Health TrialsbyHealthPanel

Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication

ConditionsColostomy - StomaColostomy Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSalts Healthcare

About this trial

This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult aged over 18 years

Colostomy for 6 months or longer

Experiences any filter-related complications, such as ballooning, pancaking, odour, or faecal leakage through the filter, at least once a week (7 days)

Independent in colostomy care

Disqualifiers

Uses colostomy irrigation

Bleeding or broken peristomal skin

Receiving or had radiotherapy or chemotherapy in the last 2 months

Pregnant or breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

  • Confidence Be 1-Piece Closed Bag

    Device

    Active Chamber Filter - Circle Shape

  • Confidence Natural 1-Piece Closed Bag

    Device

    Protective Filter - Circle Shape

  • Confidence Be go 1-Piece Closed Bag

    Device

    Active Chamber Filter - Hexagon Shape

Treatment groups

27 Participants
are divided into 3 treatment groups
Group A: Confidence Be 1-Piece Closed BagActive comparator 1 intervention
Group B: Confidence Natural 1-Piece Closed BagActive comparator 1 intervention
Group C: Confidence Be go 1-Piece Closed BagActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of ballooning

Evaluation and comparison of the incidence of ballooning in colostomy bags with active chamber filter system and a protective filter

Time frame
21-days

Secondary outcomes

1

Time of ballooning incidence

Evaluation and comparison of the timing of ballooning over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter

Time frame
21-days
2

Wear time until ballooning incidence

Evaluation and comparison of the wear time duration of colostomy bags with an active chamber filter system and a protective filter until a ballooning incident occurs

Time frame
21-days
3

Incidence of pancaking

Evaluation and comparison of the incidence of pancaking in colostomy bags with an active chamber filter system and a protective filter

Time frame
21-days
4

Time of pancaking incidence

Evaluation and comparison of the timing of pancaking incidents over a 24-hour period in colostomy bags with an active chamber filter system and a protective filter

Time frame
21-days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Salts Healthcare

Lead sponsor

Source ClinicalTrials.gov
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