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Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

NCT00866268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2009-03-20

No results posted yet for this study

Summary

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.

Conditions

  • Total Knee Arthroplasty

Interventions

DEVICE

low pressure suction drainage

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. Duration: Drains were removed after bleeding had ceased (48-72h).

DEVICE

High pressure suction drainage

In order to mask the type of intervention from the patient and the investigators, both drainage systems had two drain catheters. One catheter allowed the blood to flow from the wound to the bottle. The second catheter connected the bottle to the vacuum source. In the experimental arm the second catheter was open, while in the control group it was closed. So that the system used could not be distinguished, the connection of the second catheter to the bottle was covered with opaque adhesive tape.Drains were removed after bleeding had ceased.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

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

    lead OTHER

Principal Investigators

  • Calvo Rafael, Rn · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00866268 on ClinicalTrials.gov