Efficacy and Safety of X A-DERM™ Microsurfaced Acellular Dermal Matrix (mADM) for Enhancing Wound Healing Following Mohs Micrographic Surgery (MMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality.
研究概览
简要总结
The goal of this single-arm clinical trial is to learn about the effectiveness and safety of the X A-DERM™ mADM in promoting wound healing and improving scar formation after MMS surgery for removing BCC, SCC, or MIS lesions on the face, head, and upper limbs. The main questions it aims to answer are how well this intervention works and what is the safety profile.
The primary hypothesis is that the use of X A-DERM™ will result improved wound healing and scar formation after 60 days post-procedure.
Participants will undergo MMS surgery to remove BCC, SCC, or MIS lesions, and then will receive the X A-DERM™ mADM graft at the surgical site. Participants will return to the office four additional times for the clinician to collect data on their wound healing. This will involve taking pictures of the wound, conducting clinical assessments (CROs), and documenting the patient's reported outcomes (PROs).
详细描述
The objective of this trial is to evaluate the efficacy and safety of X A-DERM™ mADM for enhancing wound healing and improving scar formation following MMS for removal of BCC, SCC, or MIS lesions in the face, head, upper and lower extremities, and trunk in adults 18 to 85 years of age who are scheduled to undergo elective MMS. After complete excision of the tumor and removal of all cancerous tissue, reconstruction immediately follows with placement of the mADM into the defect. Subjects will receive the standard of care for post-op and at-home wound care and will be recalled for a total of 5 in-office visits to evaluate wound healing. This is a single-arm, open-label, prospective clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all the following criteria to be entered into the study:
- •Between 18 and 85 years of age, inclusive
- •Subject in good health, or with stable treated medical condition, as determined by the investigator.
- •Scheduled to undergo elective Mohs surgery to remove a single biopsy-proven basal cell carcinoma (BCC), squamous cell carcinoma (SCC), or melanoma in situ (MIS) lesion on the head, face, or upper extremity that is amenable to Mohs surgery.
- •Tumor location and size meets the following criteria for immediate MMS:
- •Largest total surface area of ≤16cm2 and smallest total surface area per PI discretion.
- •Depth with majority of tumor excision at least to subcutaneous tissue.
- •Adequate dermal contract with graft.
- •Willing and able to complete and comply with procedures, protocol requirements, and instructions, including self-performed wound care and completion of all required visits.
- •Able to speak, read, write, and understand the language of the informed consent form (ICF) and study questionnaires.
- •Willingness and ability to understand the risks, benefits, and alternatives to participation, and give informed consent.
排除标准
- •Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
- •History of wound abnormalities or any other findings that would impede participation in the trial, as per PI discretion.
- •Post-operative defects superficial and deemed not appropriate for second intention healing, as determined by the investigator.
- •Pregnant, lactating/breast feeding, or planning a pregnancy. A negative urine pregnancy test will be required at screening for female subjects of childbearing potential; a woman will be considered to be of childbearing potential unless she has had a tubal ligation, total hysterectomy, bilateral oophorectomy, or is postmenopausal (without a menstrual period for at least one year).
研究组 & 干预措施
Recipient of the X A-DERM™ mADM
The participants will receive the X A-DERM™ mADM following MMS for removal of BCC, SCC, or MIS lesions in the face, head, or upper extremities. After complete excision of the tumor and removal of all cancerous tissue, reconstruction immediately follows with placement of the mADM into the defect. Subjects will receive the standard of care for post-op and at-home wound care and will be recalled for a total of 5 in-office visits to evaluate wound healing.
干预措施: A microsurfaced ADM (acellular dermal matrix) (Device)
结局指标
主要结局
To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality.
时间窗: Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60).
This will be done by requesting patients and clinicians to complete POSAS assessments, the Patient and Observer Scar Assessment Scale. The POSAS contains two assessments. The first assessment captures patients' views on scar pain, itchiness, if the scar color is different, if the scar is more stiff, is the thickness of the scar different, and is the scar irregular by ranking their answer from a scale of 1-10. 1 being "no, no complaints" and 10 being "yes, worst imaginable". The second assessment is the clinician's portion. It involves objective scoring based on standardized criteria for characteristics such as vascularity, pigmentation, thickness, relief, pliability, and surface area using a scale from 1-10 1 being "Normal skin" and 10 being "worst scar imaginable".
To evaluate the effectiveness of X A-DERM™ mADM on clinician- and patient-based assessments and objective measurements of wound healing and scar quality.
时间窗: Visit 1(Day 0), Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60).
This will be done by capturing digital photographs. Digital photographs of the wound bed site will be acquired pre- and post-placement of the mADM perioperatively and at follow-up visits.
次要结局
- To evaluate the effectiveness of X A-DERM™ mADM on objective metrics of wound healing based on physical measurements as well as subjective assessments on wound management, pain, functional outcomes, quality of life, and cosmetic appearance(Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), and Visit 5 (Day 60).)