Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty - Full Text View

Purpose

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.

Condition	Intervention	Phase
Total Knee Arthroplasty	Device: low pressure suction drainage Device: High pressure suction drainage	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	"Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty: a Double Blind Randomized Controlled Trial"

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:

total post-surgical blood loss (mL) [ Time Frame: from the moment after surgery until drainage catheter removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood loss (mL) in the recovery unit [ Time Frame: 24-48 h ] [ Designated as safety issue: No ]
Blood loss in the ward [ Time Frame: 5-10 days ] [ Designated as safety issue: No ]
need for a blood transfusion according to the surgeon's criteria [ Time Frame: 10 days ] [ Designated as safety issue: No ]
number of blood units required for transfusion [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
post-surgical pain (using a 100mm visual analogue scale) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
incidence of hematomas [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
infections [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
suture dehiscence [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
re-intervention due to complications in the surgical wound [ Time Frame: 10 dasy ] [ Designated as safety issue: Yes ]
venous thrombosis [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
hypotension [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
mortality [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
adverse reactions [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Enrollment:	169
Study Start Date:	May 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Low 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.	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). Other Name: DRENOFAST® modified
Active Comparator: High suction drainage The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg.	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. Other Name: DRENOFAST® system

Arms

Assigned Interventions

Experimental: Low 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.

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).

Other Name: DRENOFAST® modified

Active Comparator: High suction drainage

The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg.

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.

Other Name: DRENOFAST® system

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult knee replacement patients who agreed to participate in the study

Exclusion Criteria:

People that not accomplished the inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866268

Locations

Spain
Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.
Barcelona, Catalunya, Spain, 08025
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya, Spain, 08025

Sponsors and Collaborators

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

Instituto de Salud Carlos III

Investigators

Principal Investigator:

Calvo Rafael, Rn

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

More Information

No publications provided

Responsible Party:	Rafa Calvo Oyón, Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:	NCT00866268 History of Changes
Other Study ID Numbers:	DRENAJE50MMHG/1
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Blood loss
Total knee arthroplasty
Adults
Drain
Drainage system

ClinicalTrials.gov processed this record on May 23, 2013