Health TrialsbyHealthPanel

Study of TRE Seals on Early Post-operative Subjects

ConditionOstomy
Trial statusRecruiting
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

Sponsors and contacts

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

Hollister Incorporated

Lead sponsor

Source ClinicalTrials.gov
Apply now