• End date
    Aug 10, 2023
  • participants needed
  • sponsor
    University of Sao Paulo General Hospital
Updated on 11 May 2021


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.


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.

Condition Gastrostomy Complications
Treatment Laser therapy Treatment Group, Barrier Dust Treatment Group
Clinical Study IdentifierNCT04863196
SponsorUniversity of Sao Paulo General Hospital
Last Modified on11 May 2021


Yes No Not Sure

Inclusion Criteria

children and adolescents from 0 to 19 years old, with
lesion in the gastric mucosa regardless of size, hospitalized or undergoing
treatment at the Renal Replacement Therapy Unit, who do not present
contraindications for phototherapy and who accept to participate in the
proposed treatment from the signing of the Age-appropriate consent form and
the legal guardian's consent form

Exclusion Criteria

patients with infection at the application site, with
photosensitivity or hypersensitivity caused by laser radiation, with a
pacemaker or other electronic implant, patients with malignant lesions or
undiagnosed lesion on the area of the stoma to be irradiated, patients and
or legal guardian who does not accept to participate
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