Regeneration of Skin, Refractory skin ulcer, Open wound of the abdominal wall
Conditions
Interventions
In consideration of the severity and research ethics of each disease, in the implementation of research, each medical institution seems to be optimal for each subject. If the HD AM is dropped off, HD
Sponsors
Doi Tomoaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Regeneration of Skin on severe burns of large necrotic tissue resection site] 1) Age:Patients over 18 years old (at the time of obtaining informed consent) 2)Severe burns that may require necrotic tissue resection (debridement) and subsequent skin grafting, such as wounds that are Depth II degree burn and Depth III degree burn. 3)Patients who are judged to be able to observe / inspect and investigate according to the research implementation plan. 4)Patients (the subjects) who have been able to understand the written explanation and who have agreed voluntarily. If the subject have been disagreeable consciousness, informed consent will be obtained from the proxy based on the Clinical Research Law. In this case, the proxy has been, [Refractory skin ulcer] 1)Age:Patients over 18 years old (at the time of obtaining informed consent) 2)Patients who are judged to have difficulty in wound closure during the acute phase (within 2 weeks). 3)Intractable cutaneous ulcers that may require necrotic tissue resection (debridement) and subsequent skin grafting, such as wounds that are Ischemic ulcers, vein static ulcers, collagen disease related ulcers, diabetic ulcers, vasculitis ulcers, after radiation treatment ulcers, trauma, burns and doner site in skin grafting. 4)Patients who are judged to be able to observe / inspect and investigate according to the research implementation plan. 5)Patients (the subjects) who have been able to understand the written explanation and who have agreed voluntarily based on the Clinical Research Law. [Open wound that is difficult to close with exposed intestinal tract] 1)Age:Patients over 18 years old (at the time of obtaining informed consent) 2)Patients with difficulty in abdominal wall closure during the acute phase (within 2 weeks) 3)Patients who have undergone laparotomy due to abdominal trauma, intra-abdominal infection, acute pancreatitis, intestinal ischemia, abdominal compartment syndrome, etc. and cannot close the abdomen after surgery. 4)Patients who are judged to be able to observe / inspect and investigate according to the research implementation plan. 5))Patients (the subjects) who have been able to understand the written explanation and who have agreed voluntarily. When obtaining the consent of a surrogate in accordance with the Clinical Research Act if the subject is in a conscious state where the consent of the subject himself/herself cannot be obtained. In this case, the proxy has been, a spouse, a guardian, or any other similar person, and has been considered to be able to represent the patient's will and interests in view of the substance and spiritual relationship.
Exclusion criteria
Exclusion criteria: [Regeneration of Skin on severe burns of large necrotic tissue resection site] 1)Patients whose doctors have judged that it is difficult to keep safe wound management throughout the study period. 2)Patients with active infections. 3)Patients who participated in other studies or clinical studies within 6 months (However, control patients who do not use Research reproduction Medical products, etc., research drugs or c medical devices.). 4)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception. 5)Patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor. [Refractory skin ulcer] 1)Patients whose doctors have judged that it is difficult to keep safe wound management throughout the study period. 2)Patients with active infections. 3)Patients who participated in other studies or clinical studies within 6 months (However, control patients who do not use Research reproduction Medical products, etc., research drugs or c medical devices.). 4)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception. 5)Patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor. [Open wound that is difficult to close with exposed intestinal tract] 1)Patients with necrotic tissue or definite infection in the wound. 2)Patients who already have EAF on the exposed intestinal tract. 3)Patients determined by a doctor to have difficulty continuing safe treatment over the duration of the study. 4)Patients with active infections. 5)Patients who plan to perform other surgery on the efficacy evaluation site during the study period (the study starts with the acquisition of consent). 6)Patients who participated in other studies or clinical studies within 6 months (However, control patients who do not use Research reproduction Medical products, etc., research drugs or c medical devices.). 7)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception. 8)Patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [Regeneration of Skin on severe burns of large necrotic tissue resection site] Cases with good granulation tissue growth on "the skin graft day" or cases with good granulation tissue growth on "the discharge day" are regarded as "effective cases". [Refractory skin ulcer] 1)Common refractory ulcer(Granulation tissue growth from HD amniotic membrane application to "skin grafting day"): Cases with good granulation growth during skin grafting / flaps are regarded as "effective cases", and the number of effective cases is counted. 2)Pressure ulcer(Days from application of HD amniotic membrane to epithelialization):Cases with 5 months or less days are regarded as "effective cases". [Open wound that is difficult to close with exposed intestinal tract] Number of days from application of HD amniotic membrane to skin grafting:Cases with 28 days or less are regarded as "effective cases". | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Degree of graft/epithelialization (percentage of the area of the graft where epithelialization is achieved): Patients who have achieved at least 80% epithelialization are considered effective cases. If there is a control area, "effective" shall be judged by comparing the control area with the control area. 2) Researcher's evaluation of the following items at each evaluation period. 1. Subjective symptoms Pain: The following 3 levels of pain will be evaluated based on the Numerical Rating Scale (NRS) 0: Mild (NRS3 or less) 1: Moderate (NRS4 6) 2: Strong (NRS7 or more) Other subjective symptoms: Evaluate "None" and "Yes". If "Yes," the detailed information provided should be taken into account in the evaluation. 2.Wound findings Common items 1-Wound granulation: Evaluate on the following 3 levels: 0: Good 1: Slight 2: None 2-Color tone of the intra-wound tissue: Evaluate in the following 3 levels: 0: Good 1: Normal 2: Poor 3-Presence or absence of bad granulation: Evaluate on the following 3 levels: 0: No bad granulation 1: After removal of bad granulation 2: Bad granulation that cannot be removed remains 4-Condition of HD AM: Evaluate on the following 3 levels. 0: Attached and granulation is growing 1: HD AM attached but no granulation is observed 2: HD AM has completely fallen off 5-Skin grafting (epithelialization): Evaluate on the following 3 levels: 0: Good = grafted Good=Growth is present (epithelialization is observed) 1: Normal=The graft is attached, but no epithelialization from the graft/cutaneous valve is observed (signs of epithelialization are present) 2: Poor=The graft/cutaneous valve is completely dislodged (no epithelialization is observed) 6-Fragility: Evaluate by "none" or "yes". In case of "Yes", the detailed information provided should be taken into account. 7-Easily hemorrhagic: Evaluate by "none" or "yes". If "yes," the details described in the report should be taken into account. 8-Shrinka | — |
Contacts
Public ContactMotonori Okabe
University of Toyama
Outcome results
None listed