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

Primary Purpose

Edema, Varices; Cord

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transoperative taping
No trasoperative taping
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edema focused on measuring Functional Bandages, Edema, Ultrasound, Varices

Eligibility Criteria

25 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • allergies
  • skin lesions
  • ulcers.

Sites / Locations

  • Medical School of Ribeirão Preto

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Edema
Perimetry (cm)
Dieletric constant
MoistureMeterD

Secondary Outcome Measures

Elasticity
ElastiMeterD
Pain after surgery
Visual Analogue Scale (VAS)
Functionality of Lower Limbs
Lower Extremity Functional Scale (LEFS)
Tissue stiffness
Elastography

Full Information

First Posted
June 9, 2022
Last Updated
September 6, 2022
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05534308
Brief Title
Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping
Official Title
Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Varices; Cord
Keywords
Functional Bandages, Edema, Ultrasound, Varices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transoperative taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No trasoperative taping
Intervention Description
Patients will received only compression stockings after surgery
Primary Outcome Measure Information:
Title
Edema
Description
Perimetry (cm)
Time Frame
7 days
Title
Dieletric constant
Description
MoistureMeterD
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Elasticity
Description
ElastiMeterD
Time Frame
7 days
Title
Pain after surgery
Description
Visual Analogue Scale (VAS)
Time Frame
7 days
Title
Functionality of Lower Limbs
Description
Lower Extremity Functional Scale (LEFS)
Time Frame
7 days
Title
Tissue stiffness
Description
Elastography
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy. Exclusion Criteria: allergies skin lesions ulcers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine CO Guirro, PhD
Phone
(16) 3315-4584
Ext
4413
Email
ecguirro@fmrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine CO Guirro, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Medical School of Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After the end of Research
Citations:
PubMed Identifier
32667383
Citation
Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.
Results Reference
result

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

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