A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 4cm
- •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.
排除标准
- •The subject's wound site is smaller than 4cm
- •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.
- •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.
结局指标
主要结局
Pain Score
时间窗: Baseline
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 1
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 2
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 3
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 4
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 5
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 6
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 7
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 8
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 12
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
时间窗: Week 16
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Number of Participants with Infection
时间窗: Through week 16
Number of participants that developed a wound infection
Number of Participants with Allergic Reaction
时间窗: Through week 16
Number of participants with an allergic reaction to the intervention
Number of Treatment-Related Adverse Events
时间窗: Through week 16
Number of treatment-related adverse events
Number of Unscheduled Visits for Wound Bleeding
时间窗: Through week 16
Number of participants that had an unscheduled visit for wound bleeding
次要结局
- Time Until Wound Closure(Through week 16)
- Time Until of Wound Closure(Through week 16)
- Percentage of Re-epithelialization(Week 1, week 4, week 8, week 12, week 16)