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Randomized clinical trial for Fibrin Sealant in knee surgery

Randomized clinical trial for Fibrin Sealant in knee surgery - Fibrin Sealant in knee surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31572
Enrollment
257
Registered
2008-09-05
Start date
2009-08-18
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 replacement

Interventions

Surgery will be performed as usual. Only just before wound closure the fibrin sealant will be spayed over the wound surface.

Sponsors

Sanquin Bloedbank
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •patients who will undergo knee replacement susrgery •Age, minimum of 18 years •Gender, man or woman •Admission of the patient after informed consent

Exclusion criteria

Exclusion criteria: •Liver failure •Congenital or acquired coagulation disorders •Patients who need coumarine derivatives (acenocoumarol or fenprocoumon)

Design outcomes

Primary

MeasureTime frame
total volume of fluid in the drains at 6h post-operative.

Secondary

MeasureTime frame
Secondary endpoints: total volume of fluid in the drains at 24h post-operative, amount of blood transfused, size of the knee, amount of pain and mobility (quality of life) after surgery, length of stay in hospital, adverse events, satisfaction with fibrin sealant as used by the physician.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)