Seroma Clinical Trial
Official title:
Effectiveness of Compressive Bandage Use in Post-Treatment Seroma Prevention Breast Cancer Surgery
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.
Status | Not yet recruiting |
Enrollment | 270 |
Est. completion date | March 30, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women aged 18 and over - underwent mastectomy assurgical treatment for breast cancer. Exclusion Criteria: - bilateral breast cancer; - patient undergoing neoadjuvant radiotherapy; - infection in the surgical wound or hematoma; - autoimmune disease reporting (dermatomyositis, hidradenitis suppurativa, nephropathy, lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma); - patients with difficulties in understanding. |
Country | Name | City | State |
---|---|---|---|
Brazil | Erica Alves Nogueira Fabro | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Cancer, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroma Incidence | the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained. | 30 days | |
Primary | Seroma volume | the total volume drained and the number of aspirations will be considered necessary until resolution of the picture. | 30 days | |
Primary | Permanence time with the Suction Drain | The permanence time (in days) will be checked with the suction drain, as reported by the dressing team. | 15 days | |
Secondary | Safety of the use of the compressive bandage in mastectomized women | The dermal changes will be evaluated at the location of the bandage application of the 135 participants in the intervention group, such as discoloration, increased local temperature, skin peeling, presence of a wound and formation of bullous lesions at the site of the application of the neuromuscular bandage, graded in light, moderate or severe, according to the severity of the change, from a semi-structured questionnaire. | 7 days | |
Secondary | To assess the tolerance reported by the patient to the use of compressive taping | The symptoms of pain, itching, burning, discomfort, tightness, increased fluctuation of the seroma at the site of application of the bandage of the 135 participants will be evaluated. The symptoms will be graded according to the Visual Numeric Scale (0-10), where 0 will be considered no sensation and 10 unbearable sensation with the use of the bandage. | 7 days |
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