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

Percutaneous endoscopic gastrostomy (PEG) feeding tubes are increasingly used
for patients who require medium to longer term nutritional support due to
inadequate oral intake. Main indications for insertion are neurological
conditions and head and neck malignancies.

There is little doubt about the role of antibiotic prophylaxis to prevent early
PEG- wound infections directly before or after placement. However, insertion
site infection is the complication most seen in the later stage (longer than 72
hours after insertion) after PEG-placement and reported incidences vary from 5
up to 32%. In a literature search conducted on National Guideline
Clearinghouse, Medline and CINAHL no guidelines or evidence as to the
management of the (later) infected percutaneous site, nor the role of topical
antiseptics or antibiotics to treat these infections were found. Thus, one can
conclude that treatment protocols vary in different health-care settings.

Even though infections of PEG-sites have to be addressed promptly to avoid
problems with PEG maintenance or a systemic infection, recommendations for the
use of topical antibiotics are changing due to increasing antimicrobial
resistance and its amplification.

At the Gastroenterology department of the VU medical center of Amsterdam (VUmc)
follow-up care after PEG-placement is provided by a team of three specialized
nurses and a supervising physician. Infectious complications are assessed and
the degree of infection is defined as: 1. early signs of inflammation=proactive
measures, 2. requiring local antiseptic/antibiotic care, 3. requiring systemic
antibiotics and 4. requiring surgery or PEG-tube removal.
For a infectious complication grade 2, the nurses currently prescribe a topical
antibiotic treatment under the supervision of the attending medical staff.
Fusidic acid and more recently, erythromycin were the topical antibiotics most
prescribed by the nurses and medical staff.

Antiseptic use instead of antibiotics may therefore be a preferable alternative
treatment of PEG site infections with regard to bacterial resistance.
The newer type of antiseptic dressings containing nanocrystalline or coated
with elemental silver have been designed considering these arguments and are
not regarded as harmful.
A systematic review done in 2007 on topical silver dressings concluded that
there is little evidence to support the use of silver dressings due to lack of
reliable data. The authors argued that the conduct of further appropriate
randomized controlled trials are important to guide future decisions on the use
of silver-containing dressings in clinical use. Therefore, we propose to
compare the current treatment of topical antibiotics with the treatment of the
improved silver-impregnated dressings in a randomized, open-label trial.

Primary Objective:
* To determine the efficacy of silver impregnated dressings compared to a
topical antibiotic to treat patients with PEG-site infections.

Secondary Objectives:

* To investigate the reduction and or change in stomal bacterial profile in the
different treatment groups.

* Comparison of pain reduction of the different treatments as measured on a
linear visual analogue scale (VAS).

* To investigate recurrence of infection after one week, in both treatments,
after healing has occurred.

* To investigate which treatment requires withdrawal of patients from treatment
due to no response to treatment or the affected area increasing in size.

* To investigate the ease of use of treatments as experienced by the patient.

The study is designed as a prospective, randomized open-label trial (PROBE *
design).

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

The participants will be burdened with spending a longer periods of time at the
hospital ( 60 minutes in total) Vital signs will be recorden twice, and the
patient will be phoned at home twice. There are no benefits or extreme risks
for the participating subjects.