An interventional study of Hydrustoma C3 and Coloplast Alterna in Colostomy Stoma, sponsored by Hydrumedical. Completed at 6 sites in Portugal. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Hydrumedical · Not applicable, Interventional, and Other
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.
Hydrumedical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
The participant will use the device for 14 days.
The participant will use the device for 14 days.
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.
Time frame: 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.
Time frame: 14 days
Adverse effects
Safety evaluations will be done by monitoring adverse events.
Time frame: 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.
Time frame: 14 days
Satisfaction of the participant (questionnaire)
The patients will be asked to evaluate the medical device in terms of application, discretion of the device, stoma related noise, feelings of security (confidence) and overall satisfaction of use (including comfort and impact on body image). The questionnaire has 8 questions of multiple choice (example "Regarding the safety during usage of the devices, I feel: (1) very insecure; (2) moderately insecure; (3) Moderadately secure; (4) Very secure") and 1 open answer question.
Time frame: 14 days
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Hydrumedical