Design of a Dressing for Gastrostomy Buttons in Pediatric Population

NCT ID: NCT03142750

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-08-30

Brief 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.

Detailed 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).

Conditions

Gastrostomy Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Enrolled subjects

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.

Group Type: EXPERIMENTAL

Gastrostomy tube dressing

Intervention Type: DEVICE

Two types of dressings to secure gastrostomy tube in children

Interventions

Gastrostomy tube dressing

Two types of dressings to secure gastrostomy tube in children

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 31 Days
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Moulton

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

17-0063

Identifier Type: -

Identifier Source: org_study_id