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

Exploring alternative wound care treatment for percutanous gastrostomy site infection: a prospective, randomized, open, blinded end-point (PROBE) design. - PEG-protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36555

Enrollment

Registered

2011-03-29

Start date

2011-04-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

stomal infection/ tube infection

Interventions

Subjects will be randomized in a 1:1 ratio to 2 weeks of treatment of either topical antibiotic treatment or silver-impregnated dressing treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Signed informed consent PEG-site infection graded as type 1 (early signs of inflammation

Exclusion criteria

Exclusion criteria: Estimated life expectancy less than one month Concurrent use of oral antibiotics for other diagnosis Signs and symptoms of concurrent disease for which the subject is expected to start antibiotic treatment PEG-site infection graded as type 3 (requiring systemic antibiotics ) & 4 (requiring surgery or PEG-tube removal)

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the reduction or increase in peristomal sepsis scoring in both groups as evaluated by the blinded assessor using the validated scoring scale of Jain et al.	—

Secondary

Measure	Time frame
* The number of patients in which the PEG site infection was regarded as healed after two weeks of treatment. Healing is defined as no sign and symptoms of infection such as erythema, induration , purulent discharge and skin closure as confirmed by the blinded assessor. * Percentage decrease in number of bacterial species as measured by the IS-pro method. * Treatment related adverse events * Recurrence of infection 1 week after healing * Deterioration of the infection-site that will require withdrawal	—

Measure

Time frame

* The number of patients in which the PEG site infection was regarded as healed after two weeks of treatment. Healing is defined as no sign and symptoms of infection such as erythema, induration , purulent discharge and skin closure as confirmed by the blinded assessor. * Percentage decrease in number of bacterial species as measured by the IS-pro method. * Treatment related adverse events * Recurrence of infection 1 week after healing * Deterioration of the infection-site that will require withdrawal

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)