Limpet Device for Ostomy Complications

Overseen By Andy Obst

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Nicotine use, Chemotherapy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

92 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are: Primary Hypothesis 1: Peristomal Skin Complications will decrease Primary Hypothesis 2: Dressing Leak Rates will decrease Participants will: * Receive either the Limpet device or standard of care adhesive ostomy pouch dressing * Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are scheduling or planning concurrent chemotherapy or radiation treatment, you may not be eligible to participate.

What data supports the effectiveness of the Limpet Device for treating ostomy complications?

The research on the Esteem synergy device, which is similar to the Limpet Device, showed positive results in terms of effectiveness, comfort, and quality of life for ostomized patients. This suggests that the Limpet Device may also be effective in managing ostomy complications. ^{1 2 3 4 5}

How is the Limpet Device treatment different from other treatments for ostomy complications?

The Limpet Device is unique because it is a compressible isolation system designed to manage and protect the area around an ostomy or fistula, reducing leakage and skin irritation, which are common issues with traditional pouching systems. This innovative approach aims to improve patient comfort and quality of life by providing a more secure and effective seal compared to standard care options. ^{1 3 5 6 7}

Eligibility Criteria

This trial is for adults over 18 who are having ileostomy surgery or have an enterocutaneous fistula with significant output. Their stoma should be no larger than 1.5 inches, and the skin around it must be intact. Participants need to follow the study's procedures and understand English, Spanish, Hmong, or Somali.

Inclusion Criteria

I have a fistula on my skin with a discharge of more than 500cc in 24 hours.

I am over 18 years old.

I am scheduled for ileostomy surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Baseline

Baseline appointment clinic visit and randomization into treatment groups

1 day

1 visit (in-person)

Treatment

Participants receive either the Limpet device or standard of care adhesive ostomy pouch dressing with weekly clinic visits for device replacement, wound imaging, blood tests, and quality of life surveys

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Control
• Limpet

Trial Overview The Limpet device is being tested against standard ostomy pouches to see if it reduces complications after surgery. Patients will either get the new device or a regular dressing and will visit weekly for a month for check-ups including wound imaging and blood tests.

Participant Groups

Group I: Limpet Experimental Treatment 1 Intervention

Participants in this arm will utilize the subject device as intended to be used.

Group II: Control Active Control 1 Intervention

Standard treatment with standard of care adhesive ostomy pouches.

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Findings from Research

The new fistula and wound management system was well-received by nurses, with 21 out of 22 expressing willingness to use it for future patients, indicating strong potential for clinical adoption.

Patients reported high mobility while using the new pouches (95% of the time) and the system demonstrated significantly longer wear time compared to traditional options, enhancing overall comfort and effectiveness in managing abdominal fistulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of fistulae in the abdominal region. Hocevar, BJ., Erwin-Toth, P., Landis-Erdman, J., et al.[2016]

The adapted Ostomy Skin Tool for Brazilian culture demonstrated strong convergent validity, showing a positive correlation (r = 0.44) with pain intensity in patients with peristomal skin complications, indicating it effectively measures relevant clinical outcomes.

Interrater reliability was moderate to high (κ = 0.48-0.93) when nurses assessed peristomal skin conditions in a clinical setting, suggesting that the tool can be reliably used by different healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural Adaptation and Validation of the Ostomy Skin Tool to the Brazilian Portuguese. Nunes, MLG., Martins, L., Conceição de Gouveia Santos, VL.[2023]

The Esteem synergy device, evaluated in a 16-week study with 591 ostomized patients across Spain, received 'very good' ratings in effectiveness, safety, comfort, and quality of life impact, indicating strong performance in clinical practice.

Patients consistently rated the Esteem synergy system positively, suggesting it is a suitable option for both in-hospital and out-patient use for individuals with colostomies and ileostomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new system to treat ostomy in Spain]. [2006]

In a study of 239 veterans with intestinal ostomies, factors such as age, income, employment, and preoperative care significantly influenced the severity of ostomy complications like skin irritation and leakage, with older age correlating with less severe issues.

Preoperative education and stoma site marking were associated with fewer complications and better adjustment to living with an ostomy, highlighting the importance of these practices in improving quality of life for ostomy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic and clinical factors related to ostomy complications and quality of life in veterans with an ostomy. Pittman, J., Rawl, SM., Schmidt, CM., et al.[2016]

Advancements in surgical techniques since the 1950s have significantly reduced complications associated with ostomy surgery, highlighting the importance of ongoing support for patients' physical and psychological needs.

Despite the established practices in ostomy management, there is a lack of robust research and evidence-based guidelines, which could improve patient care and access to necessary interventions and supplies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ostomy care: foundation for teaching and practice. Turnbull, GB., Erwin-Toth, P.[2007]

The article introduces innovative one-piece compressible isolation devices designed to effectively manage the area around enteric fistulas, stomas, or drain tubes, helping to seal and protect patients from effluent.

These devices are the result of collaboration between an abdominal reconstructive surgeon and a Certified Wound Ostomy Nurse, aiming to enhance patient outcomes and reduce the clinical resources needed for managing these complex surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Compressible Barrier Devices for Enteric Fistula and Ostomy Effluent Isolation. Obst, MA., Dries, D.[2020]

An international group of ostomy nurse experts developed consensus-based practice guidelines aimed at reducing pouch leakage and improving the quality of life for individuals with ostomies.

The guidelines emphasize assessing body and stoma profiles to select the best pouching system, educating patients, and establishing follow-up protocols after hospital discharge or product changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Consensus Results: Development of Practice Guidelines for Assessment of Peristomal Body and Stoma Profiles, Patient Engagement, and Patient Follow-up. Colwell, JC., Bain, KA., Hansen, AS., et al.[2020]

References

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

Management of fistulae in the abdominal region. [2016]

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

Cultural Adaptation and Validation of the Ostomy Skin Tool to the Brazilian Portuguese. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

[A new system to treat ostomy in Spain]. [2006]

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

Demographic and clinical factors related to ostomy complications and quality of life in veterans with an ostomy. [2016]

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

Ostomy care: foundation for teaching and practice. [2007]

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

New Compressible Barrier Devices for Enteric Fistula and Ostomy Effluent Isolation. [2020]

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

International Consensus Results: Development of Practice Guidelines for Assessment of Peristomal Body and Stoma Profiles, Patient Engagement, and Patient Follow-up. [2020]