Clinical trial NCT06616376: The Affect Of An Anti-Embolism Stocking Protocol
Official title: The Affect Of An Anti-Embolism Stocking Protocol On The Development Of Early Venous Thromboembolia In Patients With Knee Artroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Keywords: Anti-embolism Stockings
Knee Arthroplasty
Nonpharmacological Method
Orthopedic Nursing
Venous Thromboembolism
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Distribution of Descriptive Characteristics and Surgical Information of the Patients
timeFrame: Three weeks
measure: VTE Evaluation Form
timeFrame: Three weeks
Secondary outcomes:
measure: The Use of Anti Embolism Stocking Protocol
timeFrame: Two weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukuruvo University
state: Sarıcam/Adana
Study officials:
affiliation: Ç.Ü Faculty of Health Sciences Department of Surgical Nursing
name: Sevilay ERDEN, Assoc.Prof.
role: STUDY_CHAIR
References: