The Affect Of An Anti-Embolism Stocking Protocol

NCT06616376 | Completed

• 1 other identifier: CukurovaUBasibüyükErden
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Three weeks

• VTE Evaluation Form

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

  Three weeks

Secondary Outcomes (1)

• The Use of Anti Embolism Stocking Protocol

  Two weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

AES was redressed within the 21st day after the operation

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

Interventions

Anti-Embolism Stocking OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukuruvo University

Adana, Sarıcam/Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sevilay ERDEN, Assoc.Prof.

  Ç.Ü Faculty of Health Sciences Department of Surgical Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist nurse

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: September 27, 2024
• Study Start: October 16, 2019
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)