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LASER THERAPY IN GASTRIC STOMA INJURIES OF CHILDREN AND ADOLESCENTS

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ClinicalTrials.gov Identifier: NCT04863196
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrostomy Complications Other: Laser therapy Treatment Group Other: Barrier Dust Treatment Group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECT OF LASER THERAPY ON MUCOSAL LESIONS OF GASTRIC STOMA OF CHILDREN AND ADOLESCENTS: RANDOMIZED CLINICAL TRIAL
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : August 10, 2021
Estimated Study Completion Date : August 10, 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Healing time with laser therapy [ Time Frame: 7 days ]
    Healing time in days of treatment since the first session

  2. Healing time with protective barrier powder [ Time Frame: 15 days ]
    Healing time in days of treatment since the first session


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04863196


Contacts
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Contact: Juliana Ferreira, PhD 11999148148 juliana.caires@hc.fm.usp.br

Locations
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Brazil
USaoPauloGH Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Juliana Ferreira, PhD    11999148148    juliana.caires@hc.fm.usp.br   
Contact: Ana Cristina Monteiro    950603321    ana.csmonteiro@hc.fm.usp.br   
Sub-Investigator: Ana Cristina Monteiro, especialista         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Juliana Ferreira, PhD Instituto da Criança HCFMUSP
More Information
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04863196    
Other Study ID Numbers: CAAE30991020.0.0000.0068
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Gastrostomy
Child
Adolescent
Laser therapy
 Low-Level Light Therapy
Peristomal lesions
Nursing care