Clinical trial NCT03142750: Design of a Dressing for Gastrostomy Buttons in Pediatric Population
Official title: Design of a Dressing for Gastrostomy Buttons in Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy Complications
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 31
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Number of Participants Satisfied With Current Dressings
timeFrame: Baseline
measure: Number of Participants Satisfied With Experimental Dressings
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Steven Moulton
role: PRINCIPAL_INVESTIGATOR
References: