Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

Hydrumedical

Status: Completed

Conditions: Colostomy Stoma

Treatments: Device: Coloplast Alterna; Device: Hydrustoma C3

Study type: Interventional

Funder types: Industry

Identifiers

NCT05466721

HydrustomaC3

Details and patient eligibility

About

The surgical ostomy process happens when it is necessary to open an organ (such as the intestine) in order to maintain a communication channel with the external environment. The need for ostomy surgery can happen as a result of illness, genetic factors, or trauma. Despite the extensive improvements in colorectal surgery, in case there is a need for total or partial extraction and exteriorization of the large intestine (colostomy), it is often necessary to perform a stoma that connects the end of the preserved intestine to the skin, in which cases it is necessary to place a a colostomy bag for stool collection. Thus, there is a substantial number of patients who need to live with a permanent abdominal stoma that significantly affects their quality of life, implying significant changes, both physical and social. It will then be necessary for patients to adjust their daily routines in order to deal with stoma care.

The primary objective of this study is to evaluate the Hydrustoma C3 medical devices (plate C3, capsule C3, night bag C3) in terms of its efficacy and safety as colostomy devices. It is also a primary objective of this study to compare the health-related quality of life in patients with colostomy when using a control and Hydrustoma C3 devices.

Enrollment: 45 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent;
• Male and Female patients;
• Adult aged ≥ 18;
• Descending and sigmoid colostomy created more than 3 months previously to the beginning of the study;
• Having formed stool and using a flat ostomy appliance;
• Able to understand the study procedures and fill questionaries;
• Able to apply and remove the ostomy device autonomously.

Exclusion criteria

• Repeated experiences of leakage with the usual ostomy device,
• Chronically liquid stools,
• Peristomal skin disorders,
• Known allergic reactions to components of the device,
• Receiving chemotherapy, radiation therapy or steroids in the previous month

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Hydrustoma C3

Experimental group

Description:

The participant will use the Hydrustoma C3 devices for 14 days and then switch into the control device for another 14 days.

Treatment:

Device: Coloplast Alterna

Device: Hydrustoma C3

Coloplast Alterna

Other group

Description:

The participant will use the control devices for 14 days and then switch into the Hydrustoma C3 devices for another 14 days.

Treatment:

Device: Coloplast Alterna

Device: Hydrustoma C3