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

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

Sponsors

Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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

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.

Overall Status Recruiting
Start Date September 18, 2019
Completion Date September 2022
Primary Completion Date March 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Aesthetic result 4 weeks
Secondary Outcome
Measure Time Frame
Surgical complications 4 weeks
Enrollment 100
Condition
Intervention

Intervention type: Device

Intervention name: Silicone prosthesis

Description: Silicone prosthesis

Arm group label: Group intervention: Silicone prothesis

Intervention type: Procedure

Intervention name: Usual practice

Description: Usual surgery

Arm group label: Group control: Usual surgical technique

Eligibility

Criteria:

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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Barbara Garcia-Valdecasas, MD

Phone: 935537041

Email: [email protected]

Location
facility status contact investigator
Hospital de la Santa Creu i Sant Pau Recruiting Barbara Garcia-Valdecasas, MD Barbara Garcia-Valdecasas, MD Principal Investigator
Location Countries

Spain

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Group intervention: Silicone prothesis

Arm group type: Experimental

Description: 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.

Arm group label: Group control: Usual surgical technique

Arm group type: Active Comparator

Description: 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.

Acronym PROSILMA
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Group whith silicone prothesis Group whith standard surgical procedure

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov