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Clinical efficacy and safety of temperature sensitive antiadhesive agent

Clinical efficacy and safety of temperature sensitive antiadhesive agent for preventing antiadhesion after total knee arthroplasty(Prospective, single center, randomized single blind investor initiated trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002185
Enrollment
60
Registered
2016-12-30
Start date
2016-06-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Medical Device : In the experimental group, 3cc of the anti-adhesive agent will be applied to around the operative site before suturing the skin. In control group, the anti-adhesive agent will not be

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who agree with participate in studies 2) Age : 50 - 79 years 3) Patients who was no significant unusual findings in preoperative evaluation 4) Patients who will be taken total knee arthroplasy by primary osteoarthritis of the knee

Exclusion criteria

Exclusion criteria: 1) Patients who participated other studies that medicated drug or treated by medical device 1 month before register this study 2) Previous operative history of ipsilateral knee 3) Patients who will be treated by anti-platelet agent or general steroid within 1 weeks after total knee arthroplasty 4) Patients who diagnosed immunosuppressive disease or autoimmune disease 5) Patients who have allergy on anti-adhesive agent we used 6) Patients who have general infection or infection around the knee joint 7) Patients who diagnosed severe diseases that may affect the operation(for example, heart failure, kidney failure, liver failure, uncontrolled blood pressure, uncontrolled DM, uncontrolled anticoagulation disease) 8) Patients who will take banned medicines in combination during clinical trial 9) Patients who addicted alcohol or medicine, and patients who had psychiatric illness 10) Patients who had history of Parkinson disease, sequelae of poliomyelitis, stroke 11) Patients who had high risk of surgery due to accompanying cardiopulmonary diseases and general disease 12) Patients who require bone graft, block, or long stem due to severe articular destruction and deformity 13) Patients who had difficulty participating clinical trial by judge of the director of clinical trial 14) Pregnant woman or lactating woman

Design outcomes

Primary

MeasureTime frame
knee range of motion

Secondary

MeasureTime frame
skin fold of operation site;Visual analogue Score;Check the adhesion of operation site by ultrasonography;the amount of blood loss, blood transfusion;the amount of analgesics and Patient Controlled Analgesics

Countries

Korea, Republic of

Contacts

Public ContactYoon-Ho Kwak

Seoul National University Hospital

inkwak86@hanmail.net+82-2-2072-3792

Outcome results

None listed

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