Evaluation of the Effect of 4% Topical Sucralfate in Peristomal Wound Reaction prevention in Children with Endoscopic Percutaneous Gastrostomy in comparison with control group
Determination of the effect of topical sucralfate 5% on prevention of peristomal reaction in children with endoscopic percutaneous gastrostomy compared with control group
Design
A randomized controlled clinical trial with a parallel, single-blind, so that eligible individuals were randomly assigned to each of the case and control groups in a randomized block design with volume 4.
Settings and conduct
This randomized clinical trial will be performed on patients undergoing percutaneous endoscopic gastrostomy at Imam Hossein Hospital in Isfahan. Sucralfate gel 4% will be used immediately after gastrostomy and then 4 times daily (every 6 hours) as a thin-layer overlay covering at least one gram of skin around the ostomy site for 2 months. The researcher does not know which patients receive topical sucralfate and which patients do not.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient is able to do endoscopy. There are not any untreated coagulopathy, peritonitis, ascites, bowel obstruction, gastric mucosal abnormalities, previous abdominal surgery at the time of gastrostomy. Patients are not eligible for anti-inflammatory or antibiotic treatment.Exclusion criteria:Severe or advanced pyoderma gangrenosum Abdominal wall infection Need to antibiotics or anti-inflammatory medications for any non-reactive periosteal cause Gastrostomy should be removed for any reason The drug is not be used in sufficient quantity and duration for any reason Unwillingness to continue the stydy by parents or the patient
Intervention groups
Sucralfate gel 4% will be used immediately after gastrostomy and then 4 times daily (every 6 hours) as a thin-layer overlay covering at least one gram of skin around the ostomy site for 2 months. In the control group no drug is used and rinsing with normal saline will be done.
Main outcome variables
Peristomal Wound Reaction, Peristomal infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131119015455N3
Registration date:2019-12-25, 1398/10/04
Registration timing:registered_while_recruiting
Last update:2019-12-25, 1398/10/04
Update count:0
Registration date
2019-12-25, 1398/10/04
Registrant information
Name
Bahareh Abtahi-Naeini
Name of organization / entity
Skin Diseases and leishmaniasis research Center, Isfahan University of Medical Sciences, Isfahan, Ir
Country
Iran (Islamic Republic of)
Phone
+98 31 1264 2901
Email address
bahareh.abtahi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-29, 1398/07/07
Expected recruitment end date
2021-09-29, 1400/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of 4% Topical Sucralfate in Peristomal Wound Reaction prevention in Children with Endoscopic Percutaneous Gastrostomy in comparison with control group
Public title
Effect of Topical Sucralfate in Peristomal Wound Reaction prevention in Children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient is able to do endoscopy.
There are not any untreated coagulopathy, peritonitis, ascites, bowel obstruction, gastric mucosal abnormalities, previous abdominal surgery at the time of gastrostomy.
Patients are not eligible for anti-inflammatory or antibiotic treatment.
Exclusion criteria:
Severe or advanced pyoderma gangrenosum
Abdominal wall infection
Need to antibiotics or anti-inflammatory medications for any non-reactive periosteal cause
Gastrostomy should be removed for any reason
The drug is not be used in sufficient quantity and duration for any reason
Unwillingness to continue the stydy by parents or the patient
Age
From 1 month old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible individuals were randomly assigned to each of the case and control groups in a randomized block design with volume 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher does not know which patients receive topical sucralfate and which patients do not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Deputy of Isfahan University of Medical Sciences
Street address
Research and Technology Deputy of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.MUI.MED.REC.1398.297
Health conditions studied
1
Description of health condition studied
Peristomal Wound Reaction due to Endoscopic Percutaneous Gastrostomy
ICD-10 code
Z93.1
ICD-10 code description
Gastrostomy status
Primary outcomes
1
Description
Peristomal Wound Reaction
Timepoint
Evaluation of Peristomal Wound Reaction before intervention and then one week after using the topical sucralfate and then monthly for five months.
Method of measurement
Clinical evaluation, Index of Peristomal Wound Reaction grading, Index of Total Daily Peristomal Infection Score
Secondary outcomes
1
Description
Side effects of drug use
Timepoint
After drug use daily for 2 months and then monthly for up to 3 months
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group: Sucralfate gel 4% (that it will be made in School of Pharmacy and Pharmaceutical Sciences of Isfahan University of Medical Sciences) will be used immediately after gastrostomy and then 4 times daily (every 6 hours) as a thin-layer overlay covering at least one gram of skin around the ostomy site for 2 months.
Category
Prevention
2
Description
Control group: In the control group no drug is used and rinsing with normal saline will be done.