Evaluation of the Effectiveness of Prepectoral Breast Reconstruction

Sponsor
European Institute of Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT05125991
Collaborator
(none)
58
Enrollment
1
Location
2
Arms
51.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Prepectoral reconstruction
  • Procedure: Submuscolar reconstruction
N/A

Detailed Description

The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.

The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.

Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study
Actual Study Start Date :
Sep 3, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Prepectoral reconstruction

Prepectoral breast reconstruction with Braxon dermal matrix

Procedure: Prepectoral reconstruction
Prepectoral breast reconstruction

Active Comparator: Submuscular reconstruction

Submuscolar breast reconstruction

Procedure: Submuscolar reconstruction
Submuscolar breast reconstruction

Outcome Measures

Primary Outcome Measures

  1. Satisfaction assessed by the BREAST-Q [1 year]

    The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

Secondary Outcome Measures

  1. Immediate complications rate [1 month]

    Compare post operative complications

  2. Short term complications rate [6 months]

    Compare short term post operative complications

  3. Long term complications rate [24 months]

    Compare long term post operative complications

  4. Percentage of capsular contracture [1 year]

    Compare overall aesthetic outcomes (percentage of capsular contracture) using standardized photographs assessed by independent blinded observers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Informed consent

  2. Not smokers

  3. No vascular comorbidities (diabetic, vasculitis, coagulation disorders)

  4. BMI<30

  5. CUP B-C (or mastectomy estimated weight less than 550gm)

  6. Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant)

  7. No previous breast surgery

  8. No previous breast irradiation

  9. Breast Ptosis 1-2 according to Renault's classification

  10. DCIS tumors

  11. T1 T2 pN0 breast tumor with known favourable biologic features

Exclusion Criteria:
  1. Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)

  2. Positive sentinel node biopsy requiring complete axillary dissection

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1European Institute of OncologyMilanItaly20141

Sponsors and Collaborators

  • European Institute of Oncology

Investigators

  • Principal Investigator: Francesca De Lorenzi, PhD, MD, European Institute of Oncology
  • Principal Investigator: Paolo Veronesi, MD, European Institute of Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT05125991
Other Study ID Numbers:
  • IEO 1002/
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021