Colostomy Stoma
Conditions
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.
Interventions
OTHERHydrocolloid strip
An adhesive strip made of hydrocolloid adhesive
OTHERStrata strip
An adhesive strip made of the Strata adhesive
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
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). 4. Have dermatological problems. 5. Participating in other clinical studies or have previously participated in this test. 6. Be a daily user of a convex base-plate. 7. Are pregnant or breastfeeding. 8. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 12 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Test Period 1: Strata Strip | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Pre-stripped Abdominal Skin | Peristomal Skin | Total |
|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 5.8 | 63.5 years STANDARD_DEVIATION 7.9 | 64.4 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 1 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peristomal Skin- Strata Adhesive | Peel Force | 2.6 Newton | Standard Deviation 1.1 |
| Pre-stripped Abdominal Skin -Strata Adhesive | Peel Force | 2.1 Newton | Standard Deviation 0.8 |
| Pre-stripped Abdominal Skin - Hydrocolloid Adhesive | Peel Force | 4.4 Newton | Standard Deviation 1.8 |
| Peristomal Skin - Hydrocolloid Adhesive | Peel Force | 3.4 Newton | Standard Deviation 1.4 |