Evaluation of a New Technique to Fill the Defect Generated After Conservative Surgery in Breast Cancer

NCT04092842 | Completed DMC

• 1 other identifier: IIBSP-SIL-2017-70
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The placement of a small silicone prosthesis in the partial defects generated by conservative breast cancer surgery improves the aesthetic result, compared to the usual surgical technique, in a safe and reproducible way and compatible with adjuvant treatments. It could also potentially improve the quality of life of patients

Conditions

Breast Conserving Surgery

Keywords

Breast Neoplasms; Breast Conserving Surgery

Outcome Measures

Primary Outcomes (1)

• Aesthetic result

  Aesthetic result of the new technique by applying a visual analog scale for measuring patient satisfaction. Scale ranges: minimum score: 0 (no satisfaction - worse outcome), maximum score: 10 (total satisfaction - better outcome)

  4 weeks

Secondary Outcomes (1)

• Surgical complications

  4 weeks

Study Arms (2)

Group intervention: Silicone prothesis

EXPERIMENTAL

Breast cancer conservative surgery will be performed by removing the tumor according to the usual technique and then the defect generated will be filled with a silicone prosthesis of the same size. Said prosthesis will be covered with fat and subcutaneous cellular tissue and then the skin will be closed.

Device: Silicone prosthesis

Group control: Usual surgical technique

ACTIVE COMPARATOR

Breast cancer conservative surgery will be performed according to the usual surgical technique, that is, removing the tumor and covering the defect by mobilizing the breast tissue and then closing the skin.

Procedure: Usual practice

Interventions

Silicone prosthesis DEVICE

Silicone prosthesis

Group intervention: Silicone prothesis

Usual practice PROCEDURE

Usual surgery

Group control: Usual surgical technique

Eligibility Criteria

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

You may qualify if:

• \- Women, over 18 years old, with breast cancer who attend breast pathology consultations at the Sant Pau Hospital in which conservative surgery is indicated.

You may not qualify if:

• Multicentric tumors
• Tumors larger than 5cm
• Locally advanced tumors (T4): Deep plane involvement or skin involvement
• Patients in stages IV (distance dissemination)
• Patients who need mastectomy
• Patients with disabilities or who do not understand the terms of the study or do not agree to participate in the study

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group whith silicone prothesis Group whith standard surgical procedure

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: September 18, 2019
• Primary Completion: July 29, 2021
• Study Completion: March 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

ES (1)