Clinical Implications of Biofilm in Chronic Wound
Unknown statusNCT05054244
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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). Microbiolo…
Study details
- Official title
- Biofilm in Chronic Wound - Clinical Implications and Diagnostic Possibilities
- Conditions
- Wound
- Biofilm
- Chronic Pain
- Quality of Life
- Wound Healing
- Interventions
- Other: standard wound treatment
- Procedure: Hyperbaric oxygenation (HBOT)
- Sponsor
- University of Rijeka
- Start date
- 2021-07-01
- Primary completion
- 2022-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Croatia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * all patients with chronic wound * chronic wound irrespective of the ethology (arterial, diabetic, venous, decubital, combined etiology, posttraumatic, postamputation, burn, and other) * 18 years of age and older * signed informed consent Exclusion criteria: • failure to meet one of the inclusion criteria Exclusion criteria from HBOT group: * patients with absolute or relative contraindications for HBOT * patients on bleomycin chemotherapy * patients with chronic obstructive pulmonary disease, previous spontaneous pneumothorax, chronic otitis media or chronic sinusitis, unstable angina pectoris, severe heart failure, severe dementia, history of seizures, claustrophobia * patients with significant macroangiopathy and absent both distal pulses and no positive response following oxygen provocation test on transcutaneous oximetry
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05054244