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

NCT06779019 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-01-16

No results posted yet for this study

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.

Conditions

  • Breast Reconstruction
  • Flap Necrosis

Interventions

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.

Sponsors & Collaborators

  • China Medical Board (CMB)

    collaborator UNKNOWN

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-07-01
Completion
2024-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779019 on ClinicalTrials.gov