Wireless Laser Speckle Contrast Imaging Device for the visualisation of the microcirculatory during DIEP flap breast reconstruction.

Wireless Laser Speckle Contrast Imaging Device for the visualisation of the microcirculatory during DIEP flap breast reconstruction. - Wireless LSCI device during DIEP flap breast reconstruction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56060

Enrollment

Registered

2022-07-05

Start date

2022-11-28

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perfusion of flap during and (perfusion-related) complications after DIEP flap breast reconstruction

Interventions

&nbsp

Not applicable.&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria:  - >= 18 years of age - An indication for a unilateral or bilateral DIEP flap breast reconstruction, either immediate or delayed - Patients must be willing to give informed consent 

Exclusion criteria

Exclusion criteria:  - Patients unwilling or unable to give informed consent 

Design outcomes

Primary

Measure	Time frame
The main study parameter will be: The mean perfusion in PU of the newly reconstructed breast correlated to the occurrence of absence of perfusion-related complications.	—

Secondary

Measure	Time frame
The secondary study endpoints will be:Visualisation of the perfusion of the abdominal flap during five moments the measurements will be performed.Applicability and efficiency of the method against motion artefacts.Feasibility and applicability of the WIPI that operates wireless and can preview perfusion frames in daily clinical practice.	—

Countries

Netherlands

Contacts

Public ContactW.D. Rinkel

Ziekenhuis Groep Twente (ZGT)

plastischechirurgie-zgt@zgt.nl+31 88 708 52 45

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)