Monitoring tissue oxygenation during breast reconstruction
Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
University Hospital, Antwerp · NCT03757793
This study tests if a special monitor can help doctors see how well the tissue is getting oxygen during breast reconstruction surgery to catch any problems early and improve recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Antwerp (other) |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT03757793 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of near-infrared spectroscopy (NIRS) in detecting early microvascular complications in patients undergoing deep inferior epigastric artery perforator (DIEP) flap breast reconstruction following mastectomy. The research aims to improve postoperative monitoring by using the FORE-SIGHT ELITE monitor, which provides a non-invasive method to assess tissue oxygenation. By continuously monitoring the flap during the critical first 12 hours post-surgery, the study seeks to identify complications early, potentially enhancing flap survival rates. The approach aims to provide a more objective and efficient alternative to traditional physical examination methods.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective unilateral or bilateral breast reconstruction using the DIEP flap technique.
Not a fit: Patients who may not benefit include those undergoing redo-surgery or those with known allergies to adhesives.
Why it matters
Potential benefit: If successful, this method could significantly reduce the risk of flap failure and improve outcomes for patients undergoing breast reconstruction.
How similar studies have performed: While the use of NIRS in surgical settings is gaining attention, this specific application for monitoring DIEP flap reconstructions is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edegem, Antwerp
- University hospital Antwerp — Edegem, Antwerp, Belgium (RECRUITING)
Study contacts
- Principal investigator: Vera Saldien, MD — University Hospital, Antwerp
- Study coordinator: Vera Saldien, MD
- Email: vera.saldien@uza.be
- Phone: 38214788
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mastectomy, Breast Reconstruction, Flap Ischemia, Near infrared spectroscopy