Clinical Implications of Biofilm in Chronic Wound

Summary

Chronic wounds are important economic and health-care problem. Biofilm has been recognized as a major factor in wound chronicity, delayed healing, and persistent infections, increasing the need for frequent dressing changes, painful debridement and systemic antimicrobial treatments influencing quality of life. In the presence of "un-cultivating" bacteria and limitations of clinical indicators of biofilm presence, there is a need for simple "screening" diagnostic method for biofilm detection. Chronic wounds of different etiology often associated with chronic pain reduce working abilities and cause restrictions in everyday living diminishing patient's quality of life. Efficacy of hyperbaric oxygenation therapy (HBOT) in treating chronic wound and associated infection has been suggested. This observational prospective cohort study will be conducted at the Department of undersea and hyperbaric medicine and Department of dermatovenereology, Clinical Hospital Center Rijeka during 3-year period from 2021. to 2024. including all patients treated due to chronic wound irrespective of the ethology. The patients will be evaluated upon enrolment, after 2, 4, 6 weeks, and 3, 6, 9, 12 months period, to clinically evaluate the wound characteristics, evaluate clinical healing rate, clinical indicators of biofilm and/or infection, need for additional diagnostic or treatment procedures. The patients in both groups (control and HBOT group) will be treated with standard treatment (dressings, debridement, antibiotics, infection control), in addition HBOT sessions will be performed (HBOT group). Impact of chronic wound and both treatment options to patient related outcome measures will be evaluated assessing intensity and pain characteristics, quality of life, depression, and anxiety by means of standardized questionnaires (visual analogue scale, McGill Pain questionnaire, Wound Quality of Life Index, Health Quality of Life Questionnaire, Beck depression and anxiety inventory). Microbiological analyses of swabs/biopsies will be evaluated to determine microbial profile and resistance. Detection and objectivization of biofilm will be evaluated by standard methods on microbiological isolates (Congo red agar, tube method, tissue culture plate method) and confocal scanning laser microscopy, and on clinical samples by light microscopy. Primary and secondary objective will be assessed after 1 year follow-up.

Conditions

• Wound
• Biofilm
• Chronic Pain
• Quality of Life
• Wound Healing

Interventions

OTHER

standard wound treatment

Standard treatment includes dressings, debridement, antibiotics, and bacterial load relief. The dressing will be performed according to wound characteristics with change every two days including primary dressing (alginates, hydrofiber dressing, antimicrobial dressing, gelling fiber dressing), with silver if infected, and secondary protective dressing (foam with polyurethane) in wounds with formed granulation tissue. The progression of the wound and the need for specific treatment will be evaluated weekly by dermatologist and vascular surgeon specializing in wound care, and appropriate treatment conducted according to wound assessment (antibiotics, bandage, dressing change, debridement, amputations).

PROCEDURE

Hyperbaric oxygenation (HBOT)

The HBOT sessions will be performed 5 days a week, in multi-place chamber at 2.4 atm absolute (ATA) and 100% O2 with effective treatment lasting for 90 min. The sessions will be supervised by doctors trained in hyperbaric medicine.

Sponsors & Collaborators

• University of Rijeka

  lead OTHER

Principal Investigators

• Tanja Batinac, M.D., PhD. · Department of undersea and hyperbaric medicine

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2022-12-31

Completion

2024-06-30

Countries

• Croatia

Study Locations