Chronic WoundNCT04019639
Efficacy of Paste Type Acellular Dermal Matrix(CG Paste) in Chronic Wound Healing
A study testing application of CG Paste+EasyFoam and application of EasyFoam in people with Chronic Wound, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of wound sizing and completeness in chronic window treatment, and to confirm the superiority of area reduction in CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and form-dressing companion groups. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Wound
- What is being tested?
- application of CG Paste+EasyFoam and application of EasyFoam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2017to 31 Jul 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over 19 years
- Patients with skin defect from full-thickness skin defect to bone exposure level after debridement of wound
- Chronic wounds that have not been healed despite adequate treatment for more than 3 weeks after wounding
- At the time of the study, patients with a wound size of 4 cm 2 or more
Who cannot join
- Patients with superficial or partial thickness skin defect
- osteomyelitis patient
- An undermining wound, tunneling wound, which can not measure the exact depth, can be used if the wound is open wound due to debridement of wound.
- Patients who exceeded 12% of HbA1c within 3 months before participating in the study
- Patients with serum creatinine concentration of 3.0 mg / dL or more within 30 days before the study
- Patients who have applied other medical devices and growth factors for wound healing within 30 days before participating in the study
- Patients with lesion infections (available after infection treatment)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Sang Wha Kim, Ph.D, 82-2-2072-2374, sw1215@snu.ac.kr
About this study
Official title: Clinical Trial for the Efficacy and Safety of Paste Type Acellular Dermal Matrix in Chronic Wound Healing
The purpose of this study is to evaluate the efficacy and safety of wound sizing and completeness in chronic window treatment, and to confirm the superiority of area reduction in CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and form-dressing companion groups.
Read the detailed description
wound refers to a condition in which the skin is damaged by a cause. In general, open wound rather than closed wound requires active treatment. It is important to make sure that the wound are cured early and through proper treatment. If the wound is open for a long time, secondary complications such as infection can occur and are easy to transition to chronic wound. Chronic wound refers to an idea that does not heal after a period of time after a normal wound healing process, which is usually defined as if it does not heal for more than three to four weeks. 1. These chronic wound include diabetic foot ulcer, pressure ulcer, vascular ulcer, etc. In addition, with the recent aging of the population, the proportion of elderly patients increases, and the proportion of chronic wound where even simple surgical wound does not heal normally, resulting in increased expenditure on health care and decreased quality of life for patients.
Biotechnical dermal transplantation material, including acellular dermal matrix, are known to be more effective in wound healing than conventional wound treatments.
The mechanism of action of acellular matrices including acellular dermal matrix, is as follows: 1) it functions as a support for cell growth and granulation tissue formation, 2) has receptors capable of attaching to fibroblasts, 3) induction of angiogenesis, 4) chemoattractant activity of vascular endothelial cells, 5) role of providing various growth factors, and temporary storage function.
Unlike other products generally known as CG paste, the acellular allo-dermal matrix product to be used in this study is made into a paste type for ease of use after freeze-drying and granulation process after undergoing the process of degreasing of the same kind of dermis . Conventional sheet-type products can not be applied to curved wounds, they must be cut and rehydrated during use, while CG paste is easy to apply to curved wounds and can be applied directly to the desired wound area without rehydration It is expected to be a ready-to-use product with similar clinical effects to existing acellular allo-dermal matrix.
The purpose of this study is to evaluate the efficacy and safety of wound sizing and completeness in chronic window treatment, and to confirm the superiority of area reduction in CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and form-dressing companion groups.
- Conditions
- Chronic Wound
- Being tested
- application of CG Paste+EasyFoam, application of EasyFoam
- Keywords
- ADM, acellular dermal matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of CG Paste+EasyFoamDevice
Prior to application of CG paste, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. After this, hemostasis is performed by an electrocoagulator and the medical device is applied to the affected area. During the procedure, remove the packaging material and remove the syringe to remove the protective cap in front of the syringe. Slowly push the syringe plunger and apply the contents to the area where you want to use. Depending on the location and size of the wound area, an injection cap can be used. Apply CG paste and apply Easyfoam to finish the dressing.
application of EasyFoamDevice
Prior to applying EasyFoam, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. Marginal resection is performed until the necrotic tissue is removed sufficiently and pin point bleeding is seen on the wound. After that, hemostasis is done with an electrocoagulator and EasyFoam is applied to the affected area.
| Study group | Role | What they receive |
|---|---|---|
| CG Paste+EasyFoam | Experimental | The subjects assigned to the test group through random assignment will receive the wound treatment by applying CG Paste and EasyFoam. CG Paste is a medical device currently marketed in CGBio.It is a free-flowing, acellular allogeneic dermis processed from human tissue skin, and then granulated and homogenized. This increases the water content and viscosity of the micronized ADM particles mixed with the gelatin sol carrier to protect the wound area and maintain the wet environment by applying to the desired wound area.It contains collagen, elastin and various growth factors in the dermis and has excellent tissue compatibility compared to the heterogeneous or synthetic material, so that the immune rejection is hardly observed in the graft site.
It also contains collagen, elastin, fibronectin, laminin, and proteoglycans, which are components of the human skin, to help the interaction between normal cells and extracellular matrix. Receives: Device: application of CG Paste+EasyFoam |
| EasyFoam | Active comparator | Subjects randomly assigned to the control group receive EasyFoam treatment for wound healing.
The foam has excellent moisture permeability, absorbs a large amount of exudates, and prevents scar formation to minimize scar formation. Receives: Device: application of EasyFoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound reduction rate
At 12 weeks after the application of the medical device, the wound reduction At 12 weeks after the application of the medical device, the wound reduction rate
Measured: 12 weeks
Secondary outcomes (5)
Complete healing rate
Complete healing rate after 12 weeks of medical device application
- Definition of complete healing: A complete healing is defined as a state in which the skin is completely reepithelialized and the skin is completely closed. Additional operations such as skin grafting, flap surgery, primary suture, etc. are not performed. (definition of complete healing:
Measured: 12 weeks
Period of time to complete healing
Period of time from medical device application to complete healing
- Definition of complete healing: A complete healing is defined as a state in which the skin is completely reepithelialized and the skin is completely closed. Additional operations such as skin grafting, flap surgery, primary suture, etc. are not performed.
Measured: The period to complete healing(through study completion, an average of 12 weeks)
Step of granulation tissue
Step for 12weeks of granulation tissue (The steps of granulation tissues are visualized by the following criteria, and the steps are recorded separately from A-E)
- A: Skin intact or partial thickness wound
- B: Bright, beefy red; 75% to 100% of wound filled \& or tissue overgrowth
- C: right, beefy red; < 75% \& > 25% of wound filled
- D: Pink, \&/or dull, dusky red \& or fills ≤ 25% of wound
- E: No granulation tissue present
Measured: 12 weeks
The time it took to reach granulation tissue formation
The period of time required for granulation tissue formation to reach 100%
Measured: The period of time required for granulation tissue formation to reach 100% (through study completion, an average of 12 weeks)
Level of tissue exposed after 12 weeks of medical device application
After 12 weeks of medical device application, the level of exposed tissue is divided into partial thickness skin, full thickness skin, subcutaneous, deep fascia, muscle, tendon, bone, and joint, and the distribution is compared.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start5 Apr 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Hanyang University, St Vincent's Hospital
- Responsible party
- Principal investigator, Sang Wha Kim, Seoul National University Hospital
- Investigators
- Sang Wha Kim, Ph.D, Principal investigator, Seoul National University HospitalYoun Hwan Kim, Ph.D, Principal investigator, Hanyang UniversityHyung Sup Shim, Ph.D, Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019639
- Sponsor's protocol ID
- 2017-02
- Status last verified
- Jul 2019
- First submitted
- 3 Jun 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Efficacy and Safety of Paste Type Acellular Dermal Matrix in Chronic Wound Healing
- ClinicalTrials.gov ID
- NCT04019639
- Acronym / sponsor ID
- 2017-02
- Conditions
- Chronic Wound
- Keywords
- ADM, acellular dermal matrix
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Hanyang University, St Vincent's Hospital
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 15 Jul 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of wound sizing and completeness in chronic window treatment, and to confirm the superiority of area reduction in CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and form-dressing companion groups.
Detailed description
wound refers to a condition in which the skin is damaged by a cause. In general, open wound rather than closed wound requires active treatment. It is important to make sure that the wound are cured early and through proper treatment. If the wound is open for a long time, secondary complications such as infection can occur and are easy to transition to chronic wound. Chronic wound refers to an idea that does not heal after a period of time after a normal wound healing process, which is usually defined as if it does not heal for more than three to four weeks. 1. These chronic wound include diabetic foot ulcer, pressure ulcer, vascular ulcer, etc. In addition, with the recent aging of the population, the proportion of elderly patients increases, and the proportion of chronic wound where even simple surgical wound does not heal normally, resulting in increased expenditure on health care and decreased quality of life for patients.
Biotechnical dermal transplantation material, including acellular dermal matrix, are known to be more effective in wound healing than conventional wound treatments.
The mechanism of action of acellular matrices including acellular dermal matrix, is as follows: 1) it functions as a support for cell growth and granulation tissue formation, 2) has receptors capable of attaching to fibroblasts, 3) induction of angiogenesis, 4) chemoattractant activity of vascular endothelial cells, 5) role of providing various growth factors, and temporary storage function.
Unlike other products generally known as CG paste, the acellular allo-dermal matrix product to be used in this study is made into a paste type for ease of use after freeze-drying and granulation process after undergoing the process of degreasing of the same kind of dermis . Conventional sheet-type products can not be applied to curved wounds, they must be cut and rehydrated during use, while CG paste is easy to apply to curved wounds and can be applied directly to the desired wound area without rehydration It is expected to be a ready-to-use product with similar clinical effects to existing acellular allo-dermal matrix.
The purpose of this study is to evaluate the efficacy and safety of wound sizing and completeness in chronic window treatment, and to confirm the superiority of area reduction in CG Paste and form-dressing as compared to form-dressing alone groups and CG Paste and form-dressing companion groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG Paste+EasyFoam | Experimental | Device: application of CG Paste+EasyFoamThe subjects assigned to the test group through random assignment will receive the wound treatment by applying CG Paste and EasyFoam. CG Paste is a medical device currently marketed in CGBio.It is a free-flowing, acellular allogeneic dermis processed from human tissue skin, and then granulated and homogenized. This increases the water content and viscosity of the micronized ADM particles mixed with the gelatin sol carrier to protect the wound area and maintain the wet environment by applying to the desired wound area.It contains collagen, elastin and various growth factors in the dermis and has excellent tissue compatibility compared to the heterogeneous or synthetic material, so that the immune rejection is hardly observed in the graft site. It also contains collagen, elastin, fibronectin, laminin, and proteoglycans, which are components of the human skin, to help the interaction between normal cells and extracellular matrix. |
| EasyFoam | Active comparator | Device: application of EasyFoamSubjects randomly assigned to the control group receive EasyFoam treatment for wound healing. The foam has excellent moisture permeability, absorbs a large amount of exudates, and prevents scar formation to minimize scar formation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 19 years
- Patients with skin defect from full-thickness skin defect to bone exposure level after debridement of wound
- Chronic wounds that have not been healed despite adequate treatment for more than 3 weeks after wounding
- At the time of the study, patients with a wound size of 4 cm 2 or more
Key exclusion criteria (7 listed)
- Patients with superficial or partial thickness skin defect
- osteomyelitis patient
- An undermining wound, tunneling wound, which can not measure the exact depth, can be used if the wound is open wound due to debridement of wound.
- Patients who exceeded 12% of HbA1c within 3 months before participating in the study
- Patients with serum creatinine concentration of 3.0 mg / dL or more within 30 days before the study
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 |
|---|---|---|
| application of CG Paste+EasyFoamPrior to application of CG paste, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. After this, hemostasis is performed by an electrocoagulator and the medical device is applied to the affected area. During the procedure, remove the packaging material and remove the syringe to remove the protective cap in front of the syringe. Slowly push the syringe plunger and apply the contents to the area where you want to use. Depending on the location and size of the wound area, an injection cap can be used. Apply CG paste and apply Easyfoam to finish the dressing. | Device | CG Paste+EasyFoam |
| application of EasyFoamPrior to applying EasyFoam, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. Marginal resection is performed until the necrotic tissue is removed sufficiently and pin point bleeding is seen on the wound. After that, hemostasis is done with an electrocoagulator and EasyFoam is applied to the affected area. | Device | EasyFoam |
Primary outcome
wound reduction rate
Time frame: 12 weeks
At 12 weeks after the application of the medical device, the wound reduction At 12 weeks after the application of the medical device, the wound reduction rate
5 secondary outcomes
Complete healing rate
Time frame: 12 weeks
Period of time to complete healing
Time frame: The period to complete healing(through study completion, an average of 12 weeks)
Step of granulation tissue
Time frame: 12 weeks
The time it took to reach granulation tissue formation
Time frame: The period of time required for granulation tissue formation to reach 100% (through study completion, an average of 12 weeks)
Level of tissue exposed after 12 weeks of medical device application
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
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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.
Sang Wha Kim, Ph.D principal investigator
Seoul National University Hospital
Youn Hwan Kim, Ph.D principal investigator
Hanyang University
Hyung Sup Shim, Ph.D principal investigator
St Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of CG Paste+EasyFoam and application of EasyFoam in people with Chronic Wound, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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 15 Jul 2019. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Wha Kim, Ph.D (82-2-2072-2374, sw1215@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound reduction rate (time frame: 12 weeks). 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 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.