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Completed

NCT Number: NCT06779019

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

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.

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Key information

Conditions

Breast Reconstruction Flap Necrosis

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Pumch

Beijing, Beijing Municipality, 100032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LSCI

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)

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.

Primary outcomes

  1. necrosis

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • China Medical Board (CMB)

Registry information

Official study title

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

Acronym: BEST

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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