NCT02351791

Brief Summary

The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

October 2, 2023

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

28 days

First QC Date

January 27, 2015

Results QC Date

January 24, 2020

Last Update Submit

September 29, 2023

Conditions

Ileostomy

Outcome Measures

Primary Outcomes (1)

  • Trans Epidermal Water Loss After Test of Patches.

    Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive).

    Approximately 7-10 hours

Study Arms (2)

Patch 1, 3 and 5

EXPERIMENTAL

Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.

Other: Patch 1Other: Patch 2Other: Patch 3Other: Patch 4Other: Patch 5Other: Patch 6

Patch 2, 4 and 6

EXPERIMENTAL

Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.

Other: Patch 1Other: Patch 2Other: Patch 3Other: Patch 4Other: Patch 5Other: Patch 6

Interventions

Patch 1OTHER

Patch 1:standard adhesive with own feces in sleeve

Patch 1, 3 and 5Patch 2, 4 and 6
Patch 2OTHER

Patch 2:standard adhesive with own feces mixture in sleeve

Patch 1, 3 and 5Patch 2, 4 and 6
Patch 3OTHER

Patch 3: standard adhesive with simulated feces in sleeve

Patch 1, 3 and 5Patch 2, 4 and 6
Patch 4OTHER

Patch 4:standard adhesive with simulated feces mixture in sleeve

Patch 1, 3 and 5Patch 2, 4 and 6
Patch 5OTHER

Patch 5:standard adhesive with buffer in sleeve

Patch 1, 3 and 5Patch 2, 4 and 6
Patch 6OTHER

Patch 6:standard adhesive with buffer mixture in sleeve

Patch 1, 3 and 5Patch 2, 4 and 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Have had an ileostomy for more than one year
  • Have normal to slightly red skin on the area used in the evaluation
  • Has an ileostomy with a diameter up to (≤) 35 mm
  • Have a peristomal area accessible for applied patches (assessed by investigator)

You may not qualify if:

  • Currently receiving or have within the past 2 months received radio- and/or chemotherapy
  • Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
  • Are pregnant or breastfeeding
  • Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
  • Participating in other interventional clinical investigations or have previously participated in this investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Videncenter for Saarheling

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Interventions

Sugp2 protein, mouse

Results Point of Contact

Title
Sara Gosk
Organization
Scientific and Regulatory affairs
dksargo@coloplast.com
+45 49113568

Study Officials

  • Lene F Nielsen, PhD

    Coloplast A/S

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 2, 2023

Results First Posted

October 2, 2023

Record last verified: 2023-09

Locations

DK(1)