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CompletedNCT06616376Updated Sep 27, 2024

The Affect Of An Anti-Embolism Stocking Protocol

An interventional study of Anti-Embolism Stocking in Venous Thromboembolism, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Oct 2019, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

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).

02

Conditions studied

  • Venous Thromboembolism

Keywords

  • Anti-embolism Stockings
  • Knee Arthroplasty
  • Nonpharmacological Method
  • Orthopedic Nursing
  • Venous Thromboembolism
03

In context

Embolism

707 studies on the registry are indexed under Embolism; 74 are open to participants now.

This study's enrollment of 40 is below the median of 129 across 361 interventional studies indexed under Embolism.

Browse Embolism studies →

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Older than 18 years old,
  • No harm in wearing AES,
  • Patients who agreed to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • 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,
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Experimental Group

    AES was redressed within the 21st day after the operation

    Other: Anti-Embolism Stocking

  • No intervention
    Control Group

    The AES was dressed within the 10st day after the operation remained in the patient until the sutures

Interventions

  • OtherAnti-Embolism Stocking

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Three weeks

  2. VTE Evaluation Form

    It consists of 19 questions covering symptoms of VTE, DVT and PE.

    Time frame: Three weeks

Secondary outcomes

  1. The Use of Anti Embolism Stocking Protocol

    It Consısts Of 11 Questıons About The Use Of Antı-Embolısm Socks

    Time frame: Two weeks

07

Study locations

1 site
  • Cukuruvo University
    Adana, Sarıcam/Adana 01330, Turkey
08

References and documents

Study documents

  • Study protocol · Oct 24, 2021
  • Statistical analysis plan · Oct 24, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06616376
Lead sponsor
Cukurova University
Responsible party
Ismail Furkan Basıbuyuk (specialist nurse, Cukurova University) — Principal investigator
First posted
Sep 27, 2024
Start date
Oct 16, 2019
Primary completion
Feb 17, 2021
Completion
Feb 17, 2021
Last update
Sep 27, 2024

Study contacts

Sevilay ERDEN, Assoc.Prof.
study chair · Ç.Ü Faculty of Health Sciences Department of Surgical Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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