Amnion Membrane Powder Mohs Study

Официальное название

A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites

Обзор

The purpose of this research study is to test the safety of the amnion membrane powder to see if it improves wound healing in patients undergoing Mohs surgery on the scalp.

Подробное описание

The primary objective of this prospective, non-randomized, controlled study is to assess the safety of the human amnion membrane powder for enhanced wound healing properties in patients undergoing Mohs surgery resulting in full thickness wounds. The secondary objective is to evaluate the efficacy of the product relative to the standard of care treatment in a control cohort of subjects. The treatment site will be the wound created by the Mohs surgery in the treatment group. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.

Вмешательства

• Препарат Amnion Membrane Powder
  amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery
• Препарат Standard of Care
  aquaphor ointment applied during MOHS scalp surgery

Первичные конечные точки

• Number of Participants with Infection [Срок оценки: Through week 16]
• Number of Participants with Allergic Reaction [Срок оценки: Through week 16]
• Number of Treatment-Related Adverse Events [Срок оценки: Through week 16]
• Number of Unscheduled Visits for Wound Bleeding [Срок оценки: Through week 16]
• Pain Score [Срок оценки: Baseline]
• Pain Score [Срок оценки: Week 1]
• Pain Score [Срок оценки: Week 2]
• Pain Score [Срок оценки: Week 3]
• Pain Score [Срок оценки: Week 4]
• Pain Score [Срок оценки: Week 5]

Вторичные конечные точки (3)

• Time Until Wound Closure [Срок оценки: Through week 16]
• Time Until of Wound Closure [Срок оценки: Through week 16]
• Percentage of Re-epithelialization [Срок оценки: Week 1, week 4, week 8, week 12, week 16]

Критерии участия

Критерии включения

• The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2.
• The subject is willing to complete all follow-up evaluations required by the study protocol.
• The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless otherwise directed by the study surgeon or their surrogate
• The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
• The subject and/or guardian is/are able to read and understand instructions and give informed, voluntary, written consent.
• The subject is able and willing to follow the protocol requirements.

Критерии исключения

• The subject's wound site is smaller than 4cm2.
• The subject's wound site does not extend to the subgalea.
• The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology
• The subject has a microbiologically proven pre-existing local or systemic bacterial infection.
• The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.
• Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure that would preclude the indicated procedure.
• Hepatic disease or altered liver function as defined by ALT or AST value > 3 times the upper limit of normal and/or T. Bilirubin >1.5 mg/dL at screening.
• Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at screening, or ESRD.
• Hemoglobin <10.0 or >19.0 g/dL
• Untreated coagulopathy or platelet disorder, or INR > 1.6, PTT > 38 sec; PLT < 50,000 at screening.
• The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with complete re-epithelialization including but not limited to untreated malignancy, uncontrolled diabetes (HbA1c >10), autoimmune disease or other immunocompromised diseases, hematological diseases, peripheral artery diseases, and /or malnourishment with an albumin < 2.5.
• The subject currently uses illicit substances or has drug or alcohol dependency.
• The subject is unable to follow the protocol.
• The subject is taking medication known to have an effect on wound healing or skin pigmentation within 30 days prior to surgery (e.g. corticosteroids, retinoids etc.)
• The subject has a known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution.
• The subject is pregnant or lactating or intends to become pregnant during the study.
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist — Winston-Salem

Идентификаторы

NCT: NCT07680023 · IRB00151720

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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