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Silver Hydrofibrate versus collagenase curative in the control of venous ulcer infection: a randomized clinical trial

Hydrofiber with silver versus colagenase in the control of surface infection and biofilms of venous ulcers: randomized clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-4kkq2h
Enrollment
Unknown
Registered
2019-03-01
Start date
2019-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants will be the adult patients who were seen at the Chronic Ulcers Clinic of the Botucatu Medical School during the study period, presenting an age of 18 years or older, chronic venous ulcer (open ulcer over 6 weeks) with clinical signs of infection superficial.

Interventions

All 54 participants included in the study will undergo basal time (T0) to clean the ulcer with saline 0.9% and to the superficial surgical debridement of the bed of their ulcer (s). This procedure wil
Other

Sponsors

Faculdade de Medicina de Botucatu
Lead Sponsor
Faculdade de Medicina de Botucatu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Participants will be the adult patients who were seen at the Chronic Ulcers Clinic of the Faculty of Medicine of Botucatu during the study period, presenting an age of 18 years or older, chronic venous ulcer, open ulcer over 6 weeks, with clinical signs of infection superficial.

Exclusion criteria

Exclusion criteria: Ulcers of other etiologies (peripheral arterial disease, haematological causes, neoplastic, infectious, etc); Infected ulcers, that is, when associated with erysipelas, cellulitis or lymphangitis due to the need for systemic antibiotic therapy; Have a history of hypersensitivity to the treatments proposed. Have venous ulcer associated with peripheral arterial disease that will be characterized when the ankle-arm systolic index is less than 0.8 and / or absence of distal pulses, mainly tibial. Patients will be assessed clinically and with a script to characterize venous ulcer.

Design outcomes

Primary

MeasureTime frame
Rate of surface-infected ulcers (or critical colonization) according to the criteria of mnemonic rule NERDS in 30th day (T30); ;Rate of biofilm ulcers: evaluated in the 30th day (T30) by sonication methods and confocal electron microscopy.

Secondary

MeasureTime frame
Clinical improvement of the UV in the 30th day (T30) evaluated by the PUSH scale; ;Decreased ulcer area by planimetric method;;Rate of healing clinically evaluated at 30th day (T30) by observation of total epithelization without presence of crusts at the venous ulcer site.

Countries

Brazil

Contacts

Public ContactTaís Saranholi

Faculdade de Medicina de Botucatu

tais_saranholi@hotmail.com14997200079

Outcome results

None listed

Source: REBEC (via WHO ICTRP)