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Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives

21. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Colorado
      • Johnstown, Colorado, Forente stater, 80534
        • Nadora Healthcare

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.[
Enhet: Evaluating wound closure products to close larger surgical site incisions
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 navn:
  • Dermabond
  • OptiClose
Eksperimentell: 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
Enhet: Evaluating wound closure products to close smaller surgical site incisions
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 navn:
  • Dermabond
  • Opticlose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.
During the procedure
Modified Hollander Cosmesis Score (Total Score)
Tidsramme: 8-12 weeks post-operation
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.
8-12 weeks post-operation
Participant Satisfaction With Cosmetic Outcome
Tidsramme: 8-12 weeks post-operation
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
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.
8-12 weeks post-operation
Counts of Surgical Site Infections
Tidsramme: 8-12 weeks post-operation
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.
8-12 weeks post-operation
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.
8-12 weeks post-operation

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mesh application time
Tidsramme: During the procedure
Time to apply Mesh in seconds
During the procedure
Glue Application Time
Tidsramme: During the procedure
Time to apply glue
During the procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medline Industries

Etterforskere

  • Hovedetterforsker: Scott Dupar, Physician - Doctor of Medicine, Nadora Healthcare

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. april 2025

Primær fullføring (Faktiske)

18. mars 2026

Studiet fullført (Faktiske)

18. mars 2026

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • MED-2024-DIV71-003

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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