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LEAK study

LEAK-study LEakage After primary Knee and hip arthroplasty; finding the best way to treat wound leakage after primary arthroplasty A prospective nationwide multicenter randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26417
Enrollment
388
Registered
2016-07-08
Start date
2017-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

totale knie arthroplastiek, totale heup arthroplastiek, wond lekkage, prothese infectie, revisie chirurgie voor infectie. total knee arthroplasty

Interventions

non-surgical and surgical treatment of persistent wound leakage

Sponsors

UMCG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 or older who have undergone a TKA/THA and experience persistent wound leakage at day 9.

Exclusion criteria

Exclusion criteria: - Mental or physical disability to fulfill study requirements. - Insufficient command of the Dutch language.

Design outcomes

Primary

MeasureTime frame
What is the effectiveness of early intervention (DAIR day 10) versus usual care (nonsurgical treatment) in patients with persistent wound leakage? Primary endpoint will be revision surgery for PJI up to one year.

Secondary

MeasureTime frame
What is the cost effectiveness and cost utility of early intervention (DAIR day 10) versus usual care (nonsurgical treatment) in patients with persistent wound leakage? Primary endpoint will be revision surgery for PJI up to one year. What is the impact of early intervention (DAIR day 10) compared to usual care (nonsurgical treatment) on disease-specific and general health-related quality of life at one year?

Contacts

Public ContactP.C. Jutte

UMCG

E: p.c.jutte@umcg.nlT: 0503612802 |

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)