Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
21 maj 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Colorado
-
Johnstown, Colorado, Förenta staterna, 80534
- Nadora Healthcare
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wound Adhesion Scoring
Tidsram: 8-12 weeks post-operation
|
Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
|
8-12 weeks post-operation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dry Time
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mesh application time
Tidsram: During the procedure
|
Time to apply Mesh in seconds
|
During the procedure
|
|
Glue Application Time
Tidsram: During the procedure
|
Time to apply glue
|
During the procedure
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Scott Dupar, Physician - Doctor of Medicine, Nadora Healthcare
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 april 2025
Primärt slutförande (Faktisk)
18 mars 2026
Avslutad studie (Faktisk)
18 mars 2026
Studieregistreringsdatum
Först inskickad
7 maj 2026
Först inskickad som uppfyllde QC-kriterierna
21 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- MED-2024-DIV71-003
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Sårförslutning
-
HealthpointAvslutadUppföljning av Acute Wound Scar StudyFörenta staterna