Randomized Assessor-Masked Trial of Moderate Graduated Compression Stockings for Popliteal Vein Dilation During Long-Haul Economy-Class Air Travel After Aesthetic Surgery

September 2, 2026 updated by: Research Inc
This randomized assessor-masked trial will evaluate whether knee-high moderate graduated compression stockings reduce popliteal vein dilation during long-haul economy-class air travel to Bogota. Participants will be assigned to stockings or no stockings and will undergo bilateral ultrasound before flight, within 2 hours after arrival, and at 24 and 48 hours. The primary outcome is the between-group difference in change in mean bilateral popliteal vein diameter from preflight baseline to arrival.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible economy-class travelers will be randomized before departure. The intervention group will wear properly fitted knee-high graduated compression stockings from approximately 1 hour before boarding through the arrival ultrasound; the control group will not use lower-limb compression. A masked ultrasound assessor will obtain standardized bilateral diameter and cross-sectional-area measurements before flight and at arrival, 24 hours, and 48 hours. Adherence, movement, hydration, symptoms, and skin effects will be recorded. Intention-to-treat mixed models will estimate immediate and persistent treatment effects.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 to 65 years.
  • Economy-class commercial itinerary to Bogota with at least 4 hours of total airborne time.
  • No clinical indication that mandates or prohibits compression stockings.
  • Ability to obtain the assigned stocking before boarding and wear it as instructed.
  • Standardized preflight and postarrival ultrasounds completed before surgery.
  • Written informed consent.

Exclusion Criteria:

  • Current deep venous thrombosis, therapeutic anticoagulation, or severe peripheral arterial disease.
  • Significant lower-limb skin disease, ulceration, neuropathy, or deformity preventing safe stocking use.
  • Pregnancy.
  • Planned use of another compression device during the flight.
  • Surgery or major intravenous fluid therapy before completion of the 48-hour examination.
  • Inability to complete preflight ultrasound or follow assigned treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate Compression Stockings
Participants wear properly fitted knee-high graduated compression stockings during the qualifying flight, beginning approximately 1 hour before boarding and removing them after the arrival ultrasound. all patients got enoxaparin to prevent blood clots
Drug: Enoxaparine
All patients got enoxaparin to prevent blood clots
Device: Knee-High Graduated Compression Stockings
PROPOSED pressure class: 20-30 mmHg at the ankle, appropriately sized according to calf and ankle circumference, worn from approximately 1 hour before boarding until completion of the arrival ultrasound. The final product, pressure class, fitting method, and wear instructions must be confirmed. Linked arm/group(s): Moderate Compression Stockings.
Diagnostic test: Standardized Bilateral Popliteal Vein Ultrasound
Triplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation. Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings.
Active Comparator: No Compression Stockings
Participants do not wear compression stockings or another lower-limb compression device during the qualifying flight. All patients got enoxaparin to prevent blood clots
Drug: Enoxaparine
All patients got enoxaparin to prevent blood clots
Diagnostic test: Standardized Bilateral Popliteal Vein Ultrasound
Triplicate bilateral diameter and cross-sectional-area measurements after a standardized rest period, with compressibility and flow assessment by an assessor masked to allocation. Linked arm/group(s): Moderate Compression Stockings, No Compression Stockings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Change in Mean Bilateral Popliteal Vein Diameter
Time Frame: Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days
Between-group difference in baseline-to-arrival change in the mean of triplicate anteroposterior diameter measurements from both legs, reported in millimeters and percent change.
Within 24 hours before departure and within 2 hours after arrival at the study site. 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Stocking-Related Adverse Effects
Time Frame: From stocking application through 24 hours after arrival. 5 days
Proportion with skin injury, numbness, clinically significant pain, intolerance, or early removal attributed to the stocking.
From stocking application through 24 hours after arrival. 5 days
Incidental Venous Thrombosis or Abnormal Compressibility
Time Frame: From preflight baseline through 48 hours after arrival - 1 week
Number and proportion with an ultrasound abnormality requiring urgent clinical assessment.
From preflight baseline through 48 hours after arrival - 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Inc

Investigators

  • Principal Investigator: Hugo Aguilar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 9, 2026

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017 (Other Identifier: Nahrain Medical Research Collective (NMRC))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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