Design of a Dressing for Gastrostomy Buttons in Pediatric Population
Phase: NA
Conditions: Gastrostomy Complications
Sponsor: University of Colorado, Denver

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Design of a Dressing for Gastrostomy Buttons in 
Pediatric Population 
 
NCT03142750 
 
February 20, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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COMIRB Protocol 
 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  303-724-0990 
Protocol #: 17-0063 
Project Title: Design of a Dressing for Gastrostomy Buttons in Pediatric Population 
 
Principal Investigator:  
Steven L. Moulton, MD 
Version Date: 11/29/2017 
 
 
 
 
 
  
 
I. 
Hypotheses and Specific Aims  
Gastrostomy tube (G-tube) complications, such as granulation tissue formation and tube 
dislodgements, are frequent causes of emergency department visits. We have developed 
G-tube dressing designs using commercially available materials and products to decrease 
the risk of G-tube related complications. Our aim in this study is to pilot the 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.  
 
II. Background and Significance:  
The insertion of gastrostomy tubes (G-tubes) and buttons is common, with over 250,000 
devices placed each year [1]. At Children’s Hospital Colorado (CHCO) we place/replace 
about 1,500 G-tubes per year.  Initial surgical placement of a G-tube is performed open, 
percutaneously, or with laparoscopic assistance.  Unfortunately, all of these methods are 
associated with minor but troublesome postoperative complications with up to 3.9% of 
children undergoing G-tube placement estimated to have an emergency department visit 
within 30 days of discharge due to G-tube problems [2].  Maintaining and securing these 
devices to minimize granulation tissue formation while the tract matures, controlling 
leakage, appropriately up-sizing the length of the device as the child gains weight, and 
dealing with dislodged devices can be extremely challenging for patients, caregivers, and 
healthcare providers alike [3]. 
 
The most common G-tube related complications are granulation tissue formation and 
tube dislodgement, occurring in up to 59% and 28% of patients, respectively [4]. 
Granulation tissue is usually treated in an office setting with silver nitrate, but sometimes 
requires surgical excision if refractory to medical treatment. Early tube dislodgement 
causes significant morbidity and cost, requiring replacement of the tube under radiologic 
guidance or even surgery under general anesthesia if the tract is relatively new. Drainage 
around the tube is also common, with an incidence of up to 31% of patients, and often 
leads to peristomal skin irritation and breakdown [4]. The early fistula tract is composed 
of fragile granulation tissue supported by thin collagen fibers, and ulceration of this layer 
can disrupt the tract [5]. It is important, therefore, to keep the G-tube stable within the 
tract to ensure proper formation of the fistula [5]. Furthermore, the patient population 
that requires G-tube placement is often under-nourished, which can impair wound 
healing and lead to tract complications [6]. While retrospective studies have identified 

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risk factors for G-tube complications such as congenital heart disease, chronic respiratory 
failure, metabolic diseases and insurance status [4, 7], there have been no prospective 
trials to examine methods to secure G-tubes in an effort to prevent the types of 
complications described above.  
 
 
We are collaborating with a group of graduate mechanical engineering students at the 
University of Colorado Boulder to develop a new G-tube dressing. While the overall goal 
of our novel G-tube dressing method is to decrease the risk of G-tube related 
complications, this initial study aims to collect preliminary data on the design, ease of use 
and overall impressions from parents on the designs.  
 
III. Preliminary Studies/Progress Report:   
A literature review on G-tube securement methods or dressings yielded very little 
information. Use of hydrofiber dressings has been shown to help heal peristomal ulcers in 
adult patients [5]. The author reported that its absorbent property in addition to 
providing moisture and minimal adherence to the wounds likely optimized wound 
healing. Traditionally, gauze is used to protect the skin around the G-tube and to secure 
the G-tube button to minimize movement. Gauze dressings do not, however, prevent skin 
irritation and may not be optimal to heal those that occur [5].   
 
While there is lack of scientific data to support an optimal position for the G-tube, 
guidelines typically suggest that the external portion of the device should be 1-2mm 
above the skin surface to avoid excess tube movement and prevent the device from being 
too tight against the skin [8].  
 
In our 30 years of surgical practice we have noticed, as have others [3], that properly 
sized G-tubes that are well positioned, secure and are not tugged upon, and do not 
torque or rub up and down in the tract (causing friction), tend to have fewer 
complications. We have also observed that if caregivers can be taught how to place a tic-
tac-toe type dressing to secure the G-button, and then further secure the device by 
taping down the extension tubing with two or three underlying 2x2 gauze sponges to 
provide an additional point of fixation, that these devices do not move.  The tract tends to 
mature with fewer complications (i.e. granulation tissue formation, leakage, local skin 
infection) and the quality of life for children with these devices is improved, the parents 
are happier and less care is required to manage these devices. Current typical dressing is 
a tic-tac-toe type dressing consisting of 2x2 gauze and tape. 

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IV. Research Methods 
 
A.  Outcome Measure(s):   
Two questionnaires will be given to the subjects, and/or their caregivers. One will be 
given prior to first use of the two dressings (intervention) and one after the intervention. 
In the initial questionnaire we will ask questions about their current issues with G-tubes, 
current dressing method, the perceived benefits and disadvantages of the current 
dressing and overall satisfaction level. In the follow up questionnaire we will ask their 
overall satisfaction using the two types of dressings, the perceived benefits and 
disadvantages of using them, reactions or adverse events, and whether they would like to 
use them in the future. We will also review patient charts to look for any emergency 
department or office visits pertaining to issues with the G-tubes of the study subjects. We 
will also take photographs for objective assessment of peristomal conditions. 
 
B. Description of Population to be Enrolled:   
Inclusion criteria are patients aged 31 days to 25 years old with a pre-existing a G-tube 
and patients presenting to the G-tube or surgery clinic for G-tube replacement at CHCO, 
Aurora, CO. 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.  

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C. Study Design and Research Methods   
The definition of a dressing by FDA which is, Class 1 - 510(k) exempt, is as following: A 
medical adhesive tape or adhesive bandage is a device intended for medical purposes 
that consists of a strip of fabric material or plastic, coated on one side with an adhesive, 
and may include a pad of surgical dressing without a disinfectant. The device is used to 
cover and protect wounds, to hold together the skin edges of a wound, to support an 
injured part of the body, or to secure objects to the skin [9].  
 
In keeping with this definition and based on the results of our initial pilot study conducted 
under the same study protocol, a final design was developed. It was made to 
accommodate AMT MiniONE® Balloon Button, which is the standard gastrostomy button 
used at CHCO. Detailed information on the design of the dressing is provided in the 
Appendix.  
 
This is a survey study using questionnaires before and after the use of the novel 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. We 
will ask a series of questions regarding their current experience dressing and maintaining 
G-tube stomas. We aim to enroll up to 30 subjects, and approximately five of the new G-
tube dressing will be provided to the patient or parent. Caregivers will be educated on the 
use of the dressing and will be given a number to call should they have any questions or 
concerns. Once the patient is enrolled and provided with dressings, we will perform a 
follow up telephone interview at one week to evaluate their experience and ensure they 
did not experience any adverse events. They 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 provide feedback on advantages and disadvantages of each type 
and report adverse events. For inpatients, we 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. 
 
 
D.   Description, Risks and Justification of Procedures and Data Collection Tools: 
There is a small risk of developing an allergic reaction to the dressing. We do not, 
however, expect the risk to be any higher than commercially available dressings. Some 
caregivers may find it difficult to apply the dressings, but we believe these dressings are 
easy to apply, and they will be given a number to call if they have questions. We will also 
provide them with a manual on how to use the dressings. If they continue to struggle, 
they can use their previous standard dressing.  
 
There is a potential risk of patient information being accidentally seen by someone who is 
not on the research protocol. The risk is minimal. All protected information that is 
accessed and obtained as part of this protocol will be kept on a CHCO encrypted 
computer and server.  Computer and server access at CHCO is encrypted and protected 

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with a password. The computers are kept in a badge access only area of the hospital (the 
administrative pavilion). Furthermore, protected health information will be kept separate 
from other research information. Once data analysis is complete, all data related to 
individual protected health information will be destroyed.   
    
E.   Potential Scientific Problems:   
Since this study is not comparing to a control group, it is difficult to make statistical 
inference based on reports from the users. Also, the results may be biased because they 
are subjective assessments by the users, who may be accustomed to other types of 
dressings. These dressings are, however, easy to learn and use. Also, photographs will be 
used for objective assessment of peristomal wounds if there are any. Our study is 
primarily focused on evaluating parental feedback on the G-tube dressing methods and 
overall satisfaction, and then focus on development of the most optimal G-tube dressing. 
 
F.   Data Analysis Plan:   
This is a qualitative research study. We will compare feedback from patients and parents 
who trial the new G-tube dressings, to traditional dressings. Their satisfaction will be 
scored using a scale covering various aspects of the dressings.  
 
G.  Summarize Knowledge to be Gained:   
We will learn the overall experience of using these novel dressings from patients’ and 
parents’ perspectives. We will learn difficulties they faced as well as perceived benefits. 
This information will guide further development of a single best dressing method which 
will hopefully reduce the incidence of G-tube complications. 

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 H. References: 
 
1. 
Goldberg, E., et al., Gastrostomy tubes: facts, fallacies, fistulas, and false tracts. 
Gastroenterol Nurs, 2005. 28(6): p. 485-93; quiz 493-4. 
2. 
Goldin, A.B., et al., Emergency Department Visits and Readmissions among Children after 
Gastrostomy Tube Placement. J Pediatr, 2016. 174: p. 139-145 e2. 
3. 
McGrath, A., Clinical review: Overcoming the challenge of over granulation. Wounds, 2011. 
7(1): p. 42-9. 
4. 
Naiditch, J.A., T. Lautz, and K.A. Barsness, Postoperative complications in children 
undergoing gastrostomy tube placement. J Laparoendosc Adv Surg Tech A, 2010. 20(9): 
p. 781-5. 
5. 
Owada, K., Use of a hydrofiber dressing to manage PEG sites. Adv Skin Wound Care, 
2005. 18(4): p. 183-4, 186, 188-9. 
6. 
Singer, P., Nutritional care to prevent and heal pressure ulcers. Isr Med Assoc J, 2002. 
4(9): p. 713-6. 
7. 
Arnbjornsson, E., L.T. Larsson, and T. Lindhagen, Complications of laparoscopy-aided 
gastrostomies in pediatric practice. J Pediatr Surg, 1999. 34(12): p. 1843-6. 
8. 
Best, C., The correct positioning and role of an external fixation device on a PEG. Nurs 
Times, 2004. 100(18): p. 50-1. 
9. 
FDA - U.S. Food and Drug Administration. CFR - Code of Federal Regulations Title 21. 
Available from: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.5240. 
 
 

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Appendix 
 
 
 
1. Lohmann DuploMed WM81170 (XP16.4) Adhesive with Non-Woven, Breathable Backing 
2. DrawTex Absorbent 
3. NinjaFlex 85A TPU 3D Printable Plastic (lower male side) 
4. NinjaFlex 85A TPU 3D Printable Plastic (upper female side) 
5. Smooth On Dragon Skin 10 Silicone 
 
 

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Details of Each Layer: 
1. Lohmann DuploMed WM81170 (XP16.4) Adhesive 
This material is similar to what was used in the last clinical trial, except this adhesive is 
slightly stickier (5-7 day instead of 2-4 day).  The top layer is the same material (non-
woven, breathable mesh).  This material will be laser cut on CU Boulder campus; the 
ergonomic shape will allow the device to best adhere around curved surfaces without any 
“tenting” or premature peeling.  Design was influenced by the traditional rectangular 
band-aid shape.  
 
 
  
 
2. DrawTex Absorbent 
This material has not changed since the last clinical trial.  We did not receive any negative 
feedback on this material last trial, so it will be used again.  However, the material will be 
cut so that the surface area reaches within 1-2 mm of the stoma to allow any fluid to be 
wicked away from the skin.  The prior design had a clearance of about 15mm, which may 
have allowed stoma fluid to pool up before it was absorbed, resulting in prolonged 
healing.  
 
Different patients have varying stoma leakage rates, so this key component will allow 
each patient to change the absorbent without having to dispose of the entire device 
(silicone and adhesive). Extra absorbent pieces will be provided with the kit.  

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DrawTex Absorbent material is designed and manufactured by the medical company, 
SteadMed.  This will be cut into oval shapes that will fit onto the device.  Denver Rubber 
Company will be knife and die cutting the material into the shapes; they have cut medical 
grade materials before, so cleanliness standards will be in place and will be checked by 
numerous quality assurance teams.  
 
 
 
 
3/4.  NinjaFlex 85A TPU 3D Printable Plastic (upper female and lower male sides) 
This material is similar to what was used in the last clinical trial, except this plastic is 
softer, bendable, and conforms to the patient with ease.  This material is also 3D printed 
using a “Lulzbot Mini” 3D printer.  The datasheet for this NinjaFlex filament can be seen in 
the attached package.  This material will be used to mate the removable silicone feeding 
pod to the skin adhesive.   
 
As the silicon cover is curing, the female side of the plastic piece will be pressed in to form 
a mechanical bond with the silicon cover.  The lower male side will be glued to the 
Lohmann adhesive.  This is an oval shaped snap fit ring that was derived from the Ostomy 
Bag connection.  Due to the unique shape, manufacturing method, and locking geometry, 
no patents were violated for this design.  
 

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5. Smooth On Dragon Skin 10 Silicone 
This silicone material has a hardness rating of Shore 10A, which is equivalent to that of a 
rubber band.  This material will be cast into the ergonomic oval shape seen in the image 
below. This material is soft enough to conform to the patient’s skin and soft enough to 
absorb minor external forces.  It is also durable enough to create a protective shell and 
casing around the G-Button and prevent any large movements.  The Ninjaflex 3D printer 
female side will be pressed into the silicon during the molding process, so the plastic will 
be countersunk into the silicon material.  As seen in the image below, there is adequate 
space for the G-Button underneath the cap.  If an impact contacts this outer silicon layer, 
there is approximately 4-5 mm of space in the rectangular region that will protect the G-
Button from significant movement. 
 
This Smooth-On silicone material has a skin safe certification, as tested by ISO 10993; the 
certification material can be seen in the attached document.  
 
        Upper Female Side                                      Lower Male 
        Upper Female 
Lower Male Side             

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