Prospective, randomised, double blind trial of prophylaxis with single dose of co-amoxiclav before percutaneous endoscopic gastrostomy

BMJ 1999;319:881 ( 2 October )

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Prospective, randomised, double blind trial of prophylaxis with single dose of co-amoxiclav before percutaneous endoscopic gastrostomy

G Preclik, associate professor, ^a S Grüne, associate physician, ^b H G Leser, associate professor, ^c J Lebherz, associate physician, ^c W Heldwein, associate professor, ^d K Machka, director, anti-infective clinical research, ^e A Holstege, associate professor, ^b W V Kern, associate professor. ^a

^a Medizinische Universitätsklinik und Poliklinik, D-89070 Ulm, Germany, ^b Klinik und Poliklinik für Innere Medizin I, Klinikum der Universität Regensburg, D-93042 Regensburg, Germany, ^c Kreiskrankenhaus Böblingen, D-71032 Böblingen, Germany, ^d Ludwig-Maximilians-Universität, Innere Medizin/Endoskopie, D-80366 München, Germany, ^e SmithKline Beecham Pharma, D-80804 München, Germany

Correspondence to: Dr Kern winfried.kern{at}medizin.uni-ulm.de

Objective: To determine the efficacy of antibacterialprophylaxis in preventing infectious complications after percutaneousendoscopicgastrostomy.
Design: Prospective, randomised, placebo controlled,double blind, multicentrestudy.
Setting: Departments of internal medicine at six Germanhospitals.
Subjects: Of 106 randomised adult patients with dysphagia,97 received study medication, and 84 completed the study. Themedian age of the patients was 65 years. Most had dysphagia dueto malignant disease (65%), and many (76%) had seriouscomorbidity.
Interventions: A single intravenous 2.2 g dose of co-amoxiclavor identical appearing saline was given 30 min before percutaneousendoscopic gastrostomy performed by the thread pullmethod.
Main outcome measures: Occurrence of peristomal wound infectionsand other infections within one week after percutaneous endoscopicgastrostomy.
Results: The incidence of peristomal and other infectionswithin one week after percutaneous endoscopic gastrostomy wassignificantly reduced in the antibiotic group (8/41 (20%) v 28/43(65%), P<0.001). Similar results were obtained in an intentionto treat analysis. Several peristomal wound infections were ofminor clinical significance. After wound infections that requiredno or only local treatment were excluded from the analysis, antibioticprophylaxis remained highly effective in reducing clinically importantwound infections (1/41 (2%) v 11/43 (26%), P<0.01) and non-woundinfections (2 (5%) v 9 (21%), P<0.05).
Conclusions: Antibiotic prophylaxis with a single doseof co-amoxiclav significantly reduces the risk of infectious complicationsafter percutaneous endoscopic gastrostomy and should berecommended.

Key messages

Percutaneous endoscopic gastrostomy for enteral feeding can be associated with substantial rates of infectious complications, notably peristomal wound infection
Small, single centre studies on prevention of wound infection by antibiotic prophylaxis have given conflicting results
This prospective, randomised, placebo controlled, double blind, multicentre study showed that a single dose of 2.2 g co-amoxiclav significantly reduced the rate of infection
The favourable effect of antibiotic prophylaxis included a reduction in the rate of clinically important peristomal wound infection
Intention to treat analysis indicated a significant reduction in the need for therapeutic antibiotics

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Rapid Responses:

Read all Rapid Responses

Objectivity required?: David Carvel
bmj.com, 5 Oct 1999 [Full text]
Re: Objectivity required?: Winfried V Kern
bmj.com, 5 Oct 1999 [Full text]
A selective patient cohort?: M J Carter
bmj.com, 12 Oct 1999 [Full text]
Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): Arno Dormann
bmj.com, 13 Oct 1999 [Full text]
Percutaneous endoscopic gastrostomy (PEG) and antibiotics: Brian Scott
bmj.com, 22 Oct 1999 [Full text]