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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00866268
Other study ID # DRENAJE50MMHG/1
Secondary ID
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


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
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