LEakage After primary Knee and hip arthroplasty; a randomized controlled study for finding the best way to treat wound leakage after primary arthroplasty

LEakage After primary Knee and hip arthroplasty; a randomized controlled study for finding the best way to treat wound leakage after primary arthroplasty - LEAK study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43183

Enrollment

388

Registered

2016-10-28

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

Postoperative woundleakage/ woundleakage

Interventions

INTERVENTION: Nonsurgical treatment: bed rest, wound care, stop exercise, pressure bandage. Surgical treatment: DAIR on day 10, surgical cleaning of wound and prosthesis, cultures and anitbiotics.

DAIR

Total hip arthroplasty

Total knee arthroplasty

Woundleakage

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older with persistent wound leakage at day 9 after TKA/THA.

Exclusion criteria

Exclusion criteria: - Mental disability to fulfill study requirements (e.g dementia). - Insufficient command of the Dutch language.

Design outcomes

Primary

Measure	Time frame
Primary outcome: reduction in revision surgeries for PJI	—

Secondary

Measure	Time frame
Cost-effectiveness analysis (costs per prevented revision surgery for PJI), cost-utility analysis from a societal perspective (costs per QALY) and a probabilistic Budget Impact Analysis will be conducted.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)