Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
21. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Colorado
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Johnstown, Colorado, Forenede Stater, 80534
- Nadora Healthcare
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.[
|
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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Wound Adhesion Scoring
Tidsramme: 8-12 weeks post-operation
|
Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
|
8-12 weeks post-operation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dry Time
Tidsramme: During the procedure
|
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)
Tidsramme: 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
Tidsramme: 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.
|
8-12 weeks post-operation
|
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Operator Satisfaction Score (1-10 Scale)
Tidsramme: 8-12 weeks post-operation
|
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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mesh application time
Tidsramme: During the procedure
|
Time to apply Mesh in seconds
|
During the procedure
|
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Glue Application Time
Tidsramme: During the procedure
|
Time to apply glue
|
During the procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Scott Dupar, Physician - Doctor of Medicine, Nadora Healthcare
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. april 2025
Primær færdiggørelse (Faktiske)
18. marts 2026
Studieafslutning (Faktiske)
18. marts 2026
Datoer for studieregistrering
Først indsendt
7. maj 2026
Først indsendt, der opfyldte QC-kriterier
21. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MED-2024-DIV71-003
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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