LASER THERAPY IN GASTRIC STOMA INJURIES OF CHILDREN AND ADOLESCENTS

Gastrostomy Complications Clinical Trial

Official title:

EFFECT OF LASER THERAPY ON MUCOSAL LESIONS OF GASTRIC STOMA OF CHILDREN AND ADOLESCENTS: RANDOMIZED CLINICAL TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863196
• Other study ID #: CAAE30991020.0.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2020
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2021
• Source: University of Sao Paulo General Hospital
• Contact: Juliana Ferreira, PhD
• Phone: 11999148148
• Email: juliana.caires[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrostomy Complications

Intervention

Other:
• Laser therapy Treatment Group
laser in gastric mucosa lesion
• Barrier Dust Treatment Group
barrier powder in gastric mucosa lesion

Locations

Country	Name	City	State
Brazil	USaoPauloGH	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time with laser therapy	Healing time in days of treatment since the first session	7 days
Primary	Healing time with protective barrier powder	Healing time in days of treatment since the first session	15 days