Topical Sucralfate for Prevention of Peristomal Wound Reaction related to Percutaneous Endoscopic Gastrostomy in Children: A Randomized Controlled Trial

Abstract

There are no standard protocols for peristomal skin care in children with percutaneous endoscopic gastrostomy (PEG) tubes. This clinical study aimed to evaluate the efficacy of topical sucralfate as a prophylactic intervention in the peristomal wound reaction (PWR)/infection-associated PEG insertion in children. This study was a randomized, single-blind, controlled trial recruiting child under 18 years old who submitted for PEG insertion. Patients were randomly divided to receive topical sucralfate + peristomal wound care (intervention) or peristomal wound care alone (control). In the intervention group, the participants used topical 4 sucralfate cream four times a day for two months. Participants were assessed using the total peristomal infection score and PWR grading system at baseline week 1, and monthly up to five months after the initiation of the study. Forty-four children after PEG insertion were randomly assigned to two groups. Baseline characteristics of both groups were statistically similar (P > 0.05). Friedman test demonstrated statistically significant differences in grades of PWR during the follow-up period in the control group (P = 0.01); while there was not significantly different in the intervention group (P = 0.47). This finding suggests that the intervention had a prophylaxis effect. Also, there were statistically differences in the score of erythema (P = 0.001) and exudate (P = 0.06) at the seven-time points in the control group. Topical 4 sucralfate can be considered an affordable and available prophylactic treatment for reducing the PWR/infection associated with PEG insertion in children. The trial was registered in the Iranian registry of clinical trials (http://www.irct.ir; registration no.: IRCT20131119015455N3). This article is protected by copyright. All rights reserved.