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Completed

NCT Number: NCT00866268

Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain

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About this study

Secondary's hypothesis:

  • It don't expect differences in:
  • Incidence of hematomas
  • Incidence in surgery wound infection
  • Time of immobilization
  • Duration of hospitalization
  • The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • People that not accomplished the inclusion criteria

Treatment and study plan

low pressure suction drainage

Device

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

High pressure suction drainage

Device

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

Primary outcomes

  1. total post-surgical blood loss (mL)

    Time frame: from the moment after surgery until drainage catheter removal

Secondary outcomes

  1. blood loss (mL) in the recovery unit

    Time frame: 24-48 h

  2. Blood loss in the ward

    Time frame: 5-10 days

  3. need for a blood transfusion according to the surgeon's criteria

    Time frame: 10 days

  4. number of blood units required for transfusion

    Time frame: 10 Days

  5. post-surgical pain (using a 100mm visual analogue scale)

    Time frame: 10 days

  6. incidence of hematomas

    Time frame: 10 days

  7. infections

    Time frame: 10 days

  8. suture dehiscence

    Time frame: 10 days

  9. re-intervention due to complications in the surgical wound

    Time frame: 10 dasy

  10. venous thrombosis

    Time frame: 10 days

  11. hypotension

    Time frame: 10 days

  12. mortality

    Time frame: 10 days

  13. adverse reactions

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 20, 2009
Registry last updated
Mar 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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