Design of a Dressing for Gastrostomy Buttons in Pediatric Population
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | Any - 25 |
| Updated: | 2/24/2018 |
| Start Date: | September 1, 2017 |
| End Date: | June 2018 |
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.
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.
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.
(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.
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
We found this trial at
1
site
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials
