慢性傷口不僅影響患者生活品質，更佔據大量醫療支出為現今全球健康照護極為棘手的挑戰。近年國際研究揭示了造成慢性傷口的罪魁禍首為傷口表面之細菌生物膜。這項發現衍生「以生物膜導向之傷口照護」之概念，大大改變現今傷口照護之指引，但在臨床上，卻缺乏可靠簡便的傷口生物膜檢測工具。
有鑒於此，本團隊匯聚了清華大學生物醫學工程研究所在醫學檢測上的專業與台大整形外科的傷口專家經驗，共同研發「傷口細菌生物膜感染檢測系統」，此一突破性產品操作簡單迅速，只需將檢測試片貼附於傷口，再對其進行染色分析，短短幾分鐘即可準確判讀傷口是否感染細菌生物膜，並確定感染的嚴重度。
這項檢測技術具備快速、精準且成本低廉之優勢。同時已有體外試驗、動物試驗、及小規模臨床試驗之證據支持。醫師將能藉此技術預測傷口癒合時間，並可輔助決策是否需施行清創手術等抗生物膜治療。同時，透過試片拓印，更可提供生物膜在傷口中的分布情況和嚴重程度，從而達到精準治療的目的。
同時，本團隊亦針對可能與傷口不癒合相關之臨床風險因子以及慢性傷口微環境中之促炎性細胞激素進行分析研究，從中篩選出與傷口癒合不良具有顯著相關之生物標誌，合併本團隊開發之傷口細菌生物膜感染檢測結果可以達到93.75%正確預測傷口預後之能力。
本團隊期許藉由此技術之問世與推廣，能改變過去因缺乏適切傷口生物膜檢測工具而使專家們只能憑猜測採用以生物膜導向之傷口照護治療策略。進而建立傷口生物膜感染診斷與治療的標準流程，為慢性傷口患者帶來新希望。

Chronic wounds pose an immense challenge in today's global healthcare landscape. They not only affect patients' quality of life but also account for a substantial portion of medical expenditures. Recent international research has revealed the chief culprit behind these hard-to-heal wounds - bacterial biofilm at the wound surface. This discovery has led to a paradigm shift in wound care, emphasizing "biofilm-based wound care." However, in clinical practice, there remains a lack of reliable and convenient wound biofilm detection tools.
In light of this, our team has brought together the plastic surgeons dedicated in chronic wound research from Division of Plastic Surgery at NTUH and the researchers experienced in developing point-of-care tests from the Institute of Biomedical Engineering at National Tsing Hua University. Together, we have developed the "Wound Biofilm Rapid Detection Kit," a groundbreaking product that offers a simple and swift procedure. By applying a specially designed transfer membrane to the wound surface and subsequently conducting a staining analysis, within three minutes, clinicians can accurately detect bacterial biofilm over the wounds and assess the severity of the biofilm infection if it is present.
This detection tool exhibits the advantages of speed, precision, and cost-effectiveness. Moreover, it has shown promising results in animal models, in vitro, and in preliminary small-scale clinical trials. Clinicians can use this tool to predict wound healing time accurately and make informed decisions about interventions, such as implementing debridement or anti-biofilm therapies. Additionally, the wound blotting technique provides valuable information about the distribution and severity of the biofilm within a wound, thus facilitating more precise treatment strategies.
Meanwhile, our team also conducts analyses on potential clinical risk factors associated with non-healing wounds and pro-inflammatory cytokines in the microenvironment of chronic wounds. Through this research, we identify significant biomarkers correlated with poor wound healing. Combining these findings with the wound blotting biofilm infection detection results developed by our team, we achieve a 93.75% accuracy in predicting wound prognosis.
Our team expect that the introduction and promotion of this technology will revolutionize wound care practices. It will eliminate the previous trial-and-error approach, where experts resorted to clinical suspicion of biofilm due to the lack of appropriate wound biofilm detection tools. This technology will set up a standardized protocol of wound biofilm diagnosis and treatment, thus brings new hope to chronic wound patients.

中文摘要 2
Abstract 4
目錄 6
圖目錄 8
表目錄 10
第一章 緒論 11
1.1 慢性傷口定義與其重要性 11
1.2 傷口細菌生物膜之生成 13
1.3 生物膜感染與慢性傷口之關係 14
1.4 傷口生物膜感染的治療方法 16
1.5 傷口生物膜檢測技術 17
1.6 傷口生物膜感染檢測套組之開發 20
1.7 慢性傷口生物膜之動物模型 22
1.8 生物膜感染之慢性傷口治療方法 24
1.9 傷口微環境之檢測分析 25
1.10 C反應蛋白(C-reactive protein, CRP)與慢性傷口之關聯性 28
第二章 傷口生物膜檢測體外模型與動物模型 30
2.1 體外生物膜模型之建立 30
2.2 傷口生物膜感染檢測流程最佳化：體外試驗 33
2.3 傷口生物膜感染檢測驗證：動物模型 40

第三章 傷口生物膜檢測臨床驗證 53
3.1 與臨床傷口組織細菌培養及傷口預後驗證 53
3.2 檢測分級驗證，及與MolecuLight i:X檢測之臨床比較驗證 56
第四章 傷口微環境之檢測分析 64
4.1 傷口局部細胞激素與傷口癒合預後之關聯性分析 64
4.2 傷口CRP與全身性CRP與傷口癒合預後之分析 72
4.3 傷口癒合時間預測模型之建立與分析 80
第五章 結論與未來規劃 84
5.1 結論 84
5.2 未來展望 89
第六章 參考文獻 92

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