NPWT if needed for will be performed for chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds to evaluate removal of biofilm soon after treatment with Debrichem and one week after. And percentage of poor granulation tissue after one month. *In the case of proceeding next treatment step, 0% is applied as poor granulation tissue.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)The patient who consented to this treatment
(2)The subject who was diagnosed as chronic wounds, refractory ulcer, postoperative wound breakdown and open wounds
(3)Patients diagnosed by a physician as having delayed healing of the wound site
Key exclusion criteria
(1)The patient who did not consent to this treatment
(2)The patient whose biofilm could not be detected by the CC Steps biofilm detection device before using Debrichem
(3)Ischemic ulcers prior to an effective revascularization
(4)Neoplastic Ulcers
(5)Underlying abscesses or fasciitis which require lancing
(6)Underlying osteomyelitis
(7)Intolerance for any of the ingredients
(8)Allergies to any of the ingredients
(9)Patients in pregnant and patients who may be pregnant and patients in lactating
(10)Underlying cartilage
(11)Dry full thickness non-viable tissue (eschar), unless removed pre-debridement
(12)The patient judged by the investigator to be inappropriate as subjects of this study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Matsumura |
Organization
Kumagayageka hospital
Division name
Plastic surgery
Zip code
360-0023
Address
3811-1,Sayada,Kumagaya city, Saitama
TEL
048-521-4115
hmatsu-tki@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Matsumura |
Organization
Kumagayageka hospital
Division name
Plastic surgery
Zip code
360-0023
Address
3811-1,Sayada,Kumagaya city, Saitama
TEL
048-521-4115
Homepage URL
hmatsu-tki@umin.ac.jp
Sponsor or person
Institute
Kumagayageka Hospital
Institute
Department
Personal name
Funding Source
Organization
DEBx Medical B.V.
Saraya Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takuya Harada, Administrative department, Kumagayageka hospital
Address
3811-1,Sayada,Kumagaya city, Saitama
Tel
048-521-4115
kumage14@kumagayageka.or.jp
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
熊谷外科病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 25 | 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
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065255
