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The safety of Prineeo skin tissue adhesive for incision closure in total knee arthroplasty: a single center, prospective, cohort study in China

The safety of Prineeo skin tissue adhesive for incision closure in total knee arthroplasty: a single center, prospective, cohort study in China

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084061
Enrollment
Unknown
Registered
2024-05-09
Start date
2024-05-15
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total knee arthroplasty incision closure

Interventions

research subjects:Intraoperative closure of surgical incisions with Prineo skin tissue adhesive
control subjects:Intraoperative closure of surgical incisions with skin staples

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Age 18 to 80 years; 2)Confirmed diagnosis of osteoarthritis (ICD-11 disease code L2-FA0) or osteoarthritis of the knee (ICD-11 disease code FA01); 3) Total knee arthroplasty (TKA) with ICD-9-CM3 procedure code 81.411; 4) Documented as an initial total knee arthroplasty;

Exclusion criteria

Exclusion criteria: 1) Patients receiving TKA for acute reasons, such as fractures or trauma; 2) Patients with known hypersensitivity to cyanoacrylates, formaldehyde, benzalkonium chloride, or pressure-sensitive adhesives may not be included in the study group; 3) Presence of coagulopathy or history of coagulopathy; 4) Concomitant malignancy, severe immune system disease, diabetes mellitus, or peripheral vascular disease; 5) Anticipated surgical incision >20 cm may not be included in the study group; 6) Those deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Delayed healing rate of incisions;Incidence of postoperative infections;Incidence of incision dehiscence;

Secondary

MeasureTime frame
Incidence of contact dermatitis;Incidence of other complications;

Countries

China

Contacts

Public ContactZongke Zhou

West China Hospital, Sichuan University

zongke@126.com+86 189 8060 1028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026