Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

Phase 3

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Device: low pressure suction drainage; Device: High pressure suction drainage

• Registration Number: NCT00866268
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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)

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-19
• Last Update Submitted: 2009-03-19
• Study First Posted: 2009-03-20
• Last Update Posted: 2009-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

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

Exclusion Criteria

• People that not accomplished the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low suction drainage	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.
High suction drainage	High pressure suction drainage	The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg.

Primary Outcome Measures

Name	Time	Method
total post-surgical blood loss (mL)	from the moment after surgery until drainage catheter removal

Secondary Outcome Measures

Name	Time	Method
number of blood units required for transfusion	10 Days
blood loss (mL) in the recovery unit	24-48 h
Blood loss in the ward	5-10 days
need for a blood transfusion according to the surgeon's criteria	10 days
post-surgical pain (using a 100mm visual analogue scale)	10 days
incidence of hematomas	10 days
infections	10 days
suture dehiscence	10 days
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

Trial Locations

Locations (2)

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

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalunya, Spain