Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

"Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty: a Double Blind Randomized Controlled Trial"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866268
• Other study ID #: DRENAJE50MMHG/1
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2009
• Last updated: March 19, 2009
• Start date: May 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2009
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult knee replacement patients who agreed to participate in the study

Exclusion Criteria:

• People that not accomplished the inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya
Spain	Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.	Barcelona	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total post-surgical blood loss (mL)		from the moment after surgery until drainage catheter removal	No
Secondary	blood loss (mL) in the recovery unit		24-48 h	No
Secondary	Blood loss in the ward		5-10 days	No
Secondary	need for a blood transfusion according to the surgeon's criteria		10 days	No
Secondary	number of blood units required for transfusion		10 Days	No
Secondary	post-surgical pain (using a 100mm visual analogue scale)		10 days	No
Secondary	incidence of hematomas		10 days	Yes
Secondary	infections		10 days	Yes
Secondary	suture dehiscence		10 days	Yes
Secondary	re-intervention due to complications in the surgical wound		10 dasy	Yes
Secondary	venous thrombosis		10 days	Yes
Secondary	hypotension		10 days	Yes
Secondary	mortality		10 days	Yes
Secondary	adverse reactions		10 days	Yes