Team LowCostomy: Dedicated Toward Creating a High-quality, Low-cost Colostomy Appliance for Those in Sub-Saharan Africa and Other Low Resource Settings.
Phase: NA
Conditions: Abdominal Site, Colostomy Site
Sponsor: Duke University

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Team LowCostomy: dedicated toward creating a high-quality, low-cost 
colostomy appliance for those in Sub-Saharan Africa and other low resource 
settings. 
 
NCT05824351 
 
Contacts: 
Mentor: Ann Saterbak – ann.saterbak@duke.edu 
 
Undergraduates: 
Joanna Peng – joanna.peng@duke.edu  
Darienne Rogers – darienne.rogers@duke.edu  
Amy Guan – amy.guan@duke.edu  
Alanna Manfredini – alanna.manfredini@duke.edu 
 
PI: Amy Barto, MD – amy.barto@duke.edu 
SubI: Pooja Patel, MD – pooja.patel@duke.edu  
 
Research Abstract: 
There is an immense need for low-cost colostomy appliances among ostomy patients living in low-income 
countries in Sub-Saharan Africa. There are an estimated 1.2 million new cases globally of colorectal 
cancer annually (1). Additionally, instances of colorectal cancer and the need for colostomies is increasing 
in Sub-Saharan Africa at an annual rate of up to 6.8% in certain countries (2).  
 
Without access to colostomy products, low-income patients often resort to handmade solutions, such as 
taping a plastic bag to one’s stoma. However, these makeshift solutions are not safe, odor-proof, or leak-
proof, which lead to a decreased quality of life for these individuals. To combat this problem, we have 
developed LowCostomy: a highly affordable (<5 cent) colostomy appliance that capitalizes on utilizing 
low-cost, recycled materials in addition to a novel, all-natural formula of beeswax and pine resin that 
replaces the expensive adhesive material found in traditional adhesives for colostomy appliances. Existing 
skin-care products that separately contain beeswax and pine resin have been proven to be safe, non-
toxic, and non-corrosive (7, 8,9, 10); however, there are still potential risks for rash, irritation, infection 
and other topical reactions upon the combination of these two substances. 
 
The purpose of this study is to investigate the safety of a beeswax-pine resin mixture as it acts as a buffer 
between the patient’s peristomal skin and the colostomy appliance. Rather than testing the entire 
LowCostomy system, this study will focus solely on the safety of the beeswax-pine resin buffer. The effect 
of having the beeswax-pine resin buffer adhered to the skin on the abdomen over a one-week period will 
be analyzed independently by a licensed physician, with an emphasize on assessing changes in color, 
texture, and overall skin health using the Draize skin irritation test.  Subject surveys will also be utilized to 
record subject experiences and will include quantitative sections like the 5-D itch scale. Compiled results 
will be analyzed by an accredited statistician.  
 
Study Objective: 
To determine whether the beeswax-pine resin mixture used in the LowCostomy buffer can be safely 
applied to intact human abdominal skin for the duration of a one-week period. 
 

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Standard Research Summary 
 
Purpose of the Study: 
The objective of the study is to determine whether the beeswax-pine resin mixture used as part of the 
LowCostomy appliance as a buffer can be safely applied to human skin. “Safe” is defined as no greater 
external skin irritation or injury compared to standard commercially available ostomy appliance products 
such as the Hollister Adapt Seal barrier ring, used in a similar manner to the beeswax-pine resin buffer as 
part of the LowCostomy appliance (3).  The hypothesis to be tested is that the beeswax-pine resin 
mixture is safe for topical application to human skin. 
 
Background and Significance: 
Colorectal cancer plagues approximately 1.2 million people annually as the third most common cancer 
worldwide, causing 600,000 deaths per year (1,3). The incidence of colorectal cancer in Sub-Saharan 
Africa is estimated to be around 4.04 per 100,000 population with this value increasing (3). In fact, 
incidence of colorectal cancer in Sub-Saharan Africa is increasing annually at an average rate of 
4% (2). Common treatment for those diagnosed with any stage of colorectal cancer is to receive surgical 
intervention, commonly segmental colonic resection with an end colostomy. Unfortunately, colorectal 
cancer is only one factor contributing to the rising number of colostomy patients; trauma patients with 
intestinal obstruction via intestinal volvulus is another factor that leads to the increased number of 
colostomy patients seen in Sub-Saharan Africa (4, 11). A study performed in Ethiopia demonstrated that 
of the 33.95 surgical admissions per 100,000 population per year, 10.3% were due to intestinal 
obstructions (4). Despite the increasing number of cancer and intestinal trauma patients who receive 
colostomies, there has yet to be an affordable colostomy appliance created for the low-to-medium 
income patients for post-surgical maintenance care in low-to-medium resource countries. This is 
precisely the demand that the LowCostomy colostomy appliance aims to meet. 
 
All colostomy patients deserve high-quality, affordable colostomy appliances that enable them to 
continue their daily lives with the least amount of disruption from stool leakage, foul odor and skin 
irritation. However, high-quality colostomy appliances commercially available today are expensive and 
unavailable to those in less developed countries. For many colostomy patients in Sub-Saharan Africa, 
spending $6-10 on a high-quality colostomy appliance that only lasts two to three days inflicts an 
immense financial burden (5). In most cases, the cost of routinely purchasing high-quality colostomy 
appliances that last only a few days exceeds the average income per year for people in Sub-Saharan 
Africa. The high cost and lack of access forces many patients in Sub-Saharan Africa to resort to creating 
homemade solutions with rubber bands, tape, miscellaneous bags, and other available materials. Such 
methods often cause leakage, foul odors, discomfort, and further health complications which disrupt the 
daily life activities and overall quality of life for a colostomy patient. Surgical procedures impact one’s 
ability to monetarily provide for themselves and their families; in fact, a staggering economic productivity 
loss of $12.3 trillion due to poor provision of surgical car in low-to-middle income countries was 
projected for the period between 2015 and 2030 (6). With major health disparities among mortality rates 
and treatment options/availability, action must be taken to remedy the lack of healthcare equity in low-
resource areas (1, 4). With these shortcomings in mind, the LowCostomy appliance is designed to 
improve the quality of life for colostomy patients in low-resource settings. 
 
Despite the increase in demand for colostomy products, such supplies are still cost prohibitive; the high 
cost of colostomy appliances largely stems from the fact that companies are continually trying to 
outcompete each other’s novel adhesive formulas.  The research and development involved in this 
endeavor in turn increases the prices of colostomy products. With the effort to mitigate the cost of 

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effective adhesives, we evaluated various adhesive formulas that had the potential to be inexpensive and 
readily available for those in Sub-Saharan Africa. After various stages of testing, we formulated a mix of 
beeswax and pine resin that could replace the high-cost adhesive of most colostomy products on the 
market today. Beeswax was chosen because of its high availability and low cost in Sub-Saharan Africa; the 
pine resin is also an all-natural substance readily available that adds a more adhesive quality to the 
beeswax appliance-stoma buffer used in the LowCostomy system. Beeswax was not only chosen for its 
high availability and low cost, but beeswax is known to have antiseptic properties, making it beneficial for 
the peristomal skin which is prone to infection if skin irritation occurs. 
 
The concept of being environmentally friendly was another significant aspect that went into the design 
of the LowCostomy appliance. A typical colostomy appliance is discarded after a few days’ use. 
Additionally, many countries in Sub-Saharan Africa are already dealing with plastic pollution, resulting in 
these countries adopting a plastic bag ban. To avoid these conflicts, the LowCostomy appliance was 
designed to be made completely of recycled material, excluding the beeswax-pine buffer. Being 
composed of recycled material not only creates an environmentally friendly product, but it also provides 
a way for the appliance to be low cost. Colorectal cancer and intestinal trauma rates in Sub-Saharan 
Africa are high, and there are not adequate, low-cost solutions for post-surgical care. With this problem 
in mind, the LowCostomy appliance’s purpose is to improve the quality of life of all patients, regardless of 
socioeconomic status. However, a major component of the system has not yet been tested for safety: the 
beeswax- pine resin buffer. Thus, this study will aim to determine the safety of beeswax and pine resin as 
applied to the skin. 
 
Design and Procedures: 
The purpose of this study is to examine the safety of the LowCostomy appliance’s peristomal 
adhesive interface composed of a mix of beeswax and pine resin. Since this study is not directed at 
analyzing the efficacy of the entire LowCostomy system, only the beeswax mixture will be tested against 
test subjects’ skin. Upon consultation with ostomy nurses, the peristomal skin was determined to be 
comparable to normal abdominal skin. Thus, rather than recruiting colostomy patients, the subject pool 
will include any willing healthy adults with age +/>18 years (n=50). This subject pool must be 
heterogeneous in terms of ethnicity which ensures that a broad range of skin colors are being tested with 
the aim of removing bias toward a certain type or color of skin.  The goal is to recruit 50% of subjects who 
self-identify as having a medium to dark skin tone and 50% who self-identify as having with a light skin 
tone.  Subjects will be given $50 as compensation. 
 
Each study subject will be tested with two thin rings of the beeswax-pine resin formula—one being a 
domestic beeswax-pine sample while the other ring will be a Tanzanian beeswax-pine sample. Using both 
a domestic and international sample, we can test whether regional differences in these products might 
yield significantly different results. Such beeswax-pine samples will be tested alongside a control adhesive 
in the form of Hollister’s AdaptTM Barrier Rings. The length of the study will be 7 days. The beeswax-pine 
ring will be created to match the dimensions of the control (width: 4.5 mm, outer diameter: 48 mm). The 
beeswax-pine buffer will be composed of the same beeswax-pine resin ratio that will be used in the 
LowCostomy appliance’s overall design. Such tests will be performed on the subjects’ abdomen. Prior to 
application, a licensed physician will record observations concerning the condition of the abdominal skin 
including color, odor, texture, and hygiene. Pictures will be obtained for documentation purposes as well 
using a Nikon D5600, 24.2M pixel camera. During picture taking we will limit identification by choosing an 
area of skin with limited identifying marks or tattoos.  The camera will automatically date stamp the 
picture however, there will be no other identifiers captured. A single dedicated camera will be used for all 
photos.  At the screening visit on Day 1, a member of the research team will obtain a current medication 

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list and a medical history regarding known pre-existing skin conditions and history of skin reactions to 
elements of the study and control adhesive rings, to validate that there are no additional associated risks 
with participating in this study. If the area of application is too hairy to obtain a clear view of the skin, the 
healthcare professional will shave the pertinent area. The three areas of application will be marked with a 
medical marker to ensure even and consistent placement of the samples. A measurement device will be 
included in each picture for documentation and quantification of adverse skin reactions. The control ring 
will be applied according to the manufacturer’s instructions; the beeswax-pine rings will be placed in a 
similar fashion but in addition, will need to be massaged against the skin to build friction and heat, 
allowing for a more effective adhesion. To fully seal the rings with the skin, Tegaderm will be placed over 
the rings, which allows the study subject to shower over the 7-day period with minimal interference with 
the study results. If the initial adhesives are not able to endure the full 7 days due to adhesive or 
application failure, such results will be noted and excluded from final analysis. 
 
Each subsequent day after the initial placement of the samples, the subject will be asked to remove 
the tegaderm and the three adhesive ringsbriefly for less than 20 minutes, then promptly reapply in the 
exact same location with new tegaderm. The act of daily removal and reapplication of the samples will 
simulate 
the typical routine of colostomy patients as they remove and reapply their ostomy products.  
Twenty-four pieces of tegaderm will be provided per subject for the purpose of reapplying the 
samples. During the education session, subjects will be shown how to properly apply tegaderm over 
the three samples.  Subject participation ends at Day 7. 
 
Photo documentation with the dedicated camera will occur on Day 1 at the initial screening visit as noted 
above, as well as Day 7. Photos will be collected by trained personnel in a private room without windows. 
A licensed physician will grade the blinded photos, indicating the appropriate level of skin irritation and 
rash by utilizing the Draize skin scoring system.  Subjects will be given contact information to report any 
skin irritation or other adverse events during the 7-day trial period.  Should a severe skin reaction occur, 
subjects will be directed to the licensed physician reviewer or a consult with a dermatologist.  All subjects 
will record their experience through a RedCap survey which will include the 5D itch scale. After 
quantitative values have been assigned to each of the blinded photos, data visualizations will be created, 
and appropriate statistical analysis will be completed to evaluate for significant differences between each 
of the samples applied to subjects’ skin. 
 
Selection of Subjects/Inclusion-Exclusion Criteria: 
Subjects (N = 50) will be healthy adults with age +/>18 years and will be recruited from Duke 
University along with local community members. Subjects must verbally confirm the absence of any pre-
existing skin conditions, skin allergies to tegaderm or other adhesive products contained within the study 
and control ringsnd pregnancy.  
 
Subject Recruitment and Compensation 
Potential participants will be recruited from the community. Advertising materials in the form of flyers 
that contain a QR code directing interested participants to the study’s website will be placed around 
Duke’s campus and clinical settings as well as broader public spaces. Additionally, Duke’s ListServ email 
system will be utilized to recruit participants.  Potential participants that express interest will be 
contacted by phone to further discuss study details, answer questions, review pertinent eligibility criteria, 
and preschedule study activities.  Potential participants will not be contacted more than three times, 
including via letter, phone, email, and face-to-face interaction. If a participant states they would like to 
opt out, the study team will follow the Duke Recruitment and Engagement policy. Those who are 

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interested will be able to participate if they meet inclusion and exclusion criteria. A minimum of 50 
subjects will be recruited. Incentive payment for subjects to participate in the study will be $50. 
 
Subject’s Capacity to Give Legally Effective Consent: 
The study will not include subjects without the capacity to give legally effective consent. 
 
Risk/Benefit Assessment: 
The main risk of the study is a reaction or skin irritation caused by the beeswax-pine resin mixture. This 
could include an allergic reaction, local skin irritation, redness, itchiness, or in severe cases blistering. 
Based on background research of existing beeswax-pine resin products, it has been hypothesized that a 
reaction is unlikely, but still possible. If a reaction occurs that is too uncomfortable to continue the study 
for the entire 7 days, the subject may stop early, and the reaction will be noted. The risks of the study are 
not being borne by the likely beneficiaries. The test subjects will likely not gain any health benefits from 
participating in the study; such subjects are not colostomy patients and hence not the target consumers 
of the LowCostomy appliance. Further, if an ostomy patient happens to participate in the study, he/she 
will likely return to the use of higher-priced medical-grade colostomy appliances without the use of the 
beeswax-pine resin mixture as the LowCostomy device will be marketed to populations in low-resource 
settings. The analysis expected to result from the tests is more valuable to the target low-income patients 
of Sub-Saharan Africa, who would be using this mixture on their skin. This is the main purpose of 
providing a monetary incentive to American patients who participate. 
 
The loss of privacy and confidentiality is an additional risk.  However, every reasonable effort will be made 
to limit breaches of privacy and confidentiality. 
Costs to the Subject: 
There will be no costs to the subjects. All necessary supplies will be provided for the duration of the 
study.  
 
Data Analysis and Statistical Considerations 
Data from subjects who successfully complete the seven-day study will be used for analysis. The photos 
from Day 1 and Day 7 will be reviewed by the licensed physician using the Draize skin scoring system. 
Subjects will fill out a survey of their experiences of wearing the beeswax-pine resin adhesive. The 5-D 
itch scale will be used to quantify subjective experiences. All photos included in the dataset will be 
blinded before a licensed physician quantitatively indicate the level of skin irritation. Only the data of 
subjects who completed data collection for the entire 7-day duration will have their results quantified. 
Statistical tests will be completed on the results to draw conclusion about whether the beeswax-pine 
resin samples, in comparison to our control, caused skin irritation. 
 
Data and Safety Monitoring 
Adverse side effects of the beeswax-pine resin mixture placed on the skin may include 
redness, rash, skin irritation, and infection. In the duration of the seven-day period, subjects will be 
provided a survey at the end of each day to assess their overall well-being and to provide them a space 
to express any concerns they may have. Any significant infection or irritation of the skin that causes 
serious concern for the subject will be evaluated by a licensed physician to evaluate whether they can 
continue in the study. Any signs of infection or other adverse side effects will result in the immediate 
cessation of the seven-day period for that subject. 
 
Privacy, Data Storage & Confidentiality 

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Any data that is stored in paper or non-digital format will be locked in a file cabinet within a key-accessed 
office.  The office will be locked when not in use by the study team.  Picture data stored via camera will 
be stored in a portable lock box when transportation is needed. However, picture data will be deleted as 
soon as possible after data is transferred to a secure server. Any data that is stored in electronic format 
will be housed on a secure server behind the Duke University Medical Center firewall and/or REDCap. Any 
personnel involved with data collection will be trained on the study’s Secure Data Collection SOP. 
 
References: 
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A.O. Komolafe, O. Olaofe, A.I. Katung, A.D. Ibikunle, A.A Egberongbe, S. A. Olatoke, S.O. 
Agodirin, A.O. Adesiyun, A. Adeyeye, D. Ibrahim, J.C. Constable, K. Seier, M. Gonen, M.F. 
Brennan, T.P Kingham, Treatment of colorectal cancer in Sub-Saharan Africa: Results from a 
prospective Nigerian hospital registry. Journal of Surgical Oncology. 121, 342-349 (2019). 
2. L. Katsidzira, I. Gangaidzo, S. Thomson, S. Rusakaniko, J. Matenga, R. Ramesar, The shifting 
epidemiology of colorectal cancer in sub-Saharan Africa. The Lancet Gastroenterology and 
Hepatology. 2, 377-383 (2017). 
3. Hollister US, Ostomy Care Products, Adapt Barrier Rings 
https://www.hollister.com/en/products/ostomy-care-products/ostomyaccessories/ 
barrier-rings-and-strips/adapt-barrier-rings. Accessed November 7, 2021. 
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and unmet need of surgical disease in rural Sub-Saharan Africa. World Journal of Surgery. 36, 
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5. B. S. Buckley, J. P. Gonzalez, E. V. Razon-Gonzalez, M. P. Lopez, The people that the ostomy 
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11. SUB-SAHARAN, RESOURCE-CONSTRAINED SETTINGS IN. "INCREASING ACCESS TO SURGICAL 
SERVICES IN RESOURCE-CONSTRAINED SETTINGS IN SUB-SAHARAN AFRICA International 
meeting June 4 to June 8, 2007." (2007). 
12.