Application of HD AM 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 AM is dropped off, HD AM can be added.

[Regeneration of Skin on severe burns of large necrotic tissue resection site]
1) After anesthesia, adequate debridement is performed, including removal of defect granulation tissue, necrotic tissue, and foreign bodies within the wound. A HD AM (with mesh finish, etc.) is placed over the skin defect, which is then covered with Trex gauze and suturatulle Gauze.
2) Cover the wound with clean gauze and secure with a bandage. Negative pressure wound therapy (NPWT) (70-125 mmHg, sustained) is also applied as needed.
3) Remove the bandages and gauze, evaluate the wound for granulation (remove the bandages and gauze if there is a complication of wound infection), and repeat steps 1)-2) as needed.
4) Once good granulation is confirmed in the skin defect, skin grafting is performed. Skin is harvested from the patient's healthy skin to a thickness of 14-16/1000 inches using a dermatome.
5) A mesh 3 to 6 times the size of the skin graft taken is harvested with a mesher.
6) The skin graft is placed over the granulation tissue and secured to the surrounding skin with 3-0 or 2-0 nylon.
7) The skin grafts sites should be managed with gauze-covered tie-over or local negative pressure closure (75-125 mmHg, continuous).
8) About 1week, the tie-over is opened (or NPWT is removed) and the wound site is observed.
9) After tie-over or NPWT, continue treatment with gentamicin or azunor sulfate until wound is completely epithelialized. Add skin grafts as needed.

[Refractry skin ulc]
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 AM (mesh processing etc.) is attached to the skin defect site, and which is then covered with Trex gauze and suture gauze.
4) In addition, if necessary, Negative Pressure Wound Therapy (NPWT) (75-125 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) A mesh 3 to 6 times the size of the skin graft taken is harvested with a mesher.
8) The skin graft is placed over the granulation tissue and secured to 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 : 75-125 mmHg, continuous).
10) About 1week, open the tie over (or remove NPWT) and observe the wound.
11) After tie-over or negative pressure closure, the wound should continue to be treated with gentacin or Azunor ointment until complete epithelialization. If necessary, an additional skin graft should be performed.

[Open wound that is difficult to close with exposed intestinal tract]
1) After general anesthesia, the exposed intestinal tract, abdominal organs,and abdominal wall are washed with saline solution.
2) Granulation tissues including necrotic wounds and foreign bodies are removed, the wound is stopped bleeding, and then washed again with saline solution.
3) The wound sites are photographed with a digital camera, and the color tone of the intestinal tract and the condition of the granulation are recorded as images.
4) A medical device HD AM is applied to the exposed intestinal tract and covered with gauze moistened with saline (wet to wet dressing).
5) The gauze is repeatedly changed as necessary while observing the amount of exudate and the state wound contamination.
6) If HD-AM is removed from the sound surface, add new HD AM.
7)Once a granulation has formed over the exposed bowel, a split thickness skin graft is performed. The graft is placed over the bowel and secured to the surrounding skin with 5-0 nylon sutures or to the granulation over the bowel with 6-0 nylon sutures. If suture fixation is not possible, fix the graft to wound surface with Veriplast P Combset for tissue adhesion.
8)The grafted skin is covered with gauze and either tied over or managed with local negative pressure closure (75-125 mmHg, continuous).
9)The tie-over or negative pressure closure site should be opened every week or so to observe the wound.
10) Wounds after tie-over or negative pressure closure should continue to be treated with gentacin or Azunor ointment until fully epithelialized. Skin grafting should be performed 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 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-Shrinkage of scars: Evaluate by "None" or "Yes". If "yes," the details noted should be taken into account.

9-Presence or absence of signs of infection: Evaluate by "no" or "yes". If "yes," the details described in the report should be taken into account.

10-Digital camera image of the wound

[Regeneration of skin on severe burns of large necrotic tissue resection site]
11-Biopsy (punch biopsy technique)

[Open wound that is difficult to close with exposed intestinal tract]
12-Condition of the intestinal tract (color tone, permeability of intra-abdominal organs, scarring, bleeding)
If "Yes", consider the description.
13-Presence or absence of EAF: Evaluate with "No" or "Yes". If "Yes", consider the description in the report.

Other comments
[Regeneration of skin on severe burns of large necrotic tissue resection site]
Comparison of the treatment course between the site treated with HD AM.

[Intractable skin ulcer]
When there is a coexisting site treated with a general covering material, Comparison of treatment progress and results with HD AM treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 18age 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 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.

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