Gastrostomy ComplicationsNCT04863196
LASER THERAPY IN GASTRIC STOMA INJURIES OF CHILDREN AND ADOLESCENTS
A study testing Laser therapy Treatment Group and Barrier Dust Treatment Group in people with Gastrostomy Complications, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Gastrostomy Complications
- What is being tested?
- Laser therapy Treatment Group and Barrier Dust Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2020to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
USaoPauloGH
São Paulo, São Paulo, 05403-000
Juliana Ferreira, PhD, 11999148148, juliana.caires@hc.fm.usp.br
Ana Cristina Monteiro, 950603321, ana.csmonteiro@hc.fm.usp.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrostomy Complications
- Being tested
- Laser therapy Treatment Group, Barrier Dust Treatment Group
- Keywords
- Gastrostomy, Child, Adolescent, Laser therapy, Low-Level Light Therapy, Peristomal lesions, Nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser therapy Treatment GroupOther
laser in gastric mucosa lesion
Barrier Dust Treatment GroupOther
barrier powder in gastric mucosa lesion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Barrier Dust Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing time with laser therapy
Healing time in days of treatment since the first session
Measured: 7 days
Healing time with protective barrier powder
Healing time in days of treatment since the first session
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start10 Aug 2020
- Primary completion10 Aug 2021 (estimated)
- Study completion10 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrostomy ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliana Ferreira, PhD, Principal investigator, Instituto da Criança HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863196
- Sponsor's protocol ID
- CAAE30991020.0.0000.0068
- Status last verified
- Feb 2021
- First submitted
- 26 Feb 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF LASER THERAPY ON MUCOSAL LESIONS OF GASTRIC STOMA OF CHILDREN AND ADOLESCENTS: RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT04863196
- Acronym / sponsor ID
- CAAE30991020.0.0000.0068
- Conditions
- Gastrostomy Complications
- Keywords
- Gastrostomy, Child, Adolescent, Laser therapy, Low-Level Light Therapy, Peristomal lesions, Nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 10 Aug 2021 (estimated)
- Study completion
- 10 Aug 2023 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser therapy Treatment Group | Experimental | Other: Laser therapy Treatment GroupTreatment 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. |
| Barrier Dust Treatment Group | Active comparator | Other: Barrier Dust Treatment GroupThe 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. |
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser therapy Treatment Grouplaser in gastric mucosa lesion | Other | Laser therapy Treatment Group |
| Barrier Dust Treatment Groupbarrier powder in gastric mucosa lesion | Other | Barrier Dust Treatment Group |
Primary outcome
Healing time with laser therapy
Time frame: 7 days
Healing time in days of treatment since the first session
Healing time with protective barrier powder
Time frame: 15 days
Healing time in days of treatment since the first session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana Ferreira, PhD principal investigator
Instituto da Criança HCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy Treatment Group and Barrier Dust Treatment Group in people with Gastrostomy Complications, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana Ferreira, PhD (11999148148, juliana.caires@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing time with laser therapy (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.