Trial Outcomes & Findings for Design of a Dressing for Gastrostomy Buttons in Pediatric Population (NCT NCT03142750)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Baseline

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	14	10
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foam and Saddle Gastrostomy Tube Dressing n=14 Participants 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	Third Gastrostomy Tube Dressing Prototype n=10 Participants 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.	Total n=24 Participants Total of all reporting groups
Age, Continuous	4 years n=14 Participants	4 years n=10 Participants	4 years n=24 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	6 Participants n=10 Participants	13 Participants n=24 Participants
Sex: Female, Male Male	7 Participants n=14 Participants	4 Participants n=10 Participants	11 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 Participants n=14 Participants	10 Participants n=10 Participants	24 Participants n=24 Participants
Newly placed gastrostomy button	8 Participants n=14 Participants	2 Participants n=10 Participants	10 Participants n=24 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Foam Gastronomy Tube Dressing n=8 Participants 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	Saddle Gastrostomy Tube Dressing n=8 Participants This group was given a 1 week supply of both the saddle and foam type gastrostomy tube dressing for trial at home.	Third Prototype Third prototype (silicone pod and flexible snap rings)
Number of Participants Satisfied With Current Dressings Number of participants satisfied with dressing	3 Participants	3 Participants	—
Number of Participants Satisfied With Current Dressings Number of participants not satisfied with dressing	5 Participants	5 Participants	—

PRIMARY outcome

Timeframe: 1 Week

Population: 4 subjects in the Saddle \& Foam group and 1 in the Third Prototype did not complete the satisfaction surveys.

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.

Outcome measures

Outcome measures
Measure	Foam Gastronomy Tube Dressing n=10 Participants 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	Saddle Gastrostomy Tube Dressing n=10 Participants This group was given a 1 week supply of both the saddle and foam type gastrostomy tube dressing for trial at home.	Third Prototype n=9 Participants Third prototype (silicone pod and flexible snap rings)
Number of Participants Satisfied With Experimental Dressings Satisfied with dressing	9 Participants	8 Participants	6 Participants
Number of Participants Satisfied With Experimental Dressings Not satisfied with dressing	1 Participants	2 Participants	3 Participants

Adverse Events

Foam Gastrostomy Dressing Prototype

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saddle Gastrostomy Dressing Prototype

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Third Gastrostomy Dressing Prototype

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Foam Gastrostomy Dressing Prototype n=14 participants at risk 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	Saddle Gastrostomy Dressing Prototype n=14 participants at risk 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	Third Gastrostomy Dressing Prototype n=10 participants at risk 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
Skin and subcutaneous tissue disorders Rash	0.00% 0/14 • 2 weeks Dressing is not invasive. No risk for serious adverse event or mortality.	7.1% 1/14 • Number of events 1 • 2 weeks Dressing is not invasive. No risk for serious adverse event or mortality.	0.00% 0/10 • 2 weeks Dressing is not invasive. No risk for serious adverse event or mortality.

Additional Information

Pediatric Surgery Research Fellow

Children's Hospital Colorado

Phone: 720-777-5371

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place