Health TrialsbyHealthPanel

Study of TRE Seals on Early Post-operative Subjects

ConditionOstomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHollister Incorporated

About this trial

This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age

Has their ostomy surgery and post-operative care in the United Kingdom (UK)

Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period

Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op)

Disqualifiers

Is over 85 years of age

Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.

A score of 1, 2, or 3 for any of the three OCSI Tool PSC-related domains (i.e., peristomal irritant dermatitis, peristomal bleeding, and hyperplasia) at time of enrollment

Has a fistula in the peristomal area at time of enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • An Ostomy Seal

    Device

    An absorptive ostomy seal

  • An Ostomy Ring

    Device

    The Ostomy Ring contains Aloe

Treatment groups

107 Participants
are divided into 2 treatment groups
Group A: An Ostomy SealExperimental treatment 1 intervention
Group B: An Ostomy RingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)

The three PSC-related questions on the Ostomy Complication Severity Index (OCSI) are related to peristomal irritant dermatitis, peristomal bleeding, and hyperplasia. Each of these three items is rated on a scale of 0-3, with 0 indicating absence of the condition, and 3 indicating the condition is severe.

Time frame
From enrollment to the end of treatment at 9 weeks

Secondary outcomes

1

Total Ostomy Complication Severity Index (OCSI) score and six stomal complication (non-PSC) domains of the OCSI and associated severity

Each of the OCSI items are scored on a scale of 0-3, with 0 indicating absence of the condition and 3 indicating the condition is severe.

Time frame
From enrollment to the end of treatment at 9 weeks
2

Mediation of peristomal skin complications (PSCs) by leakage absorption measured using the leakage item on the Ostomy Complication Severity Index (OCSI)

The leakage item on the OCSI has a scale of 0 (no leakage) to 3 (leakage approximately 1-2 times per day)

Time frame
From enrollment to the end of treatment at 9 weeks
3

Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question)

Assessed only if leakage is reported in the OCSI tool (conditional). Responses: Great amount / Slight amount / None (ordinal categorical).

Time frame
From enrollment to the end of treatment at 9 weeks
4

Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question)

Participant response to whether the study seal absorbed moisture/effluent from around the stoma/peristomal skin under the seal. Responses: Yes / Somewhat / No, not at all (ordinal categorical).

Time frame
From enrollment to end of treatment at 9 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Hollister Incorporated

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: