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Effectiveness of Compressive Bandage Use in Seroma Prevention

NCT04471142 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-09-21

No results posted yet for this study

Summary

INTRODUCTION: Seroma is the most common complication after surgical treatment for breast cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The therapeutic bandage has been inserted in clinical practice because it is similar to the elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain and local swelling, and may have benefits for prevention and treatment of seroma when applied compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and control groups by lot (270 envelopes, 135 patients per group). The intervention group, in addition to the use of the drain, will be submitted to the compression bandage on the day of hospital discharge and will be reevaluated on the seventh day. The control group will follow the institutional routine, using only the drain. The incidence and volume of the seroma, as well as the length of stay of the drain will be evaluated after 30 days through the medical record. Symptoms and skin changes resulting from the use of the bandage will be evaluated through a specific form. ANALYSIS: Descriptive analysis will be by measures of central tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds ratio (for categorical variables) and by mean difference (Student's t-test), considering a 95% confidence interval. To control the confounding variables, multiple logistic regression (categorical outcome) and multiple linear regression (continuous outcome) will be performed by the Stepwise Forward method, including variables with p \<0.20.

Conditions

  • Seroma

Interventions

DEVICE

neuromuscular bandage

After the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape® neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics.

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Principal Investigators

  • Erica Fabro, Master · INCA - Brazil

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-06-30
Completion
2023-03-30
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04471142 on ClinicalTrials.gov