NIR Device for Assessment of Skin Flap Perfusion in Breast Surgery: A Pilot Interventional Study

NCT07680296 | Completed

• 2 other identifiers: AdisirastIT-24-04-046716
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this single-center, nonrandomized, interventional non-profit pilot study is to evaluate the feasibility and clinical utility of a non-invasive near-infrared spectroscopy (NIRS) imaging device for assessing skin-flap tissue oxygen saturation in adult women undergoing mastectomy and immediate breast reconstruction after oncological surgery. The main questions it aims to answer are:

• Can NIRS imaging provide reproducible measurements of tissue oxygen saturation (StO₂) in mastectomy skin flaps before surgery, during the intraoperative phase, and during postoperative follow-up?
• Can spatial and temporal variations in StO₂ identify areas of potentially reduced flap perfusion or impaired tissue viability?
• Can NIRS-derived oxygenation measurements support the assessment of postoperative flap healing and ischemic complications? Participants will:
• undergo non-invasive NIRS imaging of the breast skin flap before surgery;
• undergo one intraoperative NIRS acquisition during mastectomy and immediate breast reconstruction;
• undergo repeated NIRS imaging during postoperative follow-up visits;
• receive standard surgical treatment and postoperative care according to routine clinical practice. NIRS imaging is performed for study purposes and does not influence intraoperative surgical decision-making or the choice of reconstructive procedure.

Conditions

Breast Cancer; Mastectomy; Breast Reconstruction

Keywords

Near-Infrared Spectroscopy; Tissue Oxygenation; Skin Flap Perfusion; Breast Reconstruction; Mastectomy

Outcome Measures

Primary Outcomes (3)

• Tissue Oxygen Saturation (StO₂) Measured by the Snapshot NIR V3.0 Device

  Superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 imaging device. StO₂ values (%) will be obtained from predefined Regions of Interest (ROIs) identified on exported two-dimensional tissue oxygenation maps. Mean StO₂ (%) and the presence of hypoperfused areas will be evaluated at each scheduled study visit.

  Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).

• Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Clinical Assessment of Breast Skin Flap Perfusion

  Correlation between superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device and the clinical assessment of breast skin flap perfusion performed by visual inspection. Clinical assessment findings and StO₂ measurements will be compared for the predefined Regions of Interest (ROIs). The outcome will be expressed as a correlation coefficient between StO₂ (%) measurements and the corresponding clinical assessment.

  Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).

• Temporal Change in Tissue Oxygen Saturation (StO₂) of Breast Skin Flaps

  Change in superficial tissue oxygen saturation (StO₂, %) measured using the Snapshot NIR V3.0 device over time. Serial StO₂ measurements obtained from predefined Regions of Interest (ROIs) will be compared across study visits to evaluate the temporal evolution of tissue perfusion and hypoperfused areas.

  Baseline (preoperative), postoperative day 1, and postoperative day 15 (±5 days).

Secondary Outcomes (1)

• Correlation Between Snapshot NIR Tissue Oxygen Saturation (StO₂) and Intraoperative Reconstructive Strategy

  Intraoperative.

Study Arms (1)

Snapshot NIR Assessment

EXPERIMENTAL

Each patient enrolled in the study will undergo the standard diagnostic and treatment process. The only difference compared to patients not enrolled in the study will be the use of the experimental Snapshot NIR V3.0 device during the routine visits scheduled in any case, and in particular: during the preoperative consultation between the plastic surgeon and the breast surgeon, which must take place within 30 days prior to surgery; during the pre- and post-operative phases; on the first post-operative day during hospitalization; and on the 15th (+/-5 days) post-operative day during one of the routinely scheduled dressing changes.

Device: Snapshot NIR V3.0

Interventions

Snapshot NIR V3.0 DEVICE

The Snapshot NIR V3.0 device is used to noninvasively assess superficial breast skin flap tissue oxygenation and perfusion. NIR images and tissue oxygen saturation measurements are acquired preoperatively, early postoperatively, and at a later postoperative assessment.

Snapshot NIR Assessment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex, aged 18 to 90 years.
• Breast cancer patients scheduled for mastectomy with immediate reconstruction using an implant or tissue expander; or healthy BRCA mutation carriers scheduled for prophylactic mastectomy.
• No previous radiotherapy to the chest wall.
• No previous neoadjuvant chemotherapy.

You may not qualify if:

• Severe psychiatric disorders.
• Advanced malignancy.
• Severe aortic stenosis.
• Obstructive hypertrophic cardiomyopathy.
• Severe chronic kidney disease.
• Severe chronic obstructive pulmonary disease.
• Uncontrolled diabetes mellitus.
• Advanced peripheral arterial occlusive disease (Leriche-Fontaine class III).
• Use of benzodiazepines, non-benzodiazepine hypnotics, typical or atypical antipsychotics, antidepressants, or anticonvulsants without a stable dose for at least 4 months.
• Alcohol, caffeine, or other substance abuse.
• Inability to reasonably adhere to study procedures.
• Pregnancy or breastfeeding.
• Concurrent participation in another clinical trial.
• Withdrawal of informed consent.

Sponsors & Collaborators

• National Research Council, Institute of Clinical Physiology, Italy: lead

Study Sites (1)

U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP) Presidio Ospedaliero Santa Chiara

Pisa, 56126, Italy

Location

Related Publications (7)

• Trivella MG, Piersigilli A, Bernini F, Pelosi G, Burchielli S, Puzzuoli S, Kusmic C, L'Abbate A. Percutaneous cardiac support during myocardial infarction drastically reduces mortality: perspectives from a swine model. Int J Artif Organs. 2017 Jul 5;40(7):338-344. doi: 10.5301/ijao.5000604. Epub 2017 Jun 6.

  PMID: 28604999 BACKGROUND

• Jalil B, Hartwig V, Moroni D, Salvetti O, Benassi A, Jalil Z, Pistoia L, Minutoli Tegrimi T, Quinones-Galvan A, Iervasi G, L'Abbate A, Guiducci L. A Pilot Study of Infrared Thermography Based Assessment of Local Skin Temperature Response in Overweight and Lean Women during Oral Glucose Tolerance Test. J Clin Med. 2019 Feb 19;8(2):260. doi: 10.3390/jcm8020260.

  PMID: 30791407 BACKGROUND

• Hartwig V, Guiducci L, Marinelli M, Pistoia L, Tegrimi TM, Iervasi G, Quinones-Galvan A, L'Abbate A. Multimodal Imaging for the Detection of Brown Adipose Tissue Activation in Women: A Pilot Study Using NIRS and Infrared Thermography. J Healthc Eng. 2017;2017:5986452. doi: 10.1155/2017/5986452. Epub 2017 Sep 14.

  PMID: 29104746 BACKGROUND

• Jalil B, Salvetti O, Poti L, Hartwig V, Marinelli M, L'Abbate A. Near infrared image processing to quantitate and visualize oxygen saturation during vascular occlusion. Comput Methods Programs Biomed. 2016 Apr;126:35-45. doi: 10.1016/j.cmpb.2015.12.001. Epub 2015 Dec 17.

  PMID: 26725781 BACKGROUND

• Jalil B, Hartwig V, Salvetti O, Poti L, Gargani L, Barskova T, Matucci Cerinic M, L'Abbate A. Assessment of hand superficial oxygenation during ischemia/reperfusion in healthy subjects versus systemic sclerosis patients by 2D near infrared spectroscopic imaging. Comput Methods Programs Biomed. 2018 Mar;155:101-108. doi: 10.1016/j.cmpb.2017.12.006. Epub 2017 Dec 12.

  PMID: 29512489 BACKGROUND

• Gargani L, Bruni C, Barskova T, Hartwig V, Marinelli M, Trivella MG, Matucci-Cerinic M, L'Abbate A. Near-infrared spectroscopic imaging of the whole hand: A new tool to assess tissue perfusion and peripheral microcirculation in scleroderma. Semin Arthritis Rheum. 2019 Apr;48(5):867-873. doi: 10.1016/j.semarthrit.2018.08.002. Epub 2018 Aug 11.

  PMID: 30205980 BACKGROUND

• Longobardi P, Hartwig V, Santarella L, Hoxha K, Campos J, Laurino M, Salvo P, Trivella MG, Coceani F, Rocco M, L'Abbate A. Potential markers of healing from near infrared spectroscopy imaging of venous leg ulcer. A randomized controlled clinical trial comparing conventional with hyperbaric oxygen treatment. Wound Repair Regen. 2020 Nov;28(6):856-866. doi: 10.1111/wrr.12853. Epub 2020 Aug 24.

  PMID: 32789935 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Matteo Ghilli, MD

  U.O. Senologia, Azienda Ospedaliero-Universitaria Pisana (AOUP)

  PRINCIPAL INVESTIGATOR

• Valentina Hartwig, PhD

  National Research Council, Institute of Clinical Physiology, Italy

  STUDY CHAIR

• Maria Giovanna Trivella, MD

  National Research Council, Institute of Clinical Physiology, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 2, 2026
• Study Start: October 10, 2024
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)