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Trial Outcomes & Findings for Human Skin Test Model in Colostomists (NCT NCT01918085)

NCT ID: NCT01918085

Last Updated: 2014-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

1 hour

Results posted on

2014-03-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure
First Pre-stripped Abdominal Skin, Then Peristomal Skin
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
First Peristomal Skin, Then Pre-stripped Abdomianl Skin
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
Test Period 1: Strata Strip
STARTED
10
12
Test Period 1: Strata Strip
COMPLETED
10
11
Test Period 1: Strata Strip
NOT COMPLETED
0
1
Test Period 1: Hydrocolloid Strip
STARTED
10
11
Test Period 1: Hydrocolloid Strip
COMPLETED
10
11
Test Period 1: Hydrocolloid Strip
NOT COMPLETED
0
0
Test Period 2: Strata Strip
STARTED
10
11
Test Period 2: Strata Strip
COMPLETED
10
11
Test Period 2: Strata Strip
NOT COMPLETED
0
0
Test Period 2: Hydrocolloid Strip
STARTED
10
11
Test Period 2: Hydrocolloid Strip
COMPLETED
10
11
Test Period 2: Hydrocolloid Strip
NOT COMPLETED
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
First Pre-stripped Abdominal Skin, Then Peristomal Skin
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
First Peristomal Skin, Then Pre-stripped Abdomianl Skin
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
Test Period 1: Strata Strip
Adverse Event
0
1

Baseline Characteristics

Human Skin Test Model in Colostomists

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pre-stripped Abdominal Skin
n=10 Participants
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
Peristomal Skin
n=12 Participants
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
n=22 Participants
Total of all reporting groups
Age, Continuous
65.6 years
STANDARD_DEVIATION 5.8 • n=5 Participants
63.5 years
STANDARD_DEVIATION 7.9 • n=7 Participants
64.4 years
STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 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

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.

Outcome measures

Outcome measures
Measure
Peristomal Skin- Strata Adhesive
n=19 Participants
The peel force used to remove a strata strip) from the Peristomal skin Strata strip : An adhesive strip made of the Strata adhesive
Pre-stripped Abdominal Skin -Strata Adhesive
n=18 Participants
The peel force used to remove a strata strip from healthy abdominal skin Strata strip : An adhesive strip made of the Strata adhesive
Pre-stripped Abdominal Skin - Hydrocolloid Adhesive
n=19 Participants
The peel force used to remove a hydrocolloid strip from the Peristomal skin hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive
Peristomal Skin - Hydrocolloid Adhesive
n=20 Participants
The peel force used to remove a hydrocolloid strip from the Peristomal skin hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive
Peel Force
2.6 Newton
Standard Deviation 1.1
2.1 Newton
Standard Deviation 0.8
4.4 Newton
Standard Deviation 1.8
3.4 Newton
Standard Deviation 1.4

Adverse Events

Pre-stripped Abdominal Skin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Peristomal Skin

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Pre-stripped Abdominal Skin
n=22 participants at risk
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
Peristomal Skin
n=22 participants at risk
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
Hepatobiliary disorders
Itching related to a gall stone incident
0.00%
0/22
4.5%
1/22 • Number of events 1
Hepatobiliary disorders
Pain related to a gall stone incident
0.00%
0/22
4.5%
1/22 • Number of events 1

Additional Information

Henrik Sigaard Knoth

Coloplast

Phone: + 45 4911 3469

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place