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

Sponsor
University of Sao Paulo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534308
Collaborator
(none)
60
1
2
26.6
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transoperative taping
  • Other: No trasoperative taping
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Edema [7 days]

    Perimetry (cm)

  2. Dieletric constant [7 days]

    MoistureMeterD

Secondary Outcome Measures

  1. Elasticity [7 days]

    ElastiMeterD

  2. Pain after surgery [7 days]

    Visual Analogue Scale (VAS)

  3. Functionality of Lower Limbs [7 days]

    Lower Extremity Functional Scale (LEFS)

  4. Tissue stiffness [7 days]

    Elastography

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy.
Exclusion Criteria:
  • allergies

  • skin lesions

  • ulcers.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical School of Ribeirão Preto Ribeirão Preto São Paulo Brazil 14049-900

Sponsors and Collaborators

  • University of Sao Paulo

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elaine Caldeira de Oliveira Guirro, Clinical professor, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT05534308
Other Study ID Numbers:
  • 12241
First Posted:
Sep 9, 2022
Last Update Posted:
Sep 9, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Elaine Caldeira de Oliveira Guirro, Clinical professor, University of Sao Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2022