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

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534308
• Other study ID #: 12241
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: September 2022
• Source: University of Sao Paulo
• Contact: Elaine CO Guirro, PhD
• Phone: (16) 3315-4584
• Email: ecguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 20, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 59 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• allergies

• skin lesions

• ulcers.

Related Conditions & MeSH terms

• Edema
• Varices; Cord

Intervention

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.

Other:
• No trasoperative taping
Patients will received only compression stockings after surgery

Locations

Country	Name	City	State
Brazil	Medical School of Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema	Perimetry (cm)	7 days
Primary	Dieletric constant	MoistureMeterD	7 days
Secondary	Elasticity	ElastiMeterD	7 days
Secondary	Pain after surgery	Visual Analogue Scale (VAS)	7 days
Secondary	Functionality of Lower Limbs	Lower Extremity Functional Scale (LEFS)	7 days
Secondary	Tissue stiffness	Elastography	7 days