Total Knee ArthroplastyPhase 3NCT00866268
Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty
A Phase 3 study testing low pressure suction drainage and High pressure suction drainage in people with Total Knee Arthroplasty, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- low pressure suction drainage and High pressure suction drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesSpain
- Study dates
- May 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult knee replacement patients who agreed to participate in the study
Who cannot join
- People that not accomplished the inclusion criteria
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08025
Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.
Barcelona, Catalonia, 08025
About this study
Official title: "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.
Read the detailed description
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)
- Conditions
- Total Knee Arthroplasty
- Being tested
- low pressure suction drainage, High pressure suction drainage
- Keywords
- Blood loss, Total knee arthroplasty, Adults, Drain, Drainage system
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low pressure suction drainageDevice
Also called DRENOFAST® modified
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 drainageDevice
Also called DRENOFAST® system
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.
| Study group | Role | What they receive |
|---|---|---|
| Low suction drainage | Experimental | 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. Receives: Device: low pressure suction drainage |
| High suction drainage | Active comparator | The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg. Receives: Device: High pressure suction drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
total post-surgical blood loss (mL)
Measured: from the moment after surgery until drainage catheter removal
Secondary outcomes (13)
blood loss (mL) in the recovery unit
Measured: 24-48 h
Blood loss in the ward
Measured: 5-10 days
need for a blood transfusion according to the surgeon's criteria
Measured: 10 days
number of blood units required for transfusion
Measured: 10 Days
post-surgical pain (using a 100mm visual analogue scale)
Measured: 10 days
incidence of hematomas
Measured: 10 days
infections
Measured: 10 days
suture dehiscence
Measured: 10 days
re-intervention due to complications in the surgical wound
Measured: 10 dasy
venous thrombosis
Measured: 10 days
hypotension
Measured: 10 days
mortality
Measured: 10 days
adverse reactions
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMay 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Investigators
- Calvo Rafael, Rn, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866268
- Sponsor's protocol ID
- DRENAJE50MMHG/1
- Status last verified
- Mar 2009
- First submitted
- 19 Mar 2009
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty: a Double Blind Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT00866268
- Acronym / sponsor ID
- DRENAJE50MMHG/1
- Conditions
- Total Knee Arthroplasty
- Keywords
- Blood loss, Total knee arthroplasty, Adults, Drain, Drainage system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- May 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low suction drainage | Experimental | Device: low pressure suction drainageIn 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 | Active comparator | Device: High pressure suction drainageThe standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult knee replacement patients who agreed to participate in the study
Key exclusion criteria (1 listed)
- People that not accomplished the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low pressure suction drainageAlso: DRENOFAST® modifiedIn 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). | Device | Low suction drainage |
| High pressure suction drainageAlso: DRENOFAST® systemIn 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. | Device | High suction drainage |
Primary outcome
total post-surgical blood loss (mL)
Time frame: from the moment after surgery until drainage catheter removal
13 secondary outcomes
blood loss (mL) in the recovery unit
Time frame: 24-48 h
Blood loss in the ward
Time frame: 5-10 days
need for a blood transfusion according to the surgeon's criteria
Time frame: 10 days
number of blood units required for transfusion
Time frame: 10 Days
post-surgical pain (using a 100mm visual analogue scale)
Time frame: 10 days
incidence of hematomas
Time frame: 10 days
infections
Time frame: 10 days
suture dehiscence
Time frame: 10 days
re-intervention due to complications in the surgical wound
Time frame: 10 dasy
venous thrombosis
Time frame: 10 days
hypotension
Time frame: 10 days
mortality
Time frame: 10 days
adverse reactions
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calvo Rafael, Rn principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing low pressure suction drainage and High pressure suction drainage in people with Total Knee Arthroplasty, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total post-surgical blood loss (mL) (time frame: from the moment after surgery until drainage catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2009.