Venous ThromboembolismNCT06616376
The Affect Of An Anti-Embolism Stocking Protocol
A study testing Anti-Embolism Stocking in people with Venous Thromboembolism, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of anti-embolism stocking (AES) use protocol affected the development of early venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Anti-Embolism Stocking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2019to 17 Feb 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years old,
- No harm in wearing AES,
- Patients who agreed to participate in the study.
Who cannot join
- Bilateral TKA used patients,
- Having excess leg edema, pulmonary edema, heart failure,
- Having leg ischemia,
- Having skin graft,
- An open wound in the area where AES will be applied,
- Having arterial and venous vessel disease,
Show all 10Show fewer
- Having neuropathy,
- Having cellulite on the patient's leg to whom AES will be applied,
- Having an infection such as fasciitis or panniculitis,
- Those who declare that they will not use AES for ten days in accordance with the recommendations.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukuruvo University
Adana, Sarıcam/Adana, 01330
About this study
Official title: The Affect Of An Anti-Embolism Stocking Protocol On The Development Of Early Venous Thromboembolia In Patients With Knee Artroplasty
This study was conducted to determine the effect of anti-embolism stocking (AES) use protocol affected the development of early venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA).
The randomized controlled single-blind intervention study included 40 patients (Experimental Group: 20, Control Group: 20) who underwent TKA surgery in a university hospital's Orthopedics and Traumatology clinic between 2019 and 2021. While the experimental group received the AES protocol one day before the operation and continued until the 10 th day after the operation, the control group received AES on the 0 th day after the operation and remained in the patient until the 21st day after the operation. In the study, a "Data Collection Form" with DVT and PE signs and symptoms was used.
Read the detailed description
The study was carried out at a university hospital's Orthopedics and Traumatology clinic. Knee arthroplasty surgery is performed on an average of 85 patients per year in the hospital with a bed capacity of 1200. The Orthopedics and Traumatology clinic has 36 beds and 9 nurses on staff.
In the clinic, LMWH is given to patients who will have knee arthroplasty 12 hours before the procedure. Following knee arthroplasty, an elastic bandage is placed over the dressing on the operated extremity, and AES is only applied to the intact extremity. AES is dressed on both extremities after the elastic bandage is removed. Foot movements begin on the first postoperative day, and patients are mobilized on the first or second postoperative day. Patients are admitted to the clinic for a period of 5-7 days. LMWH application, which began in the preoperative period, continues in the postoperative period for approximately 21 days (until the sutures are removed). The AES usage protocol is not implemented in the clinic, and no training is provided to patients regarding the use of AES by healthcare personnel. After TKA surgery, AES patients are dressed, and it is recommended that they wear them without removing them for 21 days (sutures are removed).
- Conditions
- Venous Thromboembolism
- Being tested
- Anti-Embolism Stocking
- Keywords
- Anti-embolism Stockings, Knee Arthroplasty, Nonpharmacological Method, Orthopedic Nursing, Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Embolism StockingOther
To prevent patients undergoing TKA surgery from being affected by one another, the patients were hospitalized in separate rooms, and the orthopedic clinic team was made aware of the situation. The patients in the control group were told not to remove their socks until the sutures were removed after the operation, whereas the patients in the experimental group were told to remove their socks on the 10th day after the operation, so the patients had no idea which group they were in.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | AES was redressed within the 21st day after the operation Receives: Other: Anti-Embolism Stocking |
| Control Group | No intervention | The AES was dressed within the 10st day after the operation remained in the patient until the sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Descriptive Characteristics and Surgical Information of the Patients
The mean age of the experimental group was 68.6±7.1 years (range: 51-81 years) and the mean age of the control group was 68.5±8.8 years (range: 57-89 years). There was chronic disease in 90% of the experimental group, and the rate of chronic disease in the control group was 60%. Mobility status of the experimental group 1 day before the surgery; 65% (n:13) were independent, 15% (n:3) self-supported and 20% (n:4) needed help. Mobility status of the control group 1 day before the surgery; 60% (n:11) were independent, 40% (n:8) self-supported, and 5% (n:1) needed help. Mobility status of the experimental group after surgery; 10% (n:2) were independent, 90% (n:18) were self-sufficient. Mobility status in the control group; 20% (n:4) were independent, 75% (n:15) were self-sufficient and 5% (n:1) needed help. All patients in the experimental and control groups used low molecular weight heparin or anticoagulants before surgery.
Measured: Three weeks
VTE Evaluation Form
It consists of 19 questions covering symptoms of VTE, DVT and PE.
Measured: Three weeks
Secondary outcomes (1)
The Use of Anti Embolism Stocking Protocol
It Consısts Of 11 Questıons About The Use Of Antı-Embolısm Socks
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start16 Oct 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted as a randomized controlled single-blind intervention study to determine the effect of the AES use protocol on the development of early VTE in patients undergoing knee arthroplasty.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Furkan Basıbuyuk, Cukurova University
- Investigators
- Sevilay ERDEN, Assoc.Prof., Study chair, Ç.Ü Faculty of Health Sciences Department of Surgical Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616376
- Sponsor's protocol ID
- CukurovaUBasibüyükErden
- Status last verified
- Sep 2024
- First submitted
- 16 Nov 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect Of An Anti-Embolism Stocking Protocol On The Development Of Early Venous Thromboembolia In Patients With Knee Artroplasty
- ClinicalTrials.gov ID
- NCT06616376
- Acronym / sponsor ID
- CukurovaUBasibüyükErden
- Conditions
- Venous Thromboembolism
- Keywords
- Anti-embolism Stockings, Knee Arthroplasty, Nonpharmacological Method, Orthopedic Nursing, Venous Thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 27 Sep 2024 (actual)
- 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.
This study was conducted to determine the effect of anti-embolism stocking (AES) use protocol affected the development of early venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA).
The randomized controlled single-blind intervention study included 40 patients (Experimental Group: 20, Control Group: 20) who underwent TKA surgery in a university hospital's Orthopedics and Traumatology clinic between 2019 and 2021. While the experimental group received the AES protocol one day before the operation and continued until the 10 th day after the operation, the control group received AES on the 0 th day after the operation and remained in the patient until the 21st day after the operation. In the study, a "Data Collection Form" with DVT and PE signs and symptoms was used.
Detailed description
The study was carried out at a university hospital's Orthopedics and Traumatology clinic. Knee arthroplasty surgery is performed on an average of 85 patients per year in the hospital with a bed capacity of 1200. The Orthopedics and Traumatology clinic has 36 beds and 9 nurses on staff.
In the clinic, LMWH is given to patients who will have knee arthroplasty 12 hours before the procedure. Following knee arthroplasty, an elastic bandage is placed over the dressing on the operated extremity, and AES is only applied to the intact extremity. AES is dressed on both extremities after the elastic bandage is removed. Foot movements begin on the first postoperative day, and patients are mobilized on the first or second postoperative day. Patients are admitted to the clinic for a period of 5-7 days. LMWH application, which began in the preoperative period, continues in the postoperative period for approximately 21 days (until the sutures are removed). The AES usage protocol is not implemented in the clinic, and no training is provided to patients regarding the use of AES by healthcare personnel. After TKA surgery, AES patients are dressed, and it is recommended that they wear them without removing them for 21 days (sutures are removed).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was conducted as a randomized controlled single-blind intervention study to determine the effect of the AES use protocol on the development of early VTE in patients undergoing knee arthroplasty.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Anti-Embolism StockingAES was redressed within the 21st day after the operation |
| Control Group | No intervention | –The AES was dressed within the 10st day after the operation remained in the patient until the sutures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years old,
- No harm in wearing AES,
- Patients who agreed to participate in the study.
Key exclusion criteria (10 listed)
- Bilateral TKA used patients,
- Having excess leg edema, pulmonary edema, heart failure,
- Having leg ischemia,
- Having skin graft,
- An open wound in the area where AES will be applied,
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 |
|---|---|---|
| Anti-Embolism StockingTo prevent patients undergoing TKA surgery from being affected by one another, the patients were hospitalized in separate rooms, and the orthopedic clinic team was made aware of the situation. The patients in the control group were told not to remove their socks until the sutures were removed after the operation, whereas the patients in the experimental group were told to remove their socks on the 10th day after the operation, so the patients had no idea which group they were in. | Other | Experimental Group |
Primary outcome
Distribution of Descriptive Characteristics and Surgical Information of the Patients
Time frame: Three weeks
The mean age of the experimental group was 68.6±7.1 years (range: 51-81 years) and the mean age of the control group was 68.5±8.8 years (range: 57-89 years). There was chronic disease in 90% of the experimental group, and the rate of chronic disease in the control group was 60%. Mobility status of the experimental group 1 day before the surgery; 65% (n:13) were independent, 15% (n:3) self-supported and 20% (n:4) needed help. Mobility status of the control group 1 day before the surgery; 60% (n:11) were independent, 40% (n:8) self-supported, and 5% (n:1) needed help. Mobility status of the experimental group after surgery; 10% (n:2) were independent, 90% (n:18) were self-sufficient. Mobility status in the control group; 20% (n:4) were independent, 75% (n:15) were self-sufficient and 5% (n:1) needed help. All patients in the experimental and control groups used low molecular weight heparin or anticoagulants before surgery.
VTE Evaluation Form
Time frame: Three weeks
It consists of 19 questions covering symptoms of VTE, DVT and PE.
1 secondary outcome
The Use of Anti Embolism Stocking Protocol
Time frame: Two weeks
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 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Sevilay ERDEN, Assoc.Prof. study chair
Ç.Ü Faculty of Health Sciences Department of Surgical Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Embolism Stocking in people with Venous Thromboembolism, run by Cukurova University at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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.
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?
Distribution of Descriptive Characteristics and Surgical Information of the Patients (time frame: Three weeks). The study lists 2 primary outcomes in all. 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 27 Sep 2024.