Gastrostomy Complications
Conditions
Keywords
Gastrostomy, Child, Adolescent, Laser therapy, Low-Level Light Therapy, Peristomal lesions, Nursing care
Brief 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.
Detailed 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.
Interventions
OTHERLaser therapy Treatment Group
laser in gastric mucosa lesion
OTHERBarrier Dust Treatment Group
barrier powder in gastric mucosa lesion
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open clinical trial to assess the healing time of a lesion present in the gastric stoma mucosa using laser therapy or protective barrier powder.
Eligibility
Sex/Gender
ALL
Age
1 Months to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing time with laser therapy | 7 days | Healing time in days of treatment since the first session |
| Healing time with protective barrier powder | 15 days | Healing time in days of treatment since the first session |
Countries
Brazil
Contacts
Primary ContactJuliana Ferreira, PhD
Outcome results
None listed