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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Conserving Surgery
• Intervention / Treatment: Device: Silicone prosthesis; Procedure: Usual practice

Detailed Description

Conservative surgery in breast cancer is performed more than 50% of cases, however, aesthetic results are suboptimal, because reconstructive techniques are performed in less than 5% of them. Objective: To demonstrate that the placement of a silicone prosthesis in partial defects generated by breast cancer conservative surgery improves the aesthetic result, compared to the usual surgical technique, safely, reproducibly and compatible with adjuvant treatments.

Methodology: Prospective randomized clinical trial, controlled with blind evaluator. Inclusion criteria: Women with breast cancer candidates for conservative surgery. Intervention: In the cases the study technique will be carried out consisting in the filling of the defect with a silicone prosthesis of size adjusted to it (2-4cm). Controls: usual surgical procedure. Main result variable: aesthetic results (visual analog scale) according to the patient, surgeon and blind external evaluator. Secondary variables: surgical complications, local complications derived from adjuvant treatments, rate of local recurrence, rate of reintervention due to affected margins, behavior in mammographic follow-up, professional satisfaction and impact on quality of life.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group intervention: Silicone prothesis; 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; Silicone prosthesis
ACTIVE_COMPARATOR: Group control: Usual surgical technique; 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; Usual surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications	Incidence of surgical complications.	4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): July 29, 2021
• Study Completion (ACTUAL): March 1, 2022

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (ACTUAL): September 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Breast Conserving Surgery; Breast Neoplasms
• Other Study ID Numbers: IIBSP-SIL-2017-70

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No