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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peristomal skin | Other | The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin |
|
| Pre-stripped abdominal skin | Other | The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocolloid strip | Other | An adhesive strip made of hydrocolloid adhesive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peel Force | 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. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
Received radio- and/or chemotherapy within the last two months.
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).
Have dermatological problems.
Participating in other clinical studies or have previously participated in this test.
Be a daily user of a convex base-plate.
Are pregnant or breastfeeding.
Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
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| Name | Affiliation | Role |
|---|---|---|
| Tonny Karlsmark, MD | Bispebjerg Hospital, Denmark | Principal Investigator |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1: Strata Strip |
|
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| Test Period 1: Hydrocolloid Strip |
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| Test Period 2: Strata Strip |
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| Test Period 2: Hydrocolloid Strip |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-stripped Abdominal 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peel Force | 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. | 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 | Posted | Mean | Standard Deviation | Newton | 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-stripped Abdominal 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching related to a gall stone incident | Hepatobiliary disorders | Systematic Assessment | Not related to the investigational device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Henrik Sigaard Knoth | Coloplast | + 45 4911 3469 | dkhsk@coloplast.com |
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| Strata strip | Other | An adhesive strip made of the Strata adhesive |
|
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Peristomal 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Pre-stripped Abdominal Skin -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 |
| OG002 | Pre-stripped Abdominal Skin - 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 |
| OG003 | Peristomal Skin - 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 |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Peristomal 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 | 0 | 22 | 1 | 22 |
|
| Pain related to a gall stone incident | Hepatobiliary disorders | Systematic Assessment | not related to the investigational device |
|
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