LASER THERAPY IN GASTRIC STOMA INJURIES OF CHILDREN AND ADOLESCENTS

NCT04863196 | Unknown DMC

• 1 other identifier: CAAE30991020.0.0000.0068
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy Complications

Keywords

Gastrostomy; Child; Adolescent; Laser therapy; Low-Level Light Therapy; Peristomal lesions; Nursing care

Outcome Measures

Primary Outcomes (2)

• Healing time with laser therapy

  Healing time in days of treatment since the first session

  7 days

• Healing time with protective barrier powder

  Healing time in days of treatment since the first session

  15 days

Study Arms (2)

Laser therapy Treatment Group

EXPERIMENTAL

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

Barrier Dust Treatment Group

ACTIVE COMPARATOR

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

Interventions

Laser therapy Treatment Group OTHER

laser in gastric mucosa lesion

Laser therapy Treatment Group

Barrier Dust Treatment Group OTHER

barrier powder in gastric mucosa lesion

Barrier Dust Treatment Group

Eligibility Criteria

• Age: 1 Month - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

USaoPauloGH

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Study Officials

• Juliana Ferreira, PhD

  Instituto da Criança HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana Ferreira, PhD

CONTACT

11999148148; juliana.caires@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: April 28, 2021
• Study Start: August 10, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 10, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)