Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Study Overview
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Brief Summary
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Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube dislodgements, are frequent causes of emergency department visits. The investigators have developed two G-tube dressing designs using commercially available materials and products to decrease the risk of G-tube related complications. The investigators aim in this study is to pilot two novel G-tube dressings in patients with pre-existing G-tubes to gain parental feedback on device designs, ease of use and G-tube stability in preparation for a final design and trial. Based on the feedback, further iterations will be developed and trialed in eligible study subjects.

Detailed Description
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In order to address complications associated with gastrostomy buttons (G-buttons) or tubes (G-tubes) in children, the investigators developed two multi-component securement dressings. The purpose of this study is to try these dressings and obtain parental feedback. This will involve survey using questionnaires before and after the use of two different G-tube dressings. Eligible patients will be identified by a nurse practitioner or attending surgeon. The researcher will obtain consent from the patient or their parents/legal guardian. The investigators will ask a series of questions regarding their current experience dressing and maintaining G-tube stomas. A week supply of each new prototype dressing will be provided to the patient or parent. Caregivers will be educated on the use of each dressing and will be given a number to call should they have any questions or concerns. The dressings will be changed daily and as needed. Once the patient is enrolled and provided with dressings, the investigators will perform a follow up telephone interview at one week to evaluate their experience and ensure they did not experience any adverse events. Caregivers will be given a second questionnaire to collect feedback on the dressings after two weeks either in person or over the telephone. They will be asked to choose their preferred dressing, provide feedback on advantages and disadvantages of each type and report adverse events. For inpatients, the investigators will obtain opinions from parents, patients, nurses and doctors. Photographs will be obtained at each outpatient visit or during the inpatient period for objective comparison. Once more iterations are developed, they will undergo the same clinical trial process (involving 10-15 subjects).

Official Title
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Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Conditions
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Gastrostomy Complications

Intervention / Treatment
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* Device: Gastrostomy tube dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a pre-existing a G-tube Patients presenting to the G-tube or surgery clinic for G-tube replacement at Children's Hospital, Aurora, Colorado. Patients admitted to the hospital with a pre-existing G-tube for reasons unrelated to the G-tube will be eligible for the study if they have issues with the G-tube site. Exclusion Criteria: Refusal to participate Those with other types of gastrostomy tubes (other than Mini Balloon Button) Those whose parents or legal guardians cannot be reached by telephone Prisoners Pregnant women Decisionally challenged subjects

Ages Eligible for Study
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Minimum Age: 31 Days
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enrolled subjects<br>There is only one arm to this study. The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home. | Device: Gastrostomy tube dressing<br>* Two types of dressings to secure gastrostomy tube in children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Satisfied With Current Dressings | Overall satisfaction of the current dressings used at baseline were assessed using a qualitative questionnaire. Questionnaires queried the level of agreement in the following aspects: overall satisfaction, ease of use, adequate level of security for the G-button, adherence to skin, ability to absorb leakage, cost, availability at drug store, allergenic potential and reusability. Answer choices to measure level of satisfaction were: strongly agree, agree, neutral, disagree, strongly disagree. Surveys also included open-ended questions about participant satisfaction. Survey responses were evaluated and determined to indicate Satisfied or Not Satisfied by the Investigators.This measurement reflects participants satisfaction with whatever dressing they were currently using at baseline, not with the study interventions to which they were assigned. | Baseline | 
| Number of Participants Satisfied With Experimental Dressings | Overall satisfaction of the dressings when assessed using a qualitative questionnaire. Questionnaires queried the level of agreement in the following aspects: overall satisfaction, ease of use, adequate level of security for the G-button, ease of connecting and disconnecting the feeding tube, reduction in leakage, painless device removal, improvement in gastrostomy wound appearance, preference over the traditional dressing, and whether they would purchase the securement device if it was commercially available. Answer choices to measure level of satisfaction were: strongly agree, agree, neutral, disagree, strongly disagree. Surveys also included open-ended questions about participant satisfaction. Survey responses were evaluated and determined to indicate Satisfied or Not Satisfied by the Investigators. | 1 Week |