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The Wound action effects of a Simple Suction Dressing

A Simplifield Vacuum Dressing System: a Randomised Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5c8y6v
Enrollment
Unknown
Registered
2019-06-04
Start date
2017-04-01
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

Wounds and Injuries. Wound Healing

Interventions

Experimental group: 25 dirty and/or contaminated wounds belonging to 25 different hospitalized patients were treated with an alternative negative pressure therapy device (Simplifield Vacuum Dressing S
Device
Procedure/surgery

Sponsors

Hospital Geral Roberto Santos
Lead Sponsor
Instituto de Ciências da Saúde da Universidade Federal da Bahia
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Healthy volunteers; persons hospitalized at the reference unit (General Hospital Roberto Santos), both genders; age greater than 18; contaminated and / or dirty wounds that are not responding in terms of cleaning to usual dressings (eg gauze, antibiotic ointments)

Exclusion criteria

Exclusion criteria: Diagnosis of decompensated or severe systemic disordens (cardiac, renal, gastrointestinal, hepatic, pulmonary, neurological, psychiatric, hematological or metabolic, morbid obesity, severe anemia, hemodynamic instability); previous use of one of the dressings studied; untreated infection or infection with systemic repercussion; unfavorable wounds(perilesional dermatoses, wounds associated with fistulas, malignant neoplasm of the wound, wounds with exposure of vessels, nerves or viscera, periorificial wounds); use of immunosuppressants

Design outcomes

Primary

MeasureTime frame
Measure the development of clean and healthy-looking granulation tissue present in the treated wounds through the (blind) evaluation of digital photographs at the beginning of the study and at the end of the study, based on a variation of at least 80% in measurements pre and post intervention

Secondary

MeasureTime frame
To determine the index of complications and adverse effects resulting from the use of the dressings studied, determined through direct clinical observation of the onset of pain, infection, necrosis, maceration, bleeding and allergic reactions

Countries

Brazil

Contacts

Public ContactFabiana Paim

Instituto de Ciências da Saúde da Universidade Federal da Bahia

ics@ufba.br+55 (71) 3283-8885

Outcome results

None listed

Source: REBEC (via WHO ICTRP)