Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
2026年5月21日 更新者：Medline Industries
surgical adhesive systems are used to close surgical cuts and simple skin wounds.
This system is a non-invasive option, meaning it can be used instead of stitches or staples.
Because these products do not require stitching deep into the skin, they can reduce the time it takes to close a wound and may reduce stress or damage to the skin edges.
研究概览
地位
完全的
详细说明
The OptiClose surgical adhesive system combines a liquid adhesive with a self-adhering mesh for the closure of surgical incisions and simple lacerations. It acts as a demonstrated noninvasive alternative to skin sutures and staples.
The OptiClose and Dermabond topical skin adhesives combine a self-adhering, pressure sensitive adhesive (PSA), polyester-based mesh (for incisions requiring a mesh), as well as a simple non mesh application system (for incisions that do not require a mesh) for temporarily adjoining the approximated skin edges of an incision, and a 2-octyl cyanoacrylate liquid adhesive formulation for final skin closure. By sparing long intracutaneous sutures, wound closure time is significantly reduced and wound edge ischemia potentially diminished. The purpose of this study is to conduct a two arm, prospective, randomized control trial by which participants will be randomly assigned to either receive the Dermabond wound closure adhesive or the OptiClose wound closure adhesive in participants undergoing the closure of any subcutaneous tissue following surgical site incisions.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
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。
学习地点
-
-
Colorado
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Johnstown、Colorado、美国、80534
- Nadora Healthcare
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-
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:
- Are able to understand and willing to carry out instructions for this study.
- Full thickness surgical incision requiring subcutaneous closure.
Exclusion Criteria:
- Known sensitivities/allergies to the ingredients contained in the products. Individuals with a self-reported Type IV hypersensitivity reaction to cyanoacrylates (namely acrylates).
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：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：larger incisions requiring mesh are randomized to two a Medline product and the other a comparator
In the first arm, larger incisions (greater than 20cm) requiring mesh are randomized to either OptiClose Secure or Dermabond Prineo.
Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits.
Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application.
Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise.
The study involved an overall duration of approximately 4-6 months[SR1] [NS2] , with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window.[
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Participants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics.
Incisions requiring mesh support (>20 cm) are closed with adhesive plus mesh using one of the assigned products.
其他名称：
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实验性的：smaller incisions not requiring mesh are closed using adhesive only with participants randomized
In the second arm, smaller incisions (19 cm or smaller) not requiring mesh are closed using cyanoacrylate-based adhesive ("glue") only, with participants randomized to OptiClose Rapid or Dermabond Advanced.
Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits.
Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application.
Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise.
The study involved an overall duration of approximately 4-6 months.
, with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window
|
Participants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics.
Incisions not requiring mesh (≤19 cm) are closed using cyanoacrylate-based adhesive alone.
Product assignment is randomized within each incision category.
其他名称：
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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 |
|---|---|---|
|
Wound Adhesion Scoring
大体时间：8-12 weeks post-operation
|
Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
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8-12 weeks post-operation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dry Time
大体时间：During the procedure
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Timing in seconds to start once the applicator has contacted the skin and ends when the application of the liquid adhesive is complete and is no longer wet to the touch.
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During the procedure
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Modified Hollander Cosmesis Score (Total Score)
大体时间：8-12 weeks post-operation
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Cosmetic appearance of the wound as identified by the Modified Hollander Wound Evaluation Scale.
The Modified Hollander Cosmesis Scale consists of multiple components assessed as binary outcomes (1 = absence, 0 = presence).
Individual item scores are summed to generate a total score per participant (overall cosmesis score) The total score ranges from 1 to 6, with higher scores indicating better cosmetic outcome.
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8-12 weeks post-operation
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Participant Satisfaction With Cosmetic Outcome
大体时间：8-12 weeks post-operation
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Participant satisfaction with the cosmetic outcome was assessed using a numeric rating scale ranging from 1 to 10, where lower scores indicate greater satisfaction.
This assessment was collected alongside the Modified Hollander cosmesis evaluation.
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8-12 weeks post-operation
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Operator Satisfaction Score (1-10 Scale)
大体时间：8-12 weeks post-operation
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Operator satisfaction with the cosmetic outcome was assessed using a numeric rating scale ranging from 1 to 10, where lower scores indicate greater satisfaction.
This assessment was collected alongside the Modified Hollander cosmesis evaluation.
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8-12 weeks post-operation
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Counts of Surgical Site Infections
大体时间：8-12 weeks post-operation
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The counts will be collected of participants experiencing surgical site infections (SSIs) and recorded for each subject (as occurring within 30 days of treatment) as per the CDC guidelines.
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8-12 weeks post-operation
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Counts of Inflammatory reactions
大体时间：8-12 weeks post-operation
|
The counts will be collected of participants experiencing Inflammatory reactions and recorded for each subject as per the ICDRG guidelines.
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8-12 weeks post-operation
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mesh application time
大体时间：During the procedure
|
Time to apply Mesh in seconds
|
During the procedure
|
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Glue Application Time
大体时间：During the procedure
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Time to apply glue
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During the procedure
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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：Scott Dupar, Physician - Doctor of Medicine、Nadora Healthcare
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 (实际的)
2025年4月2日
初级完成 (实际的)
2026年3月18日
研究完成 (实际的)
2026年3月18日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年5月29日
上次提交的符合 QC 标准的更新
2026年5月21日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- MED-2024-DIV71-003
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.