DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
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|ClinicalTrials.gov Identifier: NCT04115995|
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment|
|Reconstructive Surgical Procedures||Diagnostic Test: Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)|
'The primary aim of our study is to compare invasive and non-invasive techniques to select a dominant perforator when harvesting a DIEP-flap for autologous breast reconstruction.
The secondary aim is to compare Dynamic Infrared Thermography (DIRT) and Laser Fluorescence Angiography (LFA) of Indocyanine green (ICG) in order to see whether they could be useful in the early detection of insufficient perfusion following the microvascular anastomotic procedure in DIEP flaps.
Material and Method:
Patients selected for breast reconstruction with autologous tissue were examined with preoperative CTA and a handheld Doppler Ultrasound for perforator mapping. Thereafter visual images from same area was obtained with dynamic infraredeed thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) before and after dissection of the skin flap with preserved medial and lateral DIEP perforators. Reconstructed breasts with hemi-DIEP-flaps were intraoperatively evaluated with DIRT and LFA immediately after the completion and opening of the microvascular anastomosis.The recorded images from the different techniques were assesses in relation to clinical outcome.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||30 participants|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.|
|Actual Study Start Date :||January 16, 2019|
|Estimated Primary Completion Date :||December 24, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Diagnostic Test: Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)
DIRT and ICG FA are used intraoperatively to evaluate perfusion of the perforators and the anastomosis. Both technique are compared in their ability to visualize perfusion.
- Assessment of quality and location of perforating blood vessels with dynamic infrared thermography and indocyanine green angiography in autologous breast reconstruction: A comparative imaging study. [ Time Frame: 2 year ]Pre-and intraoperative use of two different imaging technologies to assess quality and location of perforating blood vessels in autologous breast reconstruction. In this study we will compare images obtained using a non-invasive imaging technique, dynamic infrared thermography and an invasive imaging technique, laser fluorescence angiography of indocyanine green.
- Quality of microvascular anastomosis by measuring perfusion through the anastomosis using dynamic infrared thermography and laser fluorescence angiography of indocyanine green. [ Time Frame: 2 years ]The microvascular anastomosis provides blood supply to tissue used in breast reconstruction. The blood flow through the microvascular anastomosis can be monitored by use of different imaging techniques. In this study, perfusion images obtained by non-invasive dynamic infrared thermography and invasive fluorescence angiography of indocyanine green will be compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115995
|Contact: Louis de Weerd, MD, PhD,||firstname.lastname@example.org|
|Univesity Hospital of North Norway||Recruiting|
|Tromsø, Norway, 9038|
|Contact: Louis de Weerd, MD, PhD 0047 77669793 louis.De.Weerd@unn.no|