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

Breast Enhanced Strategies and Techniques(BEST) (Focus on Chinese Breast Reconstruction) Trial PART 1: Evaluation of Predictive Methods of Reconstruction Outcomes--Flap Perfusion Analysis

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.

Study Overview

• Status: Completed
• Conditions: Breast Reconstruction; Flap Necrosis
• Intervention / Treatment: Diagnostic test: LSCI; Diagnostic test: ICG (Indocyanine Green)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • PUMCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

female patients who received mastectomy and immediate direct-to-implant reconstruction

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients underwent immediate direct-to-implant reconstruction; 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).

Diagnostic test: LSCI; LSCI evaluates at 2 timings:immediately after the mastectomy (prior to immediate reconstruction) and again following reconstruction (after the skin was sutured). The perfusion score was calculated by normalizing these values against the perfusion value of a control.; Diagnostic test: ICG (Indocyanine Green); Performed immediately after the mastectomy (prior to immediate reconstruction) .Perfusion scores were determined by comparing the fluorescence intensity of the target area to that of the non-surgical region on the contralateral chest wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
necrosis	Signs of necrosis included: (1) swelling or blistering, (2) dark brown or dark blue discoloration of the flap or nipple-areolar complex (NAC), (3) scab formation, (4) wound disruption, and (5) sloughing of the NAC or local flap. Severe necrosis was defined as either (4) or (5), necessitating debridement and secondary closure surgery.	3 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: China Medical Board (CMB)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: January 12, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ICG; breast reconstruction; LSCI; implant-based breast reconstruction; flap necrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: ZS-3103

Drug and device information, study documents

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