Adrenaline Reduces Ecchymoses and Hematomas and Improves Quality of Life After Classic Saphenous Vein Stripping

NCT04758728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-02-18

No results posted yet for this study

Summary

Aim of the present study is to investigate the efficiency of adrenaline (epinephrine) used locally in reducing and avoiding post-operative formation of subcutaneous ecchymoses and hematomas, in comparison with traditional practice of hemostasis, and to assess improvement in the quality of life of subjects undergoing classic great saphenous vein stripping, who received or did not receive adrenaline as a local hemostatic.

Conditions

  • Venous Insufficiency (Chronic)(Peripheral)
  • Venous Reflux
  • Venous Insufficiency of Leg
  • Venous Stasis
  • Venous Disease
  • Subcutaneous Haematoma
  • Ecchymosis
  • Bruising

Interventions

PROCEDURE

Great saphenous vein stripping and varicectomies

Removal of the great saphenous vein (partially - from just below the knee up to the saphenofemoral junction) by two 3cm skin and subcutaneous fat incisions and the introduction of a conventional vein stripper device, under general or epidural/regional anesthesia. Removal of varicose veins of the lower limb by 0,5cm skin incisions and the use of a conventional phlebectomy stainless steel hook. Mechanical hemostasis by direct compression of the thigh for 10 minutes.

DRUG

Epinephrine Topical

Use of epinephrine/adrenaline solution 1:1000 topically

DRUG

normal saline

Use of normal saline solution NaCl 0,9% topically

Sponsors & Collaborators

  • General Hospital of Rhodes Andreas Papandreou

    collaborator OTHER_GOV
  • Hellenic Red Cross Hospital

    collaborator OTHER
  • Junior Doctors Network-Hellas

    lead OTHER

Principal Investigators

  • Konstantinos Roditis, MD, MSc · JDN-Hellas / Department of Vascular Surgery, Hellenic Red Cross Hospital

  • Dimitrios Mavros, MD, MSc, PhD · Department of Vascular Surgery, Andreas Papandreou General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-10
Primary Completion
2016-05-14
Completion
2016-06-10

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04758728 on ClinicalTrials.gov