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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
169
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).
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.
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.
Barcelona, Catalonia, Spain
total post-surgical blood loss (mL)
Time frame: from the moment after surgery until drainage catheter removal
blood loss (mL) in the recovery unit
Time frame: 24-48 h
Blood loss in the ward
Time frame: 5-10 days
need for a blood transfusion according to the surgeon's criteria
Time frame: 10 days
number of blood units required for transfusion
Time frame: 10 Days
post-surgical pain (using a 100mm visual analogue scale)
Time frame: 10 days
incidence of hematomas
Time frame: 10 days
infections
Time frame: 10 days
suture dehiscence
Time frame: 10 days
re-intervention due to complications in the surgical wound
Time frame: 10 dasy
venous thrombosis
Time frame: 10 days
hypotension
Time frame: 10 days
mortality
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 10 days
adverse reactions
Time frame: 10 days