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Comparative study between Topical Coverages on critically colonized or infected wounds in patients with Pressure Injury

Comparative study between Topical Coatings of Dialkyl Carbamoyl Chloride vs Polyamide with Silver

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9396ksd
Enrollment
Unknown
Registered
2024-10-08
Start date
2024-03-29
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

Pressure Ulcer

Interventions

This is a prospective, randomized and controlled study on patients hospitalized at the Instituto Central do Hospital das Clínicas (ICHC) patients with Grades 3 and 4 pressure injuries will be randomiz

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Both sexes; patients aged between 18 and 80 years; pressure injuries requiring surgery (Grades 3 or 4); presence of critical colonization (positive tissue culture) or infection of wound (clinical and laboratory signs of infection); care by the Plastic Surgery Complex Wounds Group

Exclusion criteria

Exclusion criteria: Pressure injuries without surgical indication (Grades 1 or 2); presence of uncontrolled systemic disease; failure to collect intraoperative cultures; patients with BMI>35; patients with diseases that compromise immunity; allergy to silver or dialkyl carbamoyl chloride acetate; non-agreement to participate in the study and/or sign the informed consent form; change of conduct; loss of follow-up

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of the DACC dressing versus Polyamide with silver in critically colonized or infected wounds in patients hospitalized with Grades 3 and 4 Pressure Injuries

Secondary

MeasureTime frame
Identify the bacterial flora in the wound, verify the reduction in the bacterial load in the wound throughout treatment and measure the length of stay of the patients studied.

Countries

Brazil

Contacts

Public ContactRafael Adailton Junior

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

rafaeljunior96@hotmail.com+55-11-952806096

Outcome results

None listed

Source: REBEC (via WHO ICTRP)