Skin Subs vs Secondary Intention
2026年5月11日 更新者:Baylor Research Institute
Skin Substitutes Versus Secondary Intention Healing After Mohs Micrographic Surgery
The purpose of this study is to compare two ways of caring for wounds after Mohs micrographic surgery (MMS) for skin cancer using skin substitutes and secondary intention healing, to determine which option leads to better healing after Mohs surgery.
研究概览
地位
尚未招聘
详细说明
This is a randomized-controlled trial comparing two ways of caring for wounds after Mohs micrographic surgery for skin cancer: skin substitutes, which are special wound-healing materials that may help wounds heal, and secondary intention healing, a common method in which wounds are allowed to heal on their own.
This research is being done because we do not yet know which option leads to better healing after Mohs surgery.
Patients will be randomized into one of two groups and receive either the skin substitute or undergo secondary intention healing.
研究类型
介入性
注册 (估计的)
50
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Umer Nadir, MD
- 电话号码:214-820-2361
- 邮箱:umer.nadir@bswhealth.org
学习地点
-
-
Texas
-
Dallas、Texas、美国、75246
- Baylor University Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults 18 and older undergoing Mohs micrographic surgery
- Wounds deemed clinically appropriate for secondary intention healing
- Ability to adhere to daily wound care and follow-up visits
- Willingness to consent to standardized medical photography
Exclusion Criteria:
- Wounds requiring flap or graft reconstruction for structural/functional reasons
- Active wound infection at time of reconstruction
- Known allergy to any component of the skin substitute
- Severe immunosuppression in which either approach may pose undue risk
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:控制组
|
Standard secondary intention healing with daily wound care only.
|
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有源比较器:干预组
|
Application of a commercially available skin substitute (e.g., acellular dermal matrix or fish-skin xenograft) to the wound base followed by routine daily wound care.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cosmetic Outcome Assessments
大体时间:12 weeks
|
Compare cosmetic outcomes at 12 weeks between wounds treated with (1) a skin substitute and (2) secondary intention healing alone.
This will be done by a group of blinded independent reviewers using standardized photographs and the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable".
|
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete Wound Healing
大体时间:12 weeks
|
Assess the amount of time to took for the wound to heal completely, also defined as full epithelialization.
This will be compared using a t-test model or the Mann-Whitney U tests.
A t-test model uses an standard statistic test that is used to determine if there is significant differences between two groups.
The Mann-Whitney U tests is a rank-sum test that is used to determine if there is a difference between two different groups.
|
12 weeks
|
|
Pain Scores
大体时间:12 weeks
|
Evaluate the patient-reported pain during the first 2 weeks of healing and weekly, at follow-up visits, until wound closure.
Patients will verbally rating their pain on a scale of 1-10 where 1 is no pain and 10 is severe pain.
Patient will keep a record of their daily pain levels and share the scores at their weekly follow-up visits.
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12 weeks
|
|
Rate of Complications
大体时间:12 weeks
|
To determine the rate of complication and assess for infection, bleeding, hypergranulation, and unplanned interventions.
During the follow-up visits the physician will conduct a visual assessment for these items and will use a chi-square or Fisher's exact tests.
A Chi-Square test is a statistical tool that is used to determine if there is a different between expected and observed frequences in one or more category.
Fisher's exact test is a tool used to determine if there are non-random associations between two categorical variables.
|
12 weeks
|
|
Scar Appearance
大体时间:12 weeks
|
To evaluate the patient-reported scar satisfaction by patients the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable".
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12 weeks
|
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Treatment-Related Resource Consumption
大体时间:12 weeks
|
To evaluate the resource utilization and cost of the number of clinic visits by reviewing the patients electronic health record
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12 weeks
|
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Treatment-Related Resource Consumption
大体时间:12 weeks
|
To evaluate the resource utilization and cost of dressing supplies by reviewing the patients electronic health record.
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12 weeks
|
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Patient Productivity Loss
大体时间:12 weeks
|
To assess the loss of productivity due to patient-reported time off work, if feasible.
This will be done by patients verbal self-report.
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stan Tolkachjov, MD、Baylor Scott and White Health
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 Oct;67(4):531-50. doi: 10.1016/j.jaad.2012.06.009. Epub 2012 Sep 5.
- Alrubaiy L, Al-Rubaiy KK. Skin substitutes: a brief review of types and clinical applications. Oman Med J. 2009 Jan;24(1):4-6. doi: 10.5001/omj.2009.2.
- Esmaeili A, Biazar E, Ebrahimi M, Heidari Keshel S, Kheilnezhad B, Saeedi Landi F. Acellular fish skin for wound healing. Int Wound J. 2023 Sep;20(7):2924-2941. doi: 10.1111/iwj.14158. Epub 2023 Mar 16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 026-109
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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