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Exploring alternative wound care treatment for percutaneous gastrostomy site infection: A prospective, randomized, open, blinded end-point (PROBE) design.

Exploring alternative wound care treatment for percutaneous gastrostomy site infection: A prospective, randomized, open, blinded end-point (PROBE) design.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23605
Enrollment
30
Registered
2010-12-27
Start date
2011-02-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

PEG-site infections Infectie van de PEG-insteekopening

Interventions

Group 1: Standard treatment with local antibiotic ointment (Fucidin ointment)
Group 2: Treatment with silver-impregnated dressing (Atrauman AG).

Sponsors

VU Medical Center, Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Signed informed consent; 2. PEG-site infection graded as type 1 & 2 (1= early signs of inflammation,proactive measures, 2= Requiring local antiseptic/antibiotic care); 3. Male and female participants age 18 and older; 4. PEG insertion procedure longer than 1 week prior to randomization; 5. Patient or guardian is able to fully comprehend and perform study procedures.

Exclusion criteria

Exclusion criteria: 1. Estimated life expectancy less than one month; 2. Concurrent use of oral antibiotics for other diagnosis; 3. Signs and symptoms of concurrent disease for which the subject is expected to start antibiotic treatment.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the reduction or increase in peristomal sepsis scoring in both groups using the scoring scale of Jain et al.

Secondary

MeasureTime frame
1. The number of patients in which the PEG - site infection was regarded as healed; 2. Percentage decrease in number of bacterial species as measured by the IS-pro; 3. Treatment related adverse events; 4. Recurrence of infection 1 week after healing; 5. Deterioration of the infection-site that will require withdrawal.

Contacts

Public ContactEsmé Clasquin

De Boelelaan 1118

mdl.research@vumc.nl+31 (0)20 4449455

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)