Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Gastrostomy Complications Clinical Trial

Official title:

Design of a Dressing for Gastrostomy Buttons in Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142750
• Other study ID #: 17-0063
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: January 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 30, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrostomy Complications

Intervention

Device:
• Gastrostomy tube dressing
Two types of dressings to secure gastrostomy tube in children

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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