A Diagnostic-Driven Prospective Clinical Study Evaluating the Combination of an Antibiofilm Agent and Negative Pressure Wound Therapy
<p>Biofilm-disrupting gel on negative pressure sponge dressing.</p> "> Figure 2
<p>Mean wound surface area reduction divided by groups.</p> "> Figure 3
<p>Mean wound surface area reduction comparison between overall and responder groups.</p> "> Figure 4
<p>Percentage of patients with positive host matrix metalloprotease (MMP) activity within.</p> "> Figure 5
<p>An example of bacterial fluorescence at the time of enrollment after failed negative pressure. (<b>A</b>) Standard image. (<b>B</b>) Fluorescence image with extensive bacterial fluorescence. (<b>C</b>) Reduction in ulcer surface area and marked reduction in bacterial fluorescence at 4 weeks.</p> ">
Abstract
:1. Introduction
2. Materials and Methods
3. Results
- Primary Endpoint (wound size):
- Secondary Endpoints:
4. Discussion
5. Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Afzali Borojeny, L.; Albatineh, A.N.; Hasanpour Dehkordi, A.; Ghanei Gheshlagh, R. The Incidence of Pressure Ulcers and its Associations in Different Wards of the Hospital: A Systematic Review and Meta-Analysis. Int. J. Prev. Med. 2020, 11, 171. [Google Scholar]
- Sheehan, P.; Jones, P.; Caselli, A.; Giurini, J.M.; Veves, A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Diabetes Care 2003, 26, 1879–1882. [Google Scholar] [CrossRef]
- Mervis, J.S.; Phillips, T.J. Pressure ulcers: Prevention and management. J. Am. Acad. Dermatol. 2019, 81, 893–902. [Google Scholar] [CrossRef] [PubMed]
- Jaul, E.; Barron, J.; Rosenzweig, J.P.; Menczel, J. An overview of co-morbidities and the development of pressure ulcers among older adults. BMC Geriatr. 2018, 18, 305. [Google Scholar] [CrossRef] [PubMed]
- Halim, A.S.; Khoo, T.L.; Saad, A.Z. Wound bed preparation from a clinical perspective. Indian J. Plast. Surg. 2012, 45, 193–202. [Google Scholar] [CrossRef] [PubMed]
- Le, L.; Baer, M.; Briggs, P.; Bullock, N.; Cole, W.; DiMarco, D.; Hamil, R.; Harrell, K.; Kasper, M.; Li, W.; et al. Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial. Adv. Wound Care 2021, 10, 123–136. [Google Scholar] [CrossRef]
- Wolcott, R.D.; Rhoads, D.D. A study of biofilm-based wound management in subjects with critical limb ischaemia. J. Wound Care 2008, 17, 145–148+150–152+154–155. [Google Scholar] [CrossRef]
- Costerton, J.W.; Stewart, P.S.; Greenberg, E.P. Bacterial biofilms: A common cause of persistent infections. Science 1999, 284, 1318–1322. [Google Scholar] [CrossRef] [PubMed]
- Ammons, M.C.; Ward, L.S.; James, G.A. Antibiofilm efficacy of a lactoferrin/xylitol wound hydrogel used in combination with silver wound dressings. Int. Wound J. 2011, 8, 268–273. [Google Scholar] [CrossRef]
- Werdin, F.; Tenenhaus, M.; Rennekampff, H.O. Chronic wound care. Lancet 2008, 372, 1860–1862. [Google Scholar] [CrossRef]
- Wolcott, R. Disrupting the biofilm matrix improves wound healing outcomes. J. Wound Care 2015, 24, 366–371. [Google Scholar] [CrossRef] [PubMed]
- Miller, K.G.; Tran, P.L.; Haley, C.L.; Kruzek, C.; Colmer-Hamood, J.A.; Myntti, M.; Hamood, A.N. Next science wound gel technology, a novel agent that inhibits biofilm development by gram-positive and gram-negative wound pathogens. Antimicrob. Agents Chemother. 2014, 58, 3060–3072. [Google Scholar] [CrossRef]
- Serena, T.E.; Jalodi, O.; Serena, L.; Patel, K.; Myntti, M. Evaluation of the combination of a biofilm-disrupting agent and negative pressure wound therapy: A case series. J. Wound Care 2021, 30, 9–14. [Google Scholar] [CrossRef] [PubMed]
- Ruggiano, N.; Perry, T.E. Conducting secondary analysis of qualitative data: Should we, can we, and how? Qual. Soc. Work. 2019, 18, 81–97. [Google Scholar] [CrossRef] [PubMed]
- Agency for Healthcare Research and Quality. Preventing Pressure Ulcers in Hospitals. 2014. Available online: https://www.ahrq.gov/patient-safety/settings/hospital/resource/pressureulcer/tool/pu1.html (accessed on 1 June 2020).
- Reddy, M.; Gill, S.S.; Kalkar, S.R.; Wu, W.; Anderson, P.J.; Rochon, P.A. Treatment of pressure ulcers: A systematic review. JAMA 2008, 300, 2647–2662. [Google Scholar] [CrossRef] [PubMed]
- Bauer, K.; Rock, K.; Nazzal, M.; Jones, O.; Qu, W. Pressure ulcers in the United States’ inpatient population from 2008 to 2012: Results of a retrospective nationwide study. Ostomy Wound Manag. 2016, 62, 30–38. [Google Scholar]
- Malone, M.; Bjarnsholt, T.; McBain, A.J.; James, G.A.; Stoodley, P.; Leaper, D.; Tachi, M.; Schultz, G.; Swanson, T.; Wolcott, R.D. The prevalence of biofilms in chronic wounds: A systematic review and meta-analysis of published data. J. Wound Care 2017, 26, 20–25. [Google Scholar] [CrossRef] [PubMed]
- Brem, H.; Maggi, J.; Nierman, D.; Rolnitzky, L.; Bell, D.; Rennert, R.; Golinko, M.; Yan, A.; Lyder, C.; Vladeck, B. High cost of stage IV pressure ulcers. Am. J. Surg. 2010, 200, 473–477. [Google Scholar] [CrossRef] [PubMed]
- Song, Y.P.; Wang, L.; Yuan, B.F.; Shen, H.W.; Du, L.; Cai, J.Y.; Chen, H.L. Negative pressure wound therapy for III/IV pressure injuries: A meta-analysis. Wound Repair Regen. 2021, 29, 20–33. [Google Scholar] [CrossRef]
- Andersen, C.A.; McLeod, K.; Steffan, R.; Serena, T.E. Underappreciated bacterial burden in pressure ulcers: Clinical trial and real-world evidence. J. Wound Manag. 2023, 24, 80. [Google Scholar]
- Goss, S.G.; Schwartz, J.A.; Facchin, F.; Avdagic, E.; Gendics, C.; Lantis, J.C., 2nd. Negative Pressure Wound Therapy with Instillation (NPWTi) Reduces Post-debridement Bioburden in Chronically Infected Lower Extremity Wounds Than NPWT Alone. J. Am. Coll. Clin. Wound Spec. 2014, 4, 74–80. [Google Scholar] [CrossRef] [PubMed]
- Gabriel, A.; Shores, J.; Heinrich, C.; Baqai, W.; Kalina, S.; Sogioka, N.; Gupta, S. Negative pressure wound therapy with instillation: A pilot study describing a new method for treating infected wounds. Int. Wound J. 2008, 5, 399–413. [Google Scholar] [CrossRef] [PubMed]
- Kim, P.J.; Attinger, C.E.; Steinberg, J.S.; Evans, K.K.; Lehner, B.; Willy, C.; Lavery, L.; Wolvos, T.; Orgill, D.; Ennis, W.; et al. Negative-pressure wound therapy with instillation: International consensus guidelines. Plast. Reconstr. Surg. 2013, 132, 1569–1579. [Google Scholar] [CrossRef]
- Gupta, S.; Gabriel, A.; Lantis, J.; Téot, L. Clinical recommendations and practical guide for negative pressure wound therapy with instillation. Int. Wound J. 2016, 13, 159–174. [Google Scholar] [CrossRef] [PubMed]
- Vellingiri, K.; Nagakumar, J.S.; Hongaiah, D. Negative Pressure Wound Therapy with Flap Reconstruction for Extensive Soft Tissue Loss in the Foot: A Case Report. Cureus 2020, 12, e10116. [Google Scholar] [CrossRef]
- Serena, T.E.; Cullen, B.M.; Bayliff, S.W.; Gibson, M.C.; Carter, M.J.; Chen, L.; Yaakov, R.A.; Samies, J.; Sabo, M.; DeMarco, D.; et al. Defining a New Diagnostic Assessment Parameter for Wound Care: Elevated Protease Activity, an Indicator of Nonhealing, for Targeted Protease-modulating Treatment. Wound Repair. Regen. 2016, 24, 589–595. [Google Scholar] [CrossRef]
Patient | Age (Years) | Gender | Ulcer Duration (Weeks) | Mini Nutritional Assessment Score | Comorbidities (Major Conditions Listed) |
---|---|---|---|---|---|
1 | 67 | Female | 48 | 7 | Type 2 diabetes, multiple traumas following a motor vehicle accident with paraplegia, permanent colostomy, hypothyroidism, anemia of chronic disease |
2 | 70 | Female | 156 | 7 | Multiple sclerosis with generalized weakness, recent bilateral hip fractures, overactive bladder |
3 | 70 | Male | 68 | 8 | Multiple sclerosis with generalized weakness, wheelchair-bound, obesity |
4 | 46 | - | 58 | 9 | - |
5 | 59 | Female | 20 | 11 | Right above-knee amputation, chronic general body pain |
6 | 22 | Male | 60 | 12 | Paraplegia, muscle spasticity, anemia of chronic disease, neuropathy |
7 | 67 | Female | 52 | 13 | Diabetes, multiple traumas following motor vehicle accident, paraplegia, history of perforated bowel with ileostomy, history of deep venous thrombosis with caval filter hypothyroidism, anemia of chronic disease |
8 | 67 | Male | 8 | 10 | Paraplegia following motor vehicle accident |
9 | 78 | Female | 104 | - | Diabetes, peripheral arterial disease, chronic obstructive pulmonary disease, dysphagia, encephalopathy |
10 | 66 | Female | 36 | 8 | Generalized weakness, dysphagia, coronary artery disease, hypertension, incontinence, schizoaffective disorder, lower extremity contractures, seizure disorder |
11 | 70 | Female | 4 | 14 | Type 2 diabetes, hyperlipidemia, hypothyroidism, hypertension, left breast cancer (resolved) |
12 | 57 | Female | 13 | 14 | Type 2 diabetes, hyperlipidemia, hypertension, obesity, depression |
13 | 80 | Female | 7 | 6 | Hypokalemia, chronic general body pain, constipation |
14 | 68 | Male | 52 | 11 | Hypertension, paraplegia, broken back (4 occasions), chronic general body pain, chronic migraines |
15 | 70 | Male | >52 | 10 | Type 2 diabetes, peripheral vascular disease, lymphedema, hypertension, spinal stenosis, neuropathy, anxiety |
16 | 82 | Male | 12 | 11 | Incontinence, appendectomy, cholecystectomy, back surgery |
17 | 69 | Male | 9 | 12 | Multiple sclerosis, epilepsy, hyperlipidemia, osteoarthritis, vitamin D deficiency, vitamin B12 deficiency |
18 | 82 | Male | 4 | 10 | Type 2 diabetes, atrial fibrillation, hypertension, hypothyroidism, chronic general body pain, iron deficiency anemia |
19 | 49 | Female | 208 | 12 | Type 2 diabetes, paraplegic, hypercholesterolemia, hypertension, multiple back surgeries, urostomy ileal conduit |
20 | 71 | Male | 8 | 7 | Chronic atrial fibrillation, hypertension, benign prostatic hyperplasia, gastroesophageal reflux disease, obesity, depression, COVID-19 |
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Serena, T.E.; King, E.; Serena, L.; Breisinger, K.; Al-Jalodi, O.; Myntti, M.F. A Diagnostic-Driven Prospective Clinical Study Evaluating the Combination of an Antibiofilm Agent and Negative Pressure Wound Therapy. Diagnostics 2024, 14, 774. https://doi.org/10.3390/diagnostics14070774
Serena TE, King E, Serena L, Breisinger K, Al-Jalodi O, Myntti MF. A Diagnostic-Driven Prospective Clinical Study Evaluating the Combination of an Antibiofilm Agent and Negative Pressure Wound Therapy. Diagnostics. 2024; 14(7):774. https://doi.org/10.3390/diagnostics14070774
Chicago/Turabian StyleSerena, Thomas E., Emily King, Laura Serena, Kristy Breisinger, Omar Al-Jalodi, and Matthew F. Myntti. 2024. "A Diagnostic-Driven Prospective Clinical Study Evaluating the Combination of an Antibiofilm Agent and Negative Pressure Wound Therapy" Diagnostics 14, no. 7: 774. https://doi.org/10.3390/diagnostics14070774
APA StyleSerena, T. E., King, E., Serena, L., Breisinger, K., Al-Jalodi, O., & Myntti, M. F. (2024). A Diagnostic-Driven Prospective Clinical Study Evaluating the Combination of an Antibiofilm Agent and Negative Pressure Wound Therapy. Diagnostics, 14(7), 774. https://doi.org/10.3390/diagnostics14070774