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Sequential Compression Devices Effect on Fibrinolysis in Plastic Surgery Outpatients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821597
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Swanson Center

Brief Summary:
This study investigates a possible fibrinolytic effect of sequential compression devices (SCDs). These devices have been used for decades to reduce risk of deep venous thrombosis (DVT). However, a randomized study in plastic surgery outpatients has not been done. This study is undertaken to remedy that deficiency in our knowledge base.

Condition or disease Intervention/treatment Phase
Blood Coagulation Disorder Procedure: Sequential compression devices (SCDs) Procedure: No sequential compression. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled study.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Intraoperative Sequential Compression Devices on Fibrinolysis in Plastic Surgery Outpatients: A Randomized Trial
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : January 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequential compression devices
Sequential compression devices (SCDs) are applied during surgery.
Procedure: Sequential compression devices (SCDs)
Application of sequential compression devices in surgery.

Active Comparator: No sequential compression devices
No sequential compression devices are applied.
Procedure: No sequential compression.
No sequential compression devices are applied.




Primary Outcome Measures :
  1. Change in plasma levels of tissue plasminogen activator and plasminogen activator inhibitor-1 [ Time Frame: 1-2 months ]
    Laboratory testing of serum levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All healthy patients aged 18 or more.

Exclusion Criteria:

  • These conditions include suspected active or untreated DVT, pulmonary edema, congestive heart failure, thrombophlebitis or an active infection, vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg, neuropathy, legs that are insensitive to pain, or when increased venous or lymphatic return is undesirable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821597


Locations
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United States, Kansas
Swanson Center
Leawood, Kansas, United States, 66211
Sponsors and Collaborators
Swanson Center
Investigators
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Principal Investigator: Eric Swanson, M.D. Swanson Cener
Publications:
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Responsible Party: Swanson Center
ClinicalTrials.gov Identifier: NCT03821597    
Other Study ID Numbers: Swanson 010
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swanson Center:
Fibrinolysis, sequential compression devices
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders