Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping

September 6, 2022 updated by: Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to Phleboextraction Surgery including Saphenectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Edema is a common complication after stripping surgery, so measures that can help the resolution of the condition are important for the recovery in the post operative. The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to phleboextraction surgery including saphenectomy. Therefore, 60 patients of both sexes will be invited to participate in the study, undergoing saphenectomy surgery, divided into two homogeneous groups, determined by the sample calculation. The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in intraoperative period associated with compression with elastic stockings. The control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression by elastic stockings. The procedures for evaluation will be applied before and after seven days of therapeutic intervention. For data analysis, the normality test will be performed and distribution, in addition to a suitable statistical test for the appropriate intra and intergroups, with a significance level of 5%.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • Medical School of Ribeirão Preto

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

25 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy.

Exclusion Criteria:

  • allergies
  • skin lesions
  • ulcers.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
The control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression compression by elastic stockings.
Other: No trasoperative taping
Patients will received only compression stockings after surgery
Experimental: Intervention Group
The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in the period intraoperative associated with compression with elastic stockings.
Procedure: Transoperative taping
The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, on intraoperative period associated with compression with elastic stockings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema
Time Frame: 7 days
Perimetry (cm)
7 days
Dieletric constant
Time Frame: 7 days
MoistureMeterD
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elasticity
Time Frame: 7 days
ElastiMeterD
7 days
Pain after surgery
Time Frame: 7 days
Visual Analogue Scale (VAS)
7 days
Functionality of Lower Limbs
Time Frame: 7 days
Lower Extremity Functional Scale (LEFS)
7 days
Tissue stiffness
Time Frame: 7 days
Elastography
7 days

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Elaine CO Guirro, PhD, University of Sao Paulo

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 (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 20, 2024

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

After the end of Research

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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