LASER THERAPY IN GASTRIC STOMA INJURIES OF CHILDREN AND ADOLESCENTS

April 23, 2021 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser therapy Treatment Group

Treatment evaluation and follow-up will be done for 15 days. The application of the laser at first will be done three times a week.

The application will be by points with continuous or selective technique, which will depend on each patient. The device is a pen type that will be by contact or without contact with the lesion, irradiation and the dose will be according to the calculation for each patient, using power in milliwatt and fluency, where the dose will vary according to area and patient, and may vary from 0.1 to 1J / cm² as calculated.

The laser tip will be disinfected before each use with 70% alcohol and later coated with plastic film. Patients, companion and operator will wear specific eye protection glasses and all biosafety rules will be followed during therapy.
Other: Laser therapy Treatment Group
laser in gastric mucosa lesion
Active Comparator: Barrier Dust Treatment Group

The evaluation and follow-up of the treatment will be done for 15 days. The principle application will be made three times a week using the protective barrier powder over the entire affected area, forming a protective barrier when adhering to the skin.

For all patients, the injured area will be previously cleaned with 0.9% saline solution.
Other: Barrier Dust Treatment Group
barrier powder in gastric mucosa lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing time with laser therapy
Time Frame: 7 days
Healing time in days of treatment since the first session
7 days
Healing time with protective barrier powder
Time Frame: 15 days
Healing time in days of treatment since the first session
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Juliana Ferreira, PhD, Instituto Da Crianca HCFMUSP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2020

Primary Completion (Anticipated)

August 10, 2021

Study Completion (Anticipated)

August 10, 2023

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

April 23, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAAE30991020.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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