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| Name | Class |
|---|---|
| China Medical Board (CMB) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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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
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female patients who received mastectomy and immediate direct-to-implant reconstruction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pumch | Beijing | Beijing Municipality | 100032 | China |
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| 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. |
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