Evaluate Safety and Efficacy of Innovative Medical Devices for Colostomy Patients

NCT05466721 | Completed

• 1 other identifier: HydrustomaC3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Colostomy Stoma

Outcome Measures

Primary Outcomes (4)

• Efficacy of the device (journal of capsule/bag changes)

  Efficacy will be accessed by asking patients to record on a journal/diary, for each capsule/bag change, what was the reason for the change, and the occurrence and level of leakage.

  14 days

• Quality of life of the participant (Stoma Quality of Life questionnaire)

  In order to compare stoma related quality of life in patients with colostomy when using a control device and the Hydrustoma C3 devices the Stoma Quality of Life questionnaire will be used. This questionnaire is composed of 20 questions. Example of question "I worry that the bag detaches.". All questions must be answered on a scale of 1 to 4, being 1 always and 4 never.

  14 days

• Adverse effects

  Safety evaluations will be done by monitoring adverse events.

  14 days

• Safety of the device (Discolouration, Erosion, Tissue overgrowth score)

  Safety evaluations will be done by monitoring the peristomal skin using the validated Ostomy Skin tool (DET score). The DET Score is calculated by examining the peristomal skin and evaluate the skin based on the descriptions in each of the 3 domains, discolouration (D), erosion (E) and tissue overgrowth (T); and assessing the size of the area affected in each of the 3 domains. The total score is (maximum 15) calculated by adding all of the subscores from each domain together.

  14 days

Secondary Outcomes (1)

• Satisfaction of the participant (questionnaire)

  14 days

Study Arms (2)

Hydrustoma C3

EXPERIMENTAL

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

Device: Hydrustoma C3; Device: Coloplast Alterna

Coloplast Alterna

OTHER

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

Device: Hydrustoma C3; Device: Coloplast Alterna

Interventions

Hydrustoma C3 DEVICE

The participant will use the device for 14 days.

Coloplast Alterna; Hydrustoma C3

Coloplast Alterna DEVICE

The participant will use the device for 14 days.

Coloplast Alterna; Hydrustoma C3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hydrumedical: lead

Study Sites (6)

Hospital Da Senhora Da Oliveira - Guimarães

Guimarães, Braga District, 4835, Portugal

Location

Hospital de Braga

Braga, 4710, Portugal

Location

Centro Hospitalar do Tâmega e Sousa

Penafiel, 4560, Portugal

Location

Centro Hospitalar de Entre o Douro e Vouga

Santa Maria da Feira, 4520, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4430, Portugal

Location

Centro Hospitalar de Trás-os-Montes e Alto Douro

Vila Real, 5000, Portugal

Location

Study Officials

• Palmira Peixoto

  Hospital de Braga

  PRINCIPAL INVESTIGATOR

• Paula Costa

  Hospital Da Senhora Da Oliveira - Guimarães

  PRINCIPAL INVESTIGATOR

• Liliana Miranda

  Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro

  PRINCIPAL INVESTIGATOR

• Sara Costa

  Centro Hospitalar de Entre o Douro e Vouga

  PRINCIPAL INVESTIGATOR

• Glória Gonçalves

  Centro Hospitalar de Vila Nova de Gaia/Espinho

  PRINCIPAL INVESTIGATOR

• Carla Nunes

  Centro Hospitalar do Tâmega e Sousa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 20, 2022
• Study Start: June 13, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 31, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

PT (6)