a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction (BEST)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Breast Reconstruction; Flap Necrosis

Treatments: Diagnostic Test: ICG (Indocyanine Green); Diagnostic Test: LSCI

Study type: Observational

Funder types: Other

Identifiers

NCT06779019

ZS-3103

Details and patient eligibility

About

This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.

Full description

This study prospectively evaluates and compares the effectiveness of Indocyanine Green (ICG) fluorescence imaging and Laser Speckle Contrast Imaging (LSCI) in predicting the risk of necrosis following direct-to-implant breast reconstruction. The investigation includes both intraoperative and postoperative assessments of flap perfusion, with a focus on identifying specific thresholds for necrosis prediction. By analyzing the sensitivity, specificity, and predictive accuracy of each technique, the study aims to establish their respective strengths and limitations. Additionally, the research aims to explore the feasibility of using these methods in different surgical stages, evaluating their consistency and reliability in monitoring the viability of the skin flap and nipple-areolar complex.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients presenting for implant-base reconstruction immediately after mastectomy

Exclusion criteria

delayed reconstruction, expander removal followed by prothesis implant, ICG allergy or intolerance, autologous reconstruction

Trial design

40 participants in 1 patient group

patients underwent immediate direct-to-implant reconstruction

Description:

Patients undergoing nipple-sparing mastectomy (NSM) received flap evaluations for both the nipple-areolar complex (NAC) and the peri-incision skin flap. Perfusion of the skin flap and nipple was assessed using both Laser Speckle Contrast Imaging (LSCI) and Indocyanine Green (ICG) fluorescence imaging at two critical time points: immediately after the mastectomy (prior to immediate reconstruction) and again following reconstruction (after the skin was sutured).

Treatment:

Diagnostic Test: LSCI

Diagnostic Test: ICG (Indocyanine Green)