An Exploratory Study Investigating Human Skin Reaction to Output

Ileostomy Clinical Trial

Official title:

An Exploratory Study Investigating Human Skin Reaction to Output

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351791
• Other study ID #: CP254
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: September 2023
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Six types of patches are tested:

Patch 1: Standard adhesive with own feces

Patch 2: Standard adhesive with own feces mixture

Patch 3: Standard adhesive with simulated feces

Patch 4: Standard adhesive with simulated feces mixture

Patch 5: Standard adhesive with buffer (control)

Patch 6: Standard adhesive with buffer feces mixture (control)

Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.

A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ileostomy

Intervention

Other:
• Patch 1
Patch 1:standard adhesive with own feces in sleeve
• Patch 2
Patch 2:standard adhesive with own feces mixture in sleeve
• Patch 3
Patch 3: standard adhesive with simulated feces in sleeve
• Patch 4
Patch 4:standard adhesive with simulated feces mixture in sleeve
• Patch 5
Patch 5:standard adhesive with buffer in sleeve
• Patch 6
Patch 6:standard adhesive with buffer mixture in sleeve

Locations

Country	Name	City	State
Denmark	Videncenter for Saarheling	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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