Effectiveness of Compressive Bandage Use in Seroma Prevention

NCT04471142 | Unknown FDA Device

• 1 other identifier: Instituto Nacional do Câncer
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

physiotherapy; seroma; breast cancer; taping

Outcome Measures

Primary Outcomes (3)

• 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

• Seroma volume

  the total volume drained and the number of aspirations will be considered necessary until resolution of the picture.

  30 days

• 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 Outcomes (2)

• Safety of the use of the compressive bandage in mastectomized women

  7 days

• To assess the tolerance reported by the patient to the use of compressive taping

  7 days

Study Arms (2)

Group A

EXPERIMENTAL

Intervention group with preventive application of compressive bandages in addition to suction drain (routine adopted at the institution).

Device: neuromuscular bandage

Group B

NO INTERVENTION

Group control. The patient will follow the institution's routine with only the suction drain.

Interventions

neuromuscular bandage DEVICE

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.

Also known as: compressive taping, compressiva bandage

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 and over
• underwent mastectomy assurgical treatment for breast cancer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

Erica Alves Nogueira Fabro

Rio de Janeiro, 20530-003, Brazil

Location

Related Publications (2)

• Fabro EAN, Costa RM, Fernandes MC, Ximenes MA, Nogueira DA, Soares NB, Thuler LCS, Bergmann A. Seroma incidence and risk factors in women undergoing mastectomies as surgical breast cancer treatment. Support Care Cancer. 2024 Sep 25;32(10):688. doi: 10.1007/s00520-024-08881-w.

  PMID: 39322817 DERIVED

• Fernandes MC, Fabro EAN, Ximenes MA, Costa RMM, Soares NB, Aguiar SS, Thuler LCS, Bergmann A. Compressive taping to prevent postmastectomy seroma: patient adherence and satisfaction. BMJ Support Palliat Care. 2024 May 17:spcare-2024-004912. doi: 10.1136/spcare-2024-004912. Online ahead of print.

  PMID: 38760081 DERIVED

MeSH Terms

Conditions

Seroma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erica Fabro, Master

  INCA - Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Fabro, Master

CONTACT

55 21 993971746; efabro@inca.gov.br

Anke Bergamnn, Doctor

CONTACT

55 21 32076551; abergmann@inca.gov.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: INCA Effectiveness Seroma Prevention

Model Details: All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing, those considered eligible will be randomized to the intervention or control group. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and permanently removed on the seventh day when they will be reevaluated. Group B: control group. Patient will follow the routine of the institution only with the suction drain.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: November 8, 2021
• Primary Completion: June 30, 2022
• Study Completion: March 30, 2023
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

BR (1)