3D Printed Ostomy Appliance for Stoma Care

(3DPPOA Trial)

Overseen By Uma Kelavkar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Peri-stomal skin breakdown, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing ostomy appliances, so it's unlikely that your medications will be affected.

What data supports the effectiveness of the treatment 3D Printed Personalized Ostomy Appliance for stoma care?

The research on ostomy appliances highlights the importance of personalized care in improving quality of life for individuals with ostomies. The Ostomy-Q study developed a tool to measure quality-of-life outcomes, showing that factors like comfort and confidence are crucial, which suggests that personalized appliances, like 3D printed ones, could enhance these aspects. ^{1 2 3 4 5}

Is the 3D Printed Ostomy Appliance generally safe for human use?

Research indicates that 3D printing in ostomy care can improve recovery and function without increasing complications, suggesting it is generally safe for human use. ^{6 7 8 9 10}

How is the 3D Printed Personalized Ostomy Appliance treatment different from other treatments for stoma care?

The 3D Printed Personalized Ostomy Appliance is unique because it is custom-made for each patient using 3D printing technology, allowing it to fit the individual's specific anatomy. This personalized approach can improve comfort and reduce skin problems compared to standard, one-size-fits-all ostomy appliances. ^{6 8 10 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is: • Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance. Participants will * Spend 2 weeks with their standard of care ostomy appliance * Spend 2 weeks with their personalized ostomy appliance made from a 3D scan * Participate in daily surveys and weekly quality of life surveys conducted over the phone

Research Team

Farrell Adkins, MD

Principal Investigator

Carilion Clinic

Eligibility Criteria

This trial is for individuals aged 18-100 with an ostomy appliance they've used for over 6 weeks and have had at least one leakage in the week before joining. Participants must be able to consent, complete daily and weekly surveys via phone and internet, and provide an email address.

Inclusion Criteria

Must have experienced more than 1 leakage in the week leading up to day of consent

I can make my own medical decisions.

Access to phone AND computer with internet access. Patient must be able to provide electronic mailing address for e-consent documentation and REDCap surveys.

Exclusion Criteria

I have an infection around my stoma, but redness alone doesn't disqualify me.

Concern for patient being able to be reached over the phone or reliable internet access for REDCap survey completion

I have skin issues around my stoma, like ulcers or separation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Care

Participants use their standard of care ostomy appliance

2 weeks

Daily surveys and weekly quality of life surveys conducted over the phone

3D Personalized Ostomy Appliance

Participants use a personalized ostomy appliance made from a 3D scan

2 weeks

Daily surveys and weekly quality of life surveys conducted over the phone

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 3D Printed Personalized Ostomy Appliance

Trial Overview The study tests if a personalized ostomy appliance made from a 3D scan can reduce leakages compared to standard care. Participants will use their current appliance for two weeks, then switch to the personalized one for another two weeks while taking part in surveys assessing quality of life.

Participant Groups

Group I: Receiving 3D Personalized Ostomy Appliance Experimental Treatment 1 Intervention

The personalized ostomy appliances are designed based off of a 3D scan. We will scan your ostomy to create a 3D picture in the computer system that is an exact copy of your ostomy using plastic. We then apply computer aided design (CAD) tools to modify your normal ostomy baseplates.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Findings from Research

The Ostomy Algorithm demonstrated strong construct validity, with an overall correct response rate of 84.23% among 297 registered nurses using real-life clinical scenarios, indicating its effectiveness as a decision-making tool.

Participants with varying levels of ostomy knowledge performed well, with those self-reporting basic knowledge achieving the highest accuracy (87.7%), suggesting the algorithm is user-friendly and beneficial for nurses at different expertise levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Construct validation of an interactive digital algorithm for ostomy care. Beitz, JM., Gerlach, MA., Schafer, V.[2019]

The Ostomy-Q, a new 23-item questionnaire developed to assess quality-of-life outcomes for ostomy appliance users, demonstrated good internal consistency and reliability in a validation study with 200 participants, indicating it is a valid tool for measuring health-related quality of life (HRQL) in this population.

The study found that the Ostomy-Q effectively captures the impact of ostomy appliances on users' lives, particularly in the domains of Discreetness, Comfort, Confidence, and Social Life, although further exploration of social relationships and discreetness items is suggested for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ostomy-Q: Development and Psychometric Validation of an Instrument to Evaluate Outcomes Associated with Ostomy Appliances. Nafees, B., Rasmussen, M., LLoyd, A.[2017]

The Bristol Stool Form Scale (BSFS) is widely used for describing stool consistency, but it is not suitable for individuals with ostomies, who manage their digestive output through external pouches.

To address this gap, the Lincoln Ostomy Output Consistency Scale (LOOCS) has been proposed, which aims to provide standardized descriptors for ostomy outputs, enhancing communication between patients and healthcare providers and improving clinical research outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Output Consistency Scale to Standardize Ostomate Output Description in Clinical Practice and Studies. Whisenhunt, LA., Xu, LH., Yang, F., et al.[2022]

The PRISMS eHealth program was found to be feasible and acceptable for cancer patients with new ostomies, with a high recruitment rate of 86.21% and a retention rate of 73.91% over a 60-day intervention period.

Patients using PRISMS reported improvements in physical and emotional well-being, while caregivers experienced a significant reduction in caregiver burden, suggesting that this intervention could enhance health outcomes during post-surgery care transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. Xu, S., Tan, X., Ma, C., et al.[2023]

In a study involving 25 adults with ileostomies, the novel ostomy barrier ring showed a trend towards improved skin condition, with 28% of participants reporting better skin after 4 weeks, despite not reaching statistical significance.

User experience was highly positive, with a median satisfaction score of 5 out of 5, indicating that participants found the barrier ring comfortable and effective in protecting their skin, suggesting potential for longer wear times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Ostomy Barrier Ring with Assisted Flow for Individuals with an Ileostomy. Quigley, M., Hannigan, A., Dowling, C., et al.[2023]

3D printing shows promise in colorectal surgery for managing complex intestinal fistulas and creating ostomies, potentially improving recovery and function without increasing complications, based on a review of 8 articles.

The technology is still in its early stages, and further randomized control trials are needed to fully understand its effectiveness and optimize its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D-Printing Applications in Ostomy Device Creation and Complex Intestinal Fistula Management: A Scoping Review. Soh, CL., Pandiaraja, M., Powar, MP.[2023]

A new 5+1-axis 3D printing platform was developed to create support-free intestinal fistula stents, improving printing efficiency and quality compared to traditional methods.

The resulting stents demonstrated excellent mechanical properties, biocompatibility, and the ability to be customized for individual patients, making them a promising option for treating intestinal fistulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 5 + 1-Axis 3D Printing Platform for Producing Customized Intestinal Fistula Stents. Hu, Q., Cui, J., Zhang, H., et al.[2023]

The study involved 5 patients aged 59 to 81 who received patient-specific three-dimensional stoma models for education after colorectal surgery, leading to improved understanding and self-reliance in managing their stomas.

Using these 3D models for education not only helped patients learn about their stomas and associated issues but also has the potential to reduce skin problems related to stoma care, highlighting the efficacy of personalized models in patient education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness Of Three-Dimensional Printing Models for Patients with Stoma Construction. Tominaga, T., Takagi, K., Takeshita, H., et al.[2020]

The study established a digital workflow for creating custom 3D-printed mouth opening tongue-depressing (MOTD) stents for head and neck cancer patients undergoing radiotherapy, showing a significant time efficiency improvement of over 60% compared to traditional CT scanning methods.

The 3D scanning method not only reduced time but also provided higher accuracy and reproducibility in stent design, making it a superior option for creating these devices, which can help expand their use in radiation oncology practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating customized oral stents for head and neck radiotherapy using 3D scanning and printing. Zaid, M., Bajaj, N., Burrows, H., et al.[2021]

A custom 3D-printed device designed for managing enteroatmospheric fistulae was created using bioscanner imaging, allowing for personalized treatment based on each patient's unique anatomy.

The device, made from polycaprolactone (PCL), is intended to work with negative pressure wound therapy (NPWT) to help isolate the wound from intestinal effluents and promote healing, marking a novel approach in the treatment of these complex conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a bio-scanner and 3D printing to create an innovative custom made approach for the management of complex entero-atmospheric fistulas. Durán Muñoz-Cruzado, V., Calero Castro, FJ., Padillo Eguía, A., et al.[2020]

A novel 3D-printed device was successfully used for performing abdominal enterostomy and colostomy in both a human cadaver and 6 living pigs, demonstrating ease of application and a quick average surgical time of 32 minutes.

The procedure showed no postoperative complications, with healthy tissue viability observed up to 10 days post-surgery, indicating that this 3D-printed device could be a safe option for future clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficiency of Sutureless End Enterostomy by Means of a 3D-Printed Device in a Porcine Model. Sejor, E., Debs, T., Petrucciani, N., et al.[2021]

The study successfully created accurate pelvic mirror physical models using rapid prototyping techniques based on CT images, demonstrating the feasibility of this manufacturing method.

Both the cadaver pelvis model and the experimental dog pelvis model closely resembled their real counterparts, indicating high precision in the modeling process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The manufacture of pelvic mirror physical model using rapid prototyping]. Liu, Z., Zhu, T., Zheng, W., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Construct validation of an interactive digital algorithm for ostomy care. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Ostomy-Q: Development and Psychometric Validation of an Instrument to Evaluate Outcomes Associated with Ostomy Appliances. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Output Consistency Scale to Standardize Ostomate Output Description in Clinical Practice and Studies. [2022]

4. England pubmed.ncbi.nlm.nih.gov

An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Novel Ostomy Barrier Ring with Assisted Flow for Individuals with an Ileostomy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

3D-Printing Applications in Ostomy Device Creation and Complex Intestinal Fistula Management: A Scoping Review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A 5 + 1-Axis 3D Printing Platform for Producing Customized Intestinal Fistula Stents. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Usefulness Of Three-Dimensional Printing Models for Patients with Stoma Construction. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Creating customized oral stents for head and neck radiotherapy using 3D scanning and printing. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Using a bio-scanner and 3D printing to create an innovative custom made approach for the management of complex entero-atmospheric fistulas. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Efficiency of Sutureless End Enterostomy by Means of a 3D-Printed Device in a Porcine Model. [2021]

12. China pubmed.ncbi.nlm.nih.gov

[The manufacture of pelvic mirror physical model using rapid prototyping]. [2017]