Lam Le1, Marc Baer2, Patrick Briggs3, Neal Bullock4, Windy Cole5, Daniel DiMarco6, Rachel Hamil7, Khristina Harrell8, Maria Kasper9, Weili Li10, Keyur Patel11, Matthew Sabo12, Kerry Thibodeaux13, Thomas E Serena8. 1. The Heal Clinic, Tulsa, Oklahoma, USA. 2. Foot & Ankle Center, Bryn Mawr, Pennsylvania, USA. 3. HCA-Houston Healthcare Gulf Coast Foot and Ankle Specialists, Webster, Texas, USA. 4. Royal Research Corp, Pembroke Pines, Florida, USA. 5. Kent State University College of Podiatric Medicine, Kent, Ohio, USA. 6. St. Vincent Wound & Hyperbaric Centre, Erie, Pennsylvania, USA. 7. St. Mary's Center for Wound Healing, Athens, Georgia, USA. 8. SerenaGroup Research Foundation, Cambridge, Massachusetts, USA. 9. Martin Foot and Ankle, York, Pennsylvania, USA. 10. Li & Li Statistical Consulting, Toronto, Canada. 11. Armstrong County Memorial Hospital, Kittanning, Pennsylvania, USA. 12. The Foot and Ankle Wellness Center of Western PA, Butler, Pennsylvania, USA. 13. The Wound Treatment Center at Opelousas General Health System, Opelousas, Louisiana, USA.
Abstract
Objective: High bacterial load contributes to chronicity of wounds and is diagnosed based on assessment of clinical signs and symptoms (CSS) of infection, but these characteristics are poor predictors of bacterial burden. Point-of-care fluorescence imaging (FL) MolecuLight i:X can improve identification of wounds with high bacterial burden (>104 colony-forming unit [CFU]/g). FL detects bacteria, whether planktonic or in biofilm, but does not distinguish between the two. In this study, diagnostic accuracy of FL was compared to CSS during routine wound assessment. Postassessment, clinicians were surveyed to assess impact of FL on treatment plan. Approach: A prospective multicenter controlled study was conducted by 20 study clinicians from 14 outpatient advanced wound care centers across the United States. Wounds underwent assessment for CSS followed by FL. Biopsies were collected to confirm total bacterial load. Three hundred fifty patients completed the study (138 diabetic foot ulcers, 106 venous leg ulcers, 60 surgical sites, 22 pressure ulcers, and 24 others). Results: Around 287/350 wounds (82%) had bacterial loads >104 CFU/g, and CSS missed detection of 85% of these wounds. FL significantly increased detection of bacteria (>104 CFU/g) by fourfold, and this was consistent across wound types (p < 0.001). Specificity of CSS+FL remained comparably high to CSS (p = 1.0). FL information modified treatment plans (69% of wounds), influenced wound bed preparation (85%), and improved overall patient care (90%) as reported by study clinicians. Innovation: This novel noncontact, handheld FL device provides immediate, objective information on presence, location, and load of bacteria at point of care. Conclusion: Use of FL facilitates adherence to clinical guidelines recommending prompt detection and removal of bacterial burden to reduce wound infection and facilitate healing.
Objective: High bacterial load contributes to chronicity of wounds and is diagnosed based on assessment of clinical signs and symptoms (CSS) of infection, but these characteristics are poor predictors of bacterial burden. Point-of-care fluorescence imaging (FL) MolecuLight i:X can improve identification of wounds with high bacterial burden (>104 colony-forming unit [CFU]/g). FL detects bacteria, whether planktonic or in biofilm, but does not distinguish between the two. In this study, diagnostic accuracy of FL was compared to CSS during routine wound assessment. Postassessment, clinicians were surveyed to assess impact of FL on treatment plan. Approach: A prospective multicenter controlled study was conducted by 20 study clinicians from 14 outpatient advanced wound care centers across the United States. Wounds underwent assessment for CSS followed by FL. Biopsies were collected to confirm total bacterial load. Three hundred fifty patients completed the study (138 diabetic foot ulcers, 106 venous leg ulcers, 60 surgical sites, 22 pressure ulcers, and 24 others). Results: Around 287/350 wounds (82%) had bacterial loads >104 CFU/g, and CSS missed detection of 85% of these wounds. FL significantly increased detection of bacteria (>104 CFU/g) by fourfold, and this was consistent across wound types (p < 0.001). Specificity of CSS+FL remained comparably high to CSS (p = 1.0). FL information modified treatment plans (69% of wounds), influenced wound bed preparation (85%), and improved overall patient care (90%) as reported by study clinicians. Innovation: This novel noncontact, handheld FL device provides immediate, objective information on presence, location, and load of bacteria at point of care. Conclusion: Use of FL facilitates adherence to clinical guidelines recommending prompt detection and removal of bacterial burden to reduce wound infection and facilitate healing.
Authors: Brady Hunt; Samuel S Streeter; Alberto J Ruiz; M Shane Chapman; Brian W Pogue Journal: Biomed Opt Express Date: 2021-10-19 Impact factor: 3.732
Authors: Elof Eriksson; Paul Y Liu; Gregory S Schultz; Manuela M Martins-Green; Rica Tanaka; Dot Weir; Lisa J Gould; David G Armstrong; Gary W Gibbons; Randy Wolcott; Oluyinka O Olutoye; Robert S Kirsner; Geoffrey C Gurtner Journal: Wound Repair Regen Date: 2022-02-07 Impact factor: 3.401
Authors: Kylie Sandy-Hodgetts; Charles A Andersen; Omar Al-Jalodi; Laura Serena; Christina Teimouri; Thomas E Serena Journal: Int Wound J Date: 2021-12-27 Impact factor: 3.099