NCT05534308

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

June 9, 2022

Last Update Submit

September 6, 2022

Conditions

Keywords

Functional BandagesEdemaUltrasoundVarices

Outcome Measures

Primary Outcomes (2)

  • Edema

    Perimetry (cm)

    7 days

  • Dieletric constant

    MoistureMeterD

    7 days

Secondary Outcomes (4)

  • Elasticity

    7 days

  • Pain after surgery

    7 days

  • Functionality of Lower Limbs

    7 days

  • Tissue stiffness

    7 days

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Intervention Group

EXPERIMENTAL

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

Interventions

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 Group

Patients will received only compression stockings after surgery

Control Group

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • allergies
  • skin lesions
  • ulcers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School of Ribeirão Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

EdemaVaricose VeinsCone-Rod Dystrophies

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesEye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Elaine CO Guirro, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Central Study Contacts

Elaine CO Guirro, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 9, 2022

First Posted

September 9, 2022

Study Start

October 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 20, 2024

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

After the end of Research

Locations