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

NCT06779019 | Completed

• 1 other identifier: ZS-3103
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Flap Necrosis

Keywords

LSCI; ICG; breast reconstruction; implant-based breast reconstruction; flap necrosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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).

Diagnostic Test: LSCI; Diagnostic Test: ICG (Indocyanine Green)

Interventions

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.

patients underwent immediate direct-to-implant reconstruction

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.

patients underwent immediate direct-to-implant reconstruction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

female patients who received mastectomy and immediate direct-to-implant reconstruction

You may qualify if:

• All patients presenting for implant-base reconstruction immediately after mastectomy

You may not qualify if:

• delayed reconstruction, expander removal followed by prothesis implant, ICG allergy or intolerance, autologous reconstruction

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• China Medical Board (CMB): collaborator

Study Sites (1)

Pumch

Beijing, Beijing Municipality, 100032, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: September 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 16, 2025

Record last verified: 2023-10

Locations

CN (1)