NCT06216106

Data Collection of Prepectoral Breast Reconstruction With Polyurethane Implantes

Prepectoral Breast Reconstruction With Polyurethane Implantes and Radiotherapy: a Single Center Retrospective Study Evaluating Risk and Complications

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 237 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: —

Summary

The goal of this observational study is to learn about correct surgical indications and long-term complications in patient with immediate prepectoral breast reconstruction with polyurethane implants. The main question it aims to answer are: what are the correct indications for this type of reconstruction? what is the complications rates? are the complications affected by pre and post operative radiotherapy? It's a retrospective study of all the patients that received prepectoral breast reconstruction with polyurethane implants without any exclusion factors. Researchers will compare the non-irradiated group with the patients with pre and post radiation therapy.

Detailed description

The study is a data collection of 250 patients for a total of 317 breasts underwent prepectoral breast recosntruction with polyurethane implantes. It is a retrospective study of a single center. The investigators gave indication to that type of reconstruction only to patients with good thickness (\> 0.5 cm) and vascularity of skin flap after mastectomy. The investigators used not selective criteria regarding risk factors so to better evaluate wich of them has a negative trend on the success of the reconstruction and on the major and minor complications. In that way the investigators tried to definde clarly the correct indications for this type of reconstruction. In addition, the investigators would like to define if the postoperative radiation therapy agument the complications rate and the capsular contracture incidence. The investigators decide to perform prepectoral breast reconstruction also in 20 patientes underwent previous radiotherapy dependig on the grade of cutaneus radiodistrophy, so to propose our less invasive approach to these patients normally candidates to autologus breast reconstruction

Conditions

• Prepectoral Breast Reconstruction
• Breast Reconstruction
• Radiation Therapy Complication

Interventions

Type	Name	Description
PROCEDURE	Prepectoral breast reconstruction with polyurethane implants	Breast reconstruction in the prepectoral plane without elevate the pectoralis major muscle. We choose this type of reconstruction only in patients with mastectomy flap thickness of plus then 0.5 cm. We usally use silicone implants covered by an external layer of polyurethane so not to put directly in contact the silicone with the subcutaneus tissue.

Timeline

• Start date: 2020-03-18
• Primary completion: 2022-12-22
• Completion: 2023-10-05
• First posted: 2024-01-22
• Last updated: 2024-01-22

Locations

1 site across 1 country: Italy