Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

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.

Trial Locations (2)

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau., Barcelona

All Listed Sponsors
collaborator

Instituto de Salud Carlos III

OTHER_GOV

lead

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

OTHER

NCT00866268 - Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty | Biotech Hunter | Biotech Hunter