Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction

Breast Reconstruction Clinical Trial

Official title:

Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03757793
• Other study ID #: 18/12/173
• Status: Recruiting
• Start date: September 28, 2018
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Antwerp
• Contact: Vera Saldien, MD
• Phone: 38214788
• Email: vera.saldien[@]uza.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).

Description:

After a complex resection for breast cancer (e.g. mastectomy), a microvascular flap reconstruction can be used to fill up the tissue defects. A deep inferior epigastric artery perforator (DIEP)-flap is one of the most used microvascular flap reconstructions. Skin and fat from the abdomen are used to reconstruct a new breast.The success ratio of this type of surgery is high, more than 95%. Nevertheless, free flap failure can have disastrous consequences.The flap can be injured by surgical factors such as vascular complications.This is one of the major concerns and it usually occurs in the first hours after surgery. The success rate of the free flap depends on the continuous arterial inflow and the venous outflow through the new microvascular anastomoses. Thrombosis, kinking or external compression on the micro- and macrovascular blood vessels can cause necrosis of the flap. It is essential to recognize these complications as fast as possible to maximize the potential for flap salvage. Physical examination is still the gold standard for flap monitoring. However this monitoring is subjective, labor intensive and requires experience. Because of these disadvantages, a more objective method is desirable. In this suggested project, the flap will be monitored with FORE-SIGHT ELITE monitor( CAS Medical Systems incorporated) during the first 12 hours postoperatively. In this period most complications occur. The FORE-SIGHT ELITE Absolute Tissue Oximeter is a non-invasive device that measures absolute tissue oxygen saturation. It operates on the principle that blood contains hemoglobin in two primary forms, oxygenated hemoglobin (HbO2 ) and de-oxygenated hemoglobin (Hb), which absorb near-infrared light in different, measurable ways.The FORE-SIGHT ELITE incorporates CAS Medical Systems exclusive technology to project harmless near-infrared light in five precise wavelengths (690, 730, 770, 810 and 870 nanometer). An algorithm analyzes the reflected wavelengths. The algorithm is specially designed for the tissue with attention to unique characteristics of the tissue. Reflected light is captured by detectors positioned on the sensor for optimal signal collection. After analyzing the reflected light, the FORE-SIGHT ELITE displays the tissue oxygen saturation level on the monitor as an absolute number and provides a graphical representation of historical values.The FORE-SIGHT ELITE has been validated to determine cerebral tissue oxygen saturation amongst other in brain surgery. Tissue oxygen saturation (StO2) levels are determined by the ratio of oxygenated hemoglobin to total hemoglobin at the microvascular level (arterioles, venules, and capillaries) in the region to which the sensor is applied. This technique is called Near Infrared Spectroscopy (NIRS).Validated use of NIRS would be a major advantage to detect ischaemia in DIEP flaps. In the study pediatric sensor size is used to ensure proper depth of light penetration in a limited operating zone. By application of small neonatal sensors ( Foresight®-sensors (CASMED, Branford, CT, USA), on unilateral or bilateral DIEP flaps,light penetrates at 1.25cm depth.This reflects the perfusion and the oxygen consumption in the free flap.

A control pediatric sensor is placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects the normal tissue oxygenation of the patient. NIRS uses this technology for the detection of ischemia and hypoxia. It is a real-time, continuous, non-invasive method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled for elective unilateral or bilateral breast reconstruction via DIEP flap procedure.

Exclusion Criteria:

• refusal of written informed consent

• redo-surgery

• known history of allergy to adhesives

Related Conditions & MeSH terms

• Breast Reconstruction
• Flap Ischemia
• Ischemia
• Mastectomy

Intervention

Device:
• FORE-SIGHT ELITE monitor
At end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring.

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of ischaemia after DIEP flap surgery by use of NIRS	The aim of the study is to determine whether near infrared spectrometry(NIRS) would be a validated tool to detect early microvascular complications. A decrease of 10% of the Sct O2 taken at the DIEP flap(s) compared to Sct O2 of the abdomen will be considered as possible risk of ischaemia.	first 12 hours post surgery