Application of HD amniotic membrane to Refractory skin ulcer and the emergency field

JRCT ID: jRCTs042220007

Registered date:25/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Regeneration of Skin, Refractory skin ulcer, Open wound of the abdominal wall
• Date of first enrollment: 25/04/2022
• Target sample size: 24
• Study type: Interventional

Intervention(s)

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 amniotic membrane is dropped off, HD amniotic membrane can be added.
[Regeneration of Skin on severe burns of large necrotic tissue resection site]
1)After anesthesia, we perform sufficient debridement such as removal of defective granulation tissue, necrotic tissue and foreign matter in the wound. A HD amniotic membrane (with mesh processing etc.) is attached to the skin defect site, and we cover it with trex gauze coated with gentamicin ointment.
2)Cover the wound with a clean gauze and fix it with a bandage. In addition, if necessary, Negative Pressure Wound Therapy (NPWT) (50-125 mmHg, continuous) is used.
3)Remove the bandage and gauze and evaluate the granulation growth of the wound(When the wound infection is combined, the bandage and gauze are removed), and repeat 1) -2) if necessary.
4)Skin grafting is performed when good granulation growth is confirmed at the skin defect site. Skin is collected from the patient's healthy skin using a dermatome to a thickness of 14-16/1000 inch.
5)Three or six times the mesh of skin grafts collected using a mesher.
6)Place the skin graft on the granulation tissue and fix it with the surrounding skin with 3-0 or 2-0 nylon.
7)Place the non-stick silicone gauze coated with gentamicin sulfate on the skin graft, place the gauze moistened with saline on it, and finally put the dry gauze on it and tie over. If necessary, give negative pressure wound therapy (NPWT : 75-100 mmHg, continuous).
8)One week later, open the tie over (or remove NPWT) and observe the wound.
9)Continue treatment with gentamicin or azunol sulfate until complete epithelialization of the wound after tie over or NPWT. Add skin grafts if necessary.

[Refractory skin ulcer]
1)After anesthesia, we perform sufficient debridement such as removal of defective granulation tissue, necrotic tissue, infected tissue, and foreign matter in the wound, and sufficiently stop bleeding.
2)We take pictures of the wound and record the condition of the skin defect as an image.
3)A HD amniotic membrane (mesh processing etc.) is attached to the skin defect site, and we cover it with Polyurethane dressing (Hydrosite(R)) etc. coated with gentamicin ointment.
4)In addition, if necessary, Negative Pressure Wound Therapy (NPWT) (50-125 mmHg, continuous) is used.
5)If there are no signs of infection, we continue NPWT. We evaluate the granulation growth of the wound and repeat 1) -4) if necessary.
6)Skin grafting is performed when good granulation growth is confirmed at the skin defect site. Skin or Flap are collected from the patient's healthy skin using a dermatome to a thickness of 14-16/1000 inch.
7)Three or six times the mesh of skin grafts collected using a mesher.
8)Place the skin graft on the granulation tissue and fix it with the surrounding skin with 3-0 or 2-0 nylon.
9)Place the non-stick silicone gauze coated with gentamicin sulfate on the skin graft, place the gauze moistened with saline on it, and finally put the dry gauze on it and tie over. If necessary, give negative pressure wound therapy (NPWT : 75-100 mmHg, continuous).
10)One week later, open the tie over (or remove NPWT) and observe the wound.
11)Continue treatment with gentamicin or azunol sulfate until complete epithelialization of the wound after tie over or NPWT. Add skin grafts or flap formation if necessary.

[Open wound that is difficult to close with exposed intestinal tract]
1)After general anesthesia, wash the exposed intestinal tract, intra-abdominal organs and abdominal wall with saline.
2)Remove defective granulation tissue and foreign matter from the wound, stop bleeding, and wash again with saline.
3)Take a picture of the wound with a digital camera and record the color tone of the intestinal tract and the state of granulation tissue as an image.
4)Affix HD amniotic membrane on the exposed intestinal tract and cover it with gauze moistened with saline (wet-to-wet dressing).
5)Gauze replacement should be repeated as necessary by observing the amount of exudate and contamination of the wound.
6)If the HD amniotic membrane has peeled off from the wound surface, add a new one.
7) Perform split-thickness skin grafting when granulation grows on the exposed intestinal tract.Place the skin graft on the intestinal tract and fix it with the surrounding skin with 5-0 nylon, or fix it with the granulation tissue on the intestinal tract with 6-0 nylon.If suture cannot be fixed, use Beriplast P Combi-Set Tissue adhesion for tissue adhesion to fix it to the wound surface.
8)Place the non-stick silicone gauze coated with gentamicin sulfate on the skin graft, place the gauze moistened with saline on it, and finally put the dry gauze on it and tie over. If necessary, give negative pressure wound therapy (NPWT : 75-100 mmHg, continuous).
9)One week later, open the tie over (or remove NPWT) and observe the wound.
10)Continue treatment with gentamicin or azunol sulfate until complete epithelialization of the wound after tie over or NPWT. Add skin grafts if necessary.

Outcome(s)

Primary Outcome

[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 Outcome

(1)Degree of skin graft / flap engraftment (epithelialization) at creation opening date after Skin graft / flap operation in each case(Area ratio of skin grafts where epithelialization was obtained): Cases in which 80% or more of epithelialization is obtained are regarded as "effective cases", and the number of effective cases is counted.
If there is a control place, the comparison between control area and HD treated area is used to judge "effective".

(2)Evaluation by researchers at each evaluation period for the following items
1.Subjective symptoms
2.Objective findings
3.Wound findings
<Common Items>
1)Granulation tissue growth at the wound edge
2)Granulation color
3)Presence or absence of defective granulation
4)HD-AM adhesion and degradablity
5)graft / flap engraftment (epithelialization)
6)Vulnerability
7)Bleeding
8)Tissue scarring
9) infection
10)Wound digital camera image
11)Other comments

[Regeneration of Skin on severe burns of large necrotic tissue resection site]
Pulus bellow the above common Item
1.biopsy

[Open wound that is difficult to close with exposed intestinal tract]
Pulus bellow the above common Items
1.Exposed intestinal condition
2.Presence or absence of EAF

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

[Regeneration of Skin on severe burns of large necrotic tissue resection site]
1) Age:Patients over 20 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 Invasion II degree burn and Invasion 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 understood 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, 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.

[Refractory skin ulcer]
1)Age:Patients over 20 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 understood 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 20 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 understood 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, 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.

Exclude 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.

Related Information

• Primary Sponsor: Shimizu Tadamichi