Our mission is to improve orthopedic care in conflict zones by using innovative research and a technology called Fluorescence-Guided Debridement (FGD). This approach gives surgeons real-time information about the health of bones and tissues during surgery, helping them work more accurately. In emergency situations with many injured patients, FGD can make surgeries more efficient and help antibiotics work better, ultimately leading to better recovery and survival rates for patients.

Infection is a serious and common problem for people who suffer injuries to their arms and legs, affecting 10-50% of patients. In conflict situations, like the ongoing fighting in Eastern Ukraine, about 75% of injured soldiers and civilians have these types of injuries, mostly caused by artillery and high-powered gunfire. Despite many years of research, current treatments fail about 33% of the time when infections occur, which can lead to long recovery times, loss of function, and in some cases, loss of limbs. One reason for this is the lack of a clear method to assess blood flow in the bones during surgery, which can lead to inadequate cleaning of the wound.

Schematic showing how FGD works. (a) dye is administered i.v. while (b) imaging with white and near-infrared light. The resulting fluorescence images (c) are then processed to produce predictive maps of infection risk.

Fluorescence-Guided Debridement is an objective intraoperative tool that can provide surgeons with real-time critical information needed to optimize the debridement. This technology helps them carefully remove damaged bone while keeping healthy tissue intact. By using this method, the chances of treatment failures decrease, and it can make surgeries more consistent, which is especially useful for less experienced surgeons. It also aims to reduce the number of times a patient needs to undergo the procedure by ensuring the best possible outcome on the first attempt, which can ultimately lower the burden on a healthcare system that is overwhelmed by the casualties of war.

Fluorescence-Guided Debridement (FGD) uses a special dye called indocyanine green (ICG) to help doctors see blood flow and assess tissue health during surgery. When ICG is injected into the bloodstream, it stays mostly within the blood vessels and lymphatic system, making it effective for measuring blood flow. The dye has a short lifespan in the body, which allows for repeated checks during the procedure. When exposed to specific light, ICG emits a signal that can be captured on video. By recording and analyzing the signal as the dye washes into the bone and then back out, we can calculate important information about blood flow and provide the surgeon with a map of the relative health of the bone and tissue they are looking at. This helps surgeons identify areas at risk for complications and guides them in removing damaged tissue more accurately.

FGD Visualization
(Warning: Surgical images which may be graphic for some.)

Figure. FGD transforms what the surgeon sees into a “risk map”, providing clear feedback on how retained tissue will put the patient at risk for surgical site infection.

a dartmouth success story

Innovative Technology

A research team led by Dr. Leah Gitajn in the Department of Orthopaedics at Dartmouth Health developed the innovative FGD approach

Over the past 5 years, conducted clinical trials funded by the NIH and DOD to understand the value of FGD in patients with open fracture and surgical site infection.

A prospective trial with 110 SSI patients demonstrated that low post-debridement bone perfusion strongly predicts early infection recurrence, indicating that more precise debridement may substantially reduce treatment failure rate.

Patients who experienced early recurrence of infection had significantly lower average blood flow and fluorescence than those who remained free of infection. Moreover, retention of a large low perfusion area (LPA) post-debridement was strongly associated with early infection recurrence and treatment failure with univariate analysis (OR 8.8, p = 0.001) and Kaplan Meier survival analysis (p=0.021). Retained LPA of >12% the total debridement area was associated with an 89% sensitivity to predict infection recurrence.

(a) Large retained low-perfusion bone area (LPA) (red line) was statistically significantly associated with increased recurrence rate in Kaplan Meier analysis (p=0.021). (b) In 56% of patients a large LPA (>12%) was retained post-debridement even with experienced fellowship-trained surgeons.

In another contemporaneous trial, 118 patients with acute open fracture were imaged post-debridement, prior to fracture fixation which demonstrated a statistically significant association between large area of low post-debridement perfusion and development of infection (p = 0.03).

Even the highly experienced, fellowship-trained orthopaedic trauma surgeons who participated in these trials left large amounts of devitalized bone. During the R01-funded trial, 56% of patients (58 out of 201) were left with large, clinically relevant low-perfusion areas (threshold < 12%).

The integration of fluorescence imaging into the surgical workflow itself marks a substantial innovation. In addition, the Dartmouth team developed advanced hardware and software solutions, incorporating AIF and motion correction algorithms, establishing critical thresholds and implementing auto-segmenting for blood and other tissue types.

Paradigm shift in surgical management of SSI after fracture

This technology represents a paradigm shift with FGD as a major innovation by objectively assessing bone perfusion during surgery to improve precision. This is the first method to effectively assess intraoperative bone perfusion, grounded by data from over 200 patients in two prospective trials demonstrating a link between low post-debridement perfusion and recurrent infection. These findings underscore the critical need for removal of poorly perfused bone, which is often underestimated even by experienced surgeons. FGD thus represents a pivotal innovation in surgical management

Lumine is collaborating with Dartmouth-Hitchcock innovations to advance FGD even further, to ensure it is adapted for the hostile operational environment of Eastern Ukraine.

Technical innovations:

Quantitative fluorescence imaging using in situ phantom for real-time calibration
Arterial input function capture and correction of patient-specific delivery.
Analysis of kinetic variables to assess bone hemodynamics.
“Traffic light” classification of pixels as “normal,” “suspicious,” or “compromised” to assist decision-making.
Incorporating of patient-specific factors in predictive modeling.
Automatic surgical field detection to enhance data visualization.
Exclusion of artifacts from blood interference.
Auto-segmentation of bone from surrounding tissues for clearer data display.
Dual-channel fluorescence imaging for improved accuracy and compliance assessment.

We seek funding from donors to fund a clinical investigation that will demonstrate the safety and effectiveness of FGD in the hospitals of Eastern Ukraine, and quickly obtain the necessary approvals to supply Ukraine with this technology.

Caution: Investigational Device, Limited by united states Law to Investigational UsE

The technology discussed on this website is currently under investigation for the indications described. Research undertaken by Lumine in collaboration with researchers in the US and in Ukraine will further efforts for this technology to be cleared.

Publications

1: Tang Y, Jiang S, Sottosanti JS, Usherwood T, Cao X, Bateman LM, Fisher LA, Henderson ER, Gitajn IL, Elliott JT. Patient-specific arterial input function for accurate perfusion assessment in intraoperative fluorescence imaging. J Biomed Opt. 2024 Jun;29(Suppl 3):S33306. doi: 10.1117/1.JBO.29.S3.S33306. Epub 2024 Sep 6. PMID: 39247899; PMCID: PMC11379448.

2: Yue Tang, Ida Leah Gitajn, Xu Cao, Xinyue Han, Jonathan T Elliott, Logan M Bateman, Bethany S Malskis, Lillian A Fisher, Jessica M Sin, Eric R Henderson, Shudong Jiang. Automatic correction of motion artifact in dynamic contrast-enhanced fluorescence imaging during open orthopedic surgery. J Biomed Opt. 2024 Jan; 29(1):016001. doi: https://doi.org/10.1117/1.JBO.29.1.016001. Epub 2024 Jan 3. PMID: in process; PMCID: in process.

3: Elliott JT, Henderson E, Streeter SS, Demidov V, Han X, Tang Y, Sottosanti JS, Bateman L, Brůža P, Jiang S, Gitajn IL. Fluorescence-guided and molecularly-guided debridement: identifying devitalized and infected tissue in orthopaedic trauma. Proc SPIE Int Soc Opt Eng. 2023 Jan-Feb;12361:1236108. doi:10.1117/12.2661243. Epub 2023 Mar 14. PMID: 37056956; PMCID: PMC10091097.

4: Tang Y, Gitajn IL, Cao X, Han X, Elliott JT, Yu X, Bateman LM, Malskis BS, Fisher LA, Sin JM, Henderson ER, Pogue BW, Jiang S. Automated motion artifact correction for dynamic contrast-enhanced fluorescence imaging during open orthopedic surgery. Proc SPIE Int Soc Opt Eng. 2023 Jan-Feb;12361:1236104. doi:10.1117/12.2650028. Epub 2023 Mar 14. PMID: 37034556; PMCID: PMC10078951.

5: Streeter SS, Hebert KA, Bateman LM, Ray GS, Dean RE, Geffken KT, Resnick CT, Austin DC, Bell JE, Sparks MB, Gibbs SL, Samkoe KS, Gitajn IL, Elliott JT, Henderson ER. Current and Future Applications of Fluorescence Guidance in Orthopaedic Surgery. Mol Imaging Biol. 2023 Feb;25(1):46-57. doi:10.1007/s11307-022-01789-z. Epub 2022 Nov 29. PMID: 36447084; PMCID:PMC10106269.

6: Demidov VV, Clark MA, Streeter SS, Sottosanti JS, Gitajn IL, Elliott JT. High-energy open-fracture model with initial experience of fluorescence-guided bone perfusion assessment. J Orthop Res. 2023 May;41(5):1040-1048. doi:10.1002/jor.25443. Epub 2022 Oct 3. PMID: 36192829; PMCID: PMC10067537.

7: Han X, Demidov V, Vaze VS, Jiang S, Gitajn IL, Elliott JT. Spatial and temporal patterns in dynamic-contrast enhanced intraoperative fluorescence imaging enable classification of bone perfusion in patients undergoing leg amputation. Biomed Opt Express. 2022 May 3;13(6):3171-3186. doi:10.1364/BOE.459497. PMID:35781962; PMCID: PMC9208615.

8: Tang Y, Sin JM, Gitajn IL, Cao X, Han X, Elliott JT, Yu X, Christian ML, Bateman L, Chockbengboun T, Henderson ER, Pogue BW, Jiang S. Dynamic contrast-enhanced fluorescence imaging compared with MR imaging in evaluating bone perfusion during open orthopedic surgery. Proc SPIE Int Soc Opt Eng. 2022 Jan-

Feb;11943:119430C. doi: 10.1117/12.2608382. Epub 2022 Mar 4. PMID: 36061412; PMCID: PMC9430826.

9: Sepehri A, Slobogean GP, O’Hara NN, McKegg P, Rudnicki J, Atchison J, O’Toole RV, Sciadini MF, LeBrun CT, Nascone JW, Johnson AJ, Gitajn IL, Elliott JT, Scolaro JA, Pensy RA. Assessing Soft Tissue Perfusion Using Laser-Assisted Angiography in Tibial Plateau and Pilon Fractures: A Pilot Study. J Orthop Trauma. 2021 Dec 1;35(12):626-631. doi: 10.1097/BOT.0000000000002100. PMID: 34797781; PMCID: PMC8918020.

10: Jiang S, Elliott JT, Xing J, Cao X, Yu X, Han X, Dabrowski RE, Christian ML, Henderson ER, Pogue BW, Gitajn IL. ICG-based dynamic contrast-enhanced fluorescence imaging guided open orthopaedic surgery: pilot patient study. Proc SPIE Int Soc Opt Eng. 2021 Mar;11625:116250W. Epub 2021 Mar 5. PMID: 36082047; PMCID: PMC9451047.

11: Elliott JT, Jiang S, Henderson ER, Slobogean GP, O’Hara NN, Xu C, Xin J, Han X, Christian ML, Gitajn IL. Intraoperative assessment of bone viability through improved analysis and visualization of dynamic contrast-enhanced fluorescence imaging: technique report. OTA Int. 2022 Dec;5(4):e222. doi: 10.1097/OI9.0000000000000222. eCollection 2022 Dec. PubMed PMID: 36569105; PubMed Central PMCID: PMC9782343.

12: Gitajn IL, Elliott JT, Gunn JR, Ruiz AJ, Henderson ER, Pogue BW, Jiang S. Evaluation of bone perfusion during open orthopedic surgery using quantitative dynamic contrast-enhanced fluorescence imaging. Biomed Opt Express. 2020 Oct 19;11(11):6458-6469. doi: 10.1364/BOE.399587. PMID: 33282501; PMCID: PMC7687926.

13: Gitajn IL, Slobogean GP, Henderson ER, von Keudell AG, Harris MB, Scolaro JA, O’Hara NN, Elliott JT, Pogue BW, Jiang S. Perspective on optical imaging for functional assessment in musculoskeletal extremity trauma surgery. J Biomed Opt. 2020 Aug;25(8):080601. doi: 10.1117/1.JBO.25.8.080601. PMID: 32869567; PMCID: PMC7457961.

14: Elliott JT, Addante RR, Slobegean GP, Jiang S, Henderson ER, Pogue BW, Gitajn IL. Intraoperative fluorescence perfusion assessment should be corrected by a measured subject-specific arterial input function. J Biomed Opt. 2020 Jun;25(6):1-14. doi: 10.1117/1.JBO.25.6.066002. PMID: 32519522; PMCID: PMC7282620.

15: Jiang S, Elliott JT, Gunn JR, Xu C, Ruiz AJ, Henderson ER, Pogue BW, Gitajn IL. Endosteal and periosteal blood flow quantified with dynamic contrast-enhanced fluorescence to guide open orthopaedic surgery. Proc SPIE Int Soc Opt Eng. 2020 Feb;11222:112220F. doi: 10.1117/12.2546173. Epub 2020 Feb 19. PMID: 32483397; PMCID: PMC7263175.

16: Elliott JT, Jiang S, Pogue BW, Gitajn IL. Bone-specific kinetic model to quantify periosteal and endosteal blood flow using indocyanine green in fluorescence guided orthopedic surgery. J Biophotonics. 2019 Aug;12(8):e201800427. doi: 10.1002/jbio.201800427. Epub 2019 May 8. PMID: 30963727; PMCID: PMC7331892.