Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled subjects | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastrostomy tube dressing | Device | Two types of dressings to secure gastrostomy tube in children |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven Moulton | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Saddle and Foam Gastronomy 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 |
| FG001 | Experimental: Gastronomy 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The initial 14 participants provided information for baseline measures. These participants trialed both the Foam and Saddle Gastrostomy Tube Dressings. Using the qualitative information provided from the first two experimental arms, a Third Dressing Prototype was created. A separate group of 10 participants trialed the third prototype.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Third Gastrostomy Tube Dressing Prototype |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Count of Participants | Participants | Baseline |
2 weeks
Dressing is not invasive. No risk for serious adverse event or mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foam Gastrostomy Dressing Prototype | 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 Only 10 participants completed follow up |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Child developed small pinpoint rash under the dressing. It was noted after dressing was removed. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pediatric Surgery Research Fellow | Children's Hospital Colorado | 720-777-5371 | youngmeeyoungmee@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2017 | Oct 28, 2019 | Prot_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Newly placed gastrostomy button | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Foam Gastronomy 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 |
| OG001 | Saddle Gastrostomy Tube Dressing | This group was given a 1 week supply of both the saddle and foam type gastrostomy tube dressing for trial at home. |
| OG002 | Third Prototype | Third prototype (silicone pod and flexible snap rings) |
|
|
| 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. | 4 subjects in the Saddle & Foam group and 1 in the Third Prototype did not complete the satisfaction surveys. | Posted | Count of Participants | Participants | 1 Week |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Saddle Gastrostomy Dressing Prototype | 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 Only 10 participants completed follow up | 0 | 14 | 0 | 14 | 1 | 14 |
| EG002 | Third Gastrostomy Dressing Prototype | Using feedback from the Foam and Saddle groups a third Gastrostomy Dressing Prototype was created and trialed by a new group of participants Only 9 participants completed follow up | 0 | 10 | 0 | 10 | 0 | 10 |
|
Not provided
Not provided