Clinical Trials Logo

Clinical Trial Summary

Compare the healing time of lesions in the mucosa of the gastric stoma of children and adolescents using laser therapy versus conventional treatment with protective barrier powder.

Clinical Trial Description

Gastrostomy is a procedure indicated for children and adolescents with chronic disease such as intestinal malabsorption, swallowing disorders, neurological diseases, and can progress with peristomal lesions. Thus, it is essential that health professionals know how to take care of ostomies. Today there are several treatments for stoma injuries, however low-level light therapy has been gaining more prominence when we talk about treatment of tissue injury because it is an atraumatic method that, through its analgesic, anti-inflammatory and tissue biomodulation effects, reduces the treatment time of ample spectrum, without causing drug interactions. Therefore, this study seeks to highlight the effect of low-level light therapy on patients. Objective: To compare the healing time of lesions present in the mucosa of the gastric stoma of children and adolescents using laser therapy versus conventional treatment with protective barrier powder. Methodology: randomized, open, comparative clinical trial to assess the healing time of a lesion present in the gastric stoma mucosa using laser therapy or protective barrier powder in a sample of 70 patients aged 0 to 19 years attended by the stoma nurse in the units The work will compare two treatments (two-tailed test), with an alpha error of 5%, and with the power of the 95% test for a means test (Wilcoxon-Mann-Whitney), with an increase of 20% in the sample size, referring to possible losses during the study. The results will be presented as median (variation) or mean ± standard deviation for continuous variables and number (%) for categorical variables. The lesions will be evaluated through an initial measurement and during the treatment days, appearance and number of applications of the laser or protective barrier powder. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04863196
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Juliana Ferreira, PhD
Phone 11999148148
Email [email protected]
Status Recruiting
Phase N/A
Start date August 10, 2020
Completion date August 10, 2023

See also
  Status Clinical Trial Phase
Completed NCT03142750 - Design of a Dressing for Gastrostomy Buttons in Pediatric Population N/A
Enrolling by invitation NCT04001946 - Clinical Trial of Gastrostomy Button Securement Device N/A
Not yet recruiting NCT04804631 - Tube Feeding in Children Having a Bone Marrow Transplant
Recruiting NCT03046303 - Radical Gastrectomy Within Enhanced Recovery Programs(ERAS): a Prospective Randomized Controlled Trial N/A
Recruiting NCT04096456 - Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique
Completed NCT04331873 - Confirming Proper Replacement of Dislodged Gastrostomy Tubes in Pediatric Patients N/A
Recruiting NCT04107974 - PRG With and Without Gastropexy N/A