Ileostomy - Stoma
Conditions
Keywords
Ileostomy base plate
Brief summary
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.
Detailed description
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems. The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market. The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home. 80 healthy participants with an ileostomy will be included in the study.
Interventions
DEVICEAtlas
Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
DEVICESenSura
SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
DEVICEConform 2
Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have given written Informed Consent 2. Are at least 18 years old 3. Had their ileostomy for minimum 3 months with a size between 20-40 mm 4. Have mental capacity to understand study guidelines and questionnaires 5. Are capable to changing base plate and pouches without help. The help of a caregiver is accepted. 6. Experience leakage under the base plate at least one a week 7. Are currently using a flat 2-piece base plate with mechanical coupling 8. Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study \-
Exclusion criteria
1. Pregnant or breast-feeding 2. Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator. 3. Currently receiving or have within the past 2 months received radio- and/or chemotherapy 4. Currently using steroid product on peristomal skin (injections and oral treatment are accepted) 5. Currently using a convex system 6. Participating in other clinical studies or have previously participated in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage Under the Base Plate | At every change of base plate | Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is no leakage and 24 is complete leakage under the base plate. |
Countries
Denmark
Participant flow
Recruitment details
Subjects were recruited from a user database in Denmark.
Pre-assignment details
41 subjects were enrolled, however 6 subjects did not comply with the inclusion and exclusion criteria. Four of these were terminated before testing any products. Whereas two subjects were included in the safety population as the inclusion criteria violation was first discovered after they tested a product.
Participants by arm
| Arm | Count |
|---|---|
| All Study Parcipitants All parcipitants recieved all three intervention and they are therefore combined into one group. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| First Period (14 +/- 3 Days) | Protocol Violation | 2 | 0 | 0 |
| Second Period (14 +/- 3 Days) | Adverse Event | 2 | 1 | 0 |
| Second Period (14 +/- 3 Days) | Lack of Efficacy | 0 | 1 | 1 |
| Third Period (14 +/- 3 Days) | Adverse Event | 1 | 0 | 0 |
| Third Period (14 +/- 3 Days) | Lack of Efficacy | 1 | 0 | 0 |
| Third Period (14 +/- 3 Days) | not satisfied with product | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Parcipitants |
|---|---|
| Age Continuous | 56 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 35 | 1 / 33 | 6 / 34 |
| serious Total, serious adverse events | 2 / 35 | 0 / 33 | 0 / 34 |
Outcome results
Primary
Leakage Under the Base Plate
Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is no leakage and 24 is complete leakage under the base plate.
Time frame: At every change of base plate
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atlas | Leakage Under the Base Plate | 8.2 units on a scale | Standard Deviation 5 |
| SenSura | Leakage Under the Base Plate | 5.5 units on a scale | Standard Deviation 4.8 |
| Conform2 | Leakage Under the Base Plate | 8.0 units on a scale | Standard Deviation 4.9 |