Human Skin Test Model in Colostomists

• Sponsor: Coloplast A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01918085
• Collaborator: (none)
• Enrollment: 22
• Arms: 2
• Duration (Days): 30

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.

Condition or Disease	Intervention/Treatment	Phase
Colostomy Stoma	Other: Hydrocolloid strip; Other: Strata strip	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Peristomal skin The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin	Other: Hydrocolloid strip; An adhesive strip made of hydrocolloid adhesive; Other: Strata strip; An adhesive strip made of the Strata adhesive
Other: Pre-stripped abdominal skin The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin	Other: Hydrocolloid strip; An adhesive strip made of hydrocolloid adhesive; Other: Strata strip; An adhesive strip made of the Strata adhesive

Outcome Measures

Primary Outcome Measures

1. Peel Force [1 hour]

   The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Have given written informed consent.

2. Be in the age of 45 to 75 years of age both extremes included.

3. Have had a colostomy for at least 1 year.

4. Has a colostomy with a diameter up to (≤) 40 mm.

5. Have mental capacity to understand the study guidelines and questionnaires.

6. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.

7. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.

8. Have a BMI between 20-30 kg/m2.

9. Are willing to comply with investigation procedures.

Exclusion Criteria:

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).

2. Received radio- and/or chemotherapy within the last two months.

3. Currently using or have within the last 3 weeks used topical steroid products or other skin prep products.

on peristomal skin (injections and oral treatment are accepted).

1. Have dermatological problems.

2. Participating in other clinical studies or have previously participated in this test.

3. Be a daily user of a convex base-plate.

4. Are pregnant or breastfeeding.

5. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Coloplast A/S

Investigators

• Principal Investigator: Tonny Karlsmark, MD, Bispebjerg Hospital, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coloplast A/S
• ClinicalTrials.gov Identifier: NCT01918085
• Other Study ID Numbers: CP228
• First Posted: Aug 7, 2013
• Last Update Posted: Mar 12, 2014
• Last Verified: Jan 1, 2014

Study Results

Participant Flow

Recruitment Details	The subjects were recruited in April 2012.All subjects were recruited to one site. Copenhagen Wound Healing Centre, Bispebjerg bakke 23, 2400 Copenhagen NV Denmark.
Pre-assignment Detail	Subjects must have an colostomy under 40 mm in Diameter. One subject was not randomised as the subject had a stoma with a diameter above 40 mm. Thus, 22 subjects were randomized.

Arm/Group Title	First Pre-stripped Abdominal Skin, Then Peristomal Skin	First Peristomal Skin, Then Pre-stripped Abdomianl Skin
Arm/Group Description	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin Strata strip : An adhesive strip made of the Strata adhesive Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin Strata strip : An adhesive strip made of the Strata adhesive Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive
Period Title: Test Period 1: Strata Strip
STARTED	10	12
COMPLETED	10	11
NOT COMPLETED	0	1
Period Title: Test Period 1: Strata Strip
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0
Period Title: Test Period 1: Strata Strip
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0
Period Title: Test Period 1: Strata Strip
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pre-stripped Abdominal Skin	Peristomal Skin	Total
Arm/Group Description	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin Strata strip : An adhesive strip made of the Strata adhesive Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin Strata strip : An adhesive strip made of the Strata adhesive Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive	Total of all reporting groups
Overall Participants	10	12	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.6 (5.8)	63.5 (7.9)	64.4 (7.0)
Sex: Female, Male (Count of Participants)
Female	4 40%	5 41.7%	9 40.9%
Male	6 60%	7 58.3%	13 59.1%

Outcome Measures

1. Primary Outcome

Title	Peel Force
Description	The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects.
Time Frame	1 hour

Outcome Measure Data

Analysis Population Description

Some of the measurements failed. i.e one subject was a wheel chair user and the peel force could not be measured on this person. Only the measurements that did not fail were included in the analysis

Arm/Group Title	Peristomal Skin- Strata Adhesive	Pre-stripped Abdominal Skin -Strata Adhesive	Pre-stripped Abdominal Skin - Hydrocolloid Adhesive	Peristomal Skin - Hydrocolloid Adhesive
Arm/Group Description	The peel force used to remove a strata strip) from the Peristomal skin Strata strip : An adhesive strip made of the Strata adhesive	The peel force used to remove a strata strip from healthy abdominal skin Strata strip : An adhesive strip made of the Strata adhesive	The peel force used to remove a hydrocolloid strip from the Peristomal skin hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive	The peel force used to remove a hydrocolloid strip from the Peristomal skin hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive
Measure Participants	19	18	19	20
Mean (Standard Deviation) [Newton]	2.6 (1.1)	2.1 (0.8)	4.4 (1.8)	3.4 (1.4)

Adverse Events

Arm/Group Title	Pre-stripped Abdominal Skin		Peristomal Skin
Arm/Group Description	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin Strata strip : An adhesive strip made of the Strata adhesive Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive		The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin Strata strip : An adhesive strip made of the Strata adhesive Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive
All Cause Mortality
	Pre-stripped Abdominal Skin		Peristomal Skin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-stripped Abdominal Skin		Peristomal Skin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Pre-stripped Abdominal Skin		Peristomal Skin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		1/22 (4.5%)
Hepatobiliary disorders
Itching related to a gall stone incident	0/22 (0%)	0	1/22 (4.5%)	1
Pain related to a gall stone incident	0/22 (0%)	0	1/22 (4.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.