Gastrostomy Complications
Conditions
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).
Interventions
DEVICEGastrostomy tube dressing
Two types of dressings to secure gastrostomy tube in children
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
31 Days to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Satisfied With Current Dressings | Baseline | 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. |
| Number of Participants Satisfied With Experimental Dressings | 1 Week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Foam and Saddle Gastrostomy Tube Dressing The intervention includes providing one week supply of each of two gastrostomy tube dressing prototypes to try at home.
Gastrostomy tube dressing: Two types of dressings to secure gastrostomy tube in children | 14 |
| Third Gastrostomy Tube Dressing Prototype A third prototype gastronomy tube dressing will be created using the feedback collected from the first group of subjects about the Saddle and Foam dressings. A new group of participants will receive the prototype dressing. | 10 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Foam and Saddle Gastrostomy Tube Dressing | Third Gastrostomy Tube Dressing Prototype | Total |
|---|---|---|---|
| Age, Continuous | 4 years | 4 years | 4 years |
| Newly placed gastrostomy button | 8 Participants | 2 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 10 |
| other Total, other adverse events | 0 / 14 | 1 / 14 | 0 / 10 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 10 |
Outcome results
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.
Time frame: Baseline
Population: Only participants from the Foam Gastrostomy Tube Dressing and Saddle Gastrostomy Tube dressing completed this baseline measure. No participants from the Third Prototype group completed this baseline measure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foam Gastronomy Tube Dressing | Number of Participants Satisfied With Current Dressings | Number of participants satisfied with dressing | 3 Participants |
| Foam Gastronomy Tube Dressing | Number of Participants Satisfied With Current Dressings | Number of participants not satisfied with dressing | 5 Participants |
| Saddle Gastrostomy Tube Dressing | Number of Participants Satisfied With Current Dressings | Number of participants satisfied with dressing | 3 Participants |
| Saddle Gastrostomy Tube Dressing | Number of Participants Satisfied With Current Dressings | Number of participants not satisfied with dressing | 5 Participants |
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.
Time frame: 1 Week
Population: 4 subjects in the Saddle \& Foam group and 1 in the Third Prototype did not complete the satisfaction surveys.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Foam Gastronomy Tube Dressing | Number of Participants Satisfied With Experimental Dressings | Satisfied with dressing | 9 Participants |
| Foam Gastronomy Tube Dressing | Number of Participants Satisfied With Experimental Dressings | Not satisfied with dressing | 1 Participants |
| Saddle Gastrostomy Tube Dressing | Number of Participants Satisfied With Experimental Dressings | Satisfied with dressing | 8 Participants |
| Saddle Gastrostomy Tube Dressing | Number of Participants Satisfied With Experimental Dressings | Not satisfied with dressing | 2 Participants |
| Third Prototype | Number of Participants Satisfied With Experimental Dressings | Satisfied with dressing | 6 Participants |
| Third Prototype | Number of Participants Satisfied With Experimental Dressings | Not satisfied with dressing | 3 Participants |