Total Knee Arthroplasty
Conditions
Keywords
Blood loss, Total knee arthroplasty, Adults, Drain, Drainage system
Brief 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.
Detailed description
Secondary's hypothesis: * It don't expect differences in: 1. Incidence of hematomas 2. Incidence in surgery wound infection 3. Time of immobilization 4. Duration of hospitalization * The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)
Interventions
DEVICElow 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).
DEVICEHigh 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
Instituto de Salud Carlos III
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult knee replacement patients who agreed to participate in the study
Exclusion criteria
* People that not accomplished the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total post-surgical blood loss (mL) | from the moment after surgery until drainage catheter removal |
Secondary
| Measure | Time frame |
|---|---|
| Blood loss in the ward | 5-10 days |
| need for a blood transfusion according to the surgeon's criteria | 10 days |
| number of blood units required for transfusion | 10 Days |
| post-surgical pain (using a 100mm visual analogue scale) | 10 days |
| incidence of hematomas | 10 days |
| infections | 10 days |
| blood loss (mL) in the recovery unit | 24-48 h |
| re-intervention due to complications in the surgical wound | 10 dasy |
| venous thrombosis | 10 days |
| hypotension | 10 days |
| mortality | 10 days |
| adverse reactions | 10 days |
| suture dehiscence | 10 days |
Countries
Spain
Outcome results
None listed