Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction

NCT03757793 | Terminated FDA Device

• 1 other identifier: 18/12/173
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mastectomy; Breast Reconstruction; Flap Ischemia

Keywords

Near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 72 hours post surgery

Study Arms (1)

Reliability of NIRS in DIEP flap surgery

In patients who underwent DIEP flap surgery, monitoring of postoperative tissue oxygen saturation of the flap by use of the FORE-SIGHT Elite monitor will be compared to standard of care physical examination.

Device: FORE-SIGHT ELITE monitor

Interventions

FORE-SIGHT ELITE monitor DEVICE

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.

Reliability of NIRS in DIEP flap surgery

Eligibility Criteria

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

Study Population

Women, over 18 years, undergoing unilateral or bilateral DIEP flap procedure

You may qualify if:

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

You may not qualify if:

• refusal of written informed consent
• redo-surgery
• known history of allergy to adhesives

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Study Officials

• Vera Saldien, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: data manager

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: September 28, 2018
• Primary Completion: May 22, 2025
• Study Completion: September 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

BE (1)