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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Johnstown、Colorado、アメリカ、80534
- Nadora Healthcare
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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実験的：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
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Wound Adhesion Scoring
時間枠：8-12 weeks post-operation
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Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
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8-12 weeks post-operation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dry Time
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：8-12 weeks post-operation
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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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mesh application time
時間枠：During the procedure
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Time to apply Mesh in seconds
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During the procedure
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Glue Application Time
時間枠：During the procedure
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Time to apply glue
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During the procedure
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Scott Dupar, Physician - Doctor of Medicine、Nadora Healthcare
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年4月2日
一次修了 (実際)
2026年3月18日
研究の完了 (実際)
2026年3月18日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月21日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- MED-2024-DIV71-003
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。