Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: low pressure suction drainage; Device: High pressure suction drainage

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 Type: Interventional
• Enrollment (Actual): 169
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• People that not accomplished the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: DRENOFAST® system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total post-surgical blood loss (mL)	from the moment after surgery until drainage catheter removal

Secondary Outcome Measures

Outcome Measure	Time Frame
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
number of blood units required for transfusion	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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 19, 2009
• First Posted (Estimate): March 20, 2009

Study Record Updates

• Last Update Posted (Estimate): March 20, 2009
• Last Update Submitted That Met QC Criteria: March 19, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Adults; Total knee arthroplasty; Blood loss; Drain; Drainage system
• Other Study ID Numbers: DRENAJE50MMHG/1