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

NCT ID: NCT06779019

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-07-01

Brief Summary

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.

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.

Conditions

Breast Reconstruction; Flap Necrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

LSCI

Intervention Type: DIAGNOSTIC_TEST

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.

ICG (Indocyanine Green)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

China Medical Board (CMB)

UNKNOWN

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pumch

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ZS-3103

Identifier Type: -

Identifier Source: org_study_id