Breast Reconstruction, Flap Necrosis
Conditions
Keywords
LSCI, ICG, breast reconstruction, implant-based breast reconstruction, flap necrosis
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.
Interventions
DIAGNOSTIC_TESTLSCI
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_TESTICG (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
China Medical Board (CMB)
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| necrosis | 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. |
Countries
China
Outcome results
None listed