In a significant advancement aimed at enhancing surgical safety, researchers have developed a novel fluorescent gauze that can help surgeons accurately identify and retrieve lost gauze during operations. This innovative solution, which utilizes the fluorescent properties of indocyanine green (ICG), promises to minimize the incidents of retained surgical items, a problem infrequently acknowledged yet impactful.
Retained surgical sponges, often referred to as gossypiboma, pose serious health risks to patients and complicate surgical procedures. The incidence of these occurrences varies widely, from as low as 1 in 8,801 to as high as 1 in 18,760 inpatient surgeries. Despite the introduction of radiopaque markers and rigorous counting protocols, these incidents remain a challenge. "This gauze should be manufactured for clinical use and its usefulness should be validated," wrote the authors of the article, underscoring the need for practical applications.
The researchers, operating at the Medical Device Innovation Platform, created the fluorescent gauze by dissolving 25 mg of ICG in a solution consisting of glycerol, ethanol, distilled water, and 5% bovine serum albumin. Each solution was then diluted from 5- to 106-fold with distilled water to produce an effective dye for the gauze. Remarkably, it was found that gauze treated with a 100-fold dilution of the ICG solution exhibited the strongest fluorescence effects.
To assess the performance of the fluorescent gauze, both ex vivo and in vivo tests were conducted, involving a 38 kg female pig as the surgical model. Under near-infrared (NIR) imaging conditions, the gauze's fluorescence was observed clearly within the pig's abdominal cavity, with the ability to penetrate through two to three layers of the mesentery.
The study detailed that the mean fluorescence intensity (FI) values for the gauze samples examined in vivo were notably robust, averaging around 253 for those dyed with diluted solutions of glycerol and ethanol under normal surgical conditions. However, this intensity showed a decrease after blood absorption, indicating that while the gauze performs effectively during operations, further optimization may be necessary.
Of particular note is the gauze's capacity to maintain its fluorescent properties over an extended period. The study highlighted that fluorescent gauze dyed with a 100-fold diluted pure ICG solution was able to retain a stable fluorescence intensity for over three years, a promising factor for its practical application in clinical settings.
Current approaches to surgical gauze often fall short, largely due to challenges in visibility and retrieval methods, especially during laparoscopic surgeries. By employing ICG as an innovative agent, surgeons can improve their intraoperative strategies. The introduction of fluorescence into gauze not only highlights its presence but also allows for reduced reliance on time-consuming and radiation-heavy methods of gauze retrieval.
The findings from this study come at a time when advancements in surgical technologies are increasingly important. With the adoption of ICG fluorescence-guided surgery already becoming mainstream in various medical fields, the implications of this development are far-reaching. Surgeons could significantly reduce the risk and stress associated with retained surgical items while enhancing overall patient safety.
While the study presents promising results, it also acknowledges certain limitations inherent to prototype development. The optimal concentrations for dye solutions remain to be determined, and further studies are essential to validate the safety and effectiveness of the fluorescent gauze across different surgical procedures.
As the medical community continues to confront the issue of retained surgical sponges, the fluorescent gauze has the potential to redefine how surgeons operate under fluorescence-guided conditions, aligning with best practices and accountability in surgical care. Additional validation is needed before these products can become a routine part of surgical kits, but the groundwork laid by this research opens a new frontier in enhancing patient safety.