Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Completed; Phase 3

Conditions: Total Knee Arthroplasty

Treatments: Device: High pressure suction drainage; Device: low pressure suction drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT00866268

DRENAJE50MMHG/1

Details and patient eligibility

About

Principal hypothesis:

A low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.

Full description

Secondary's hypothesis:

It don't expect differences in:

Incidence of hematomas Incidence in surgery wound infection Time of immobilization Duration of hospitalization The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult knee replacement patients who agreed to participate in the study

Exclusion criteria

• People that not accomplished the inclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 2 patient groups

Low suction drainage

Experimental group

Description:

In the experimental group the drainage catheter was connected to a modified DRENOFAST® system. This system consisted of a sterile plastic bottle with a holding capacity of 600 mL of fluid and a negative pressure of 700mmHg. It was hermetically closed and had two connections. The DRENOFAST® modification consisted of establishing an open connection between the bottle and a wall vacuum source (normally used to administer oxygen) placed next to the patient's bed. The 50 mmHg constant negative pressure of the bottle was maintained by the wall vacuum source and verified by flow meter.

Treatment:

Device: low pressure suction drainage

High suction drainage

Active Comparator group

Description:

The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg.

Treatment:

Device: High pressure suction drainage