Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

F

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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