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| ID | Type | Description | Link |
|---|---|---|---|
| B670201524231 | Other Identifier | Ethics Committee UZ Gent |
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Incontinence is a widespread problem in all health care setting. One of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.
The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus standard care (traditional water and soap) for the prevention of IAD. The second aim is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.
In this Randomized Controlled Trial, performed in 13 long-term care settings, the participants will undergo a 30 day study period. In the experimental intervention, the participants will be washed with body wash wipes and genital wipes. In the control group, the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be monitored. Subjective and objective time measurements will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wash wipes | Experimental | Washing with water and soap (standard care) will be replaced with two wash wipes during 30 days: (1) daily total body wash (using 3M Cavilon Bathing and Cleansing wipes) and (2) Continence Care (using 3M Cavilon Continence Care Wipes). No other preventive barrier or hydration products will be allowed in the genital-anal region. |
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| Standard care | Placebo Comparator | Washing will be done using water and pH neutral soap. No other preventive barrier or hydration products will be allowed in the genital-anal region. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wash wipes (3M) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and category of Incontinence-Associated Dermatitis | within the first 30 days after start of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and category of Pressure Ulcers | within the first 30 days after start of the study | |
| Comfort and tolerance of the participant | Questions on comfort and tolerance of the washing method will be assessed by the caregiver. At baseline (day 0) these questions will assess the traditional care. In the middle (day 14) and at the end of the study (day 30) the comfort and tolerance of washing with wash wipes will be assessed in the experimental group. In the control group, comfort and tolerance of traditional care will be assessed three times. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitri Beeckman, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woonzorgcentrum Sint-Jozef | Bruges | Belgium | ||||
| Woonzorgcentrum Ceder aan de Leie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24700170 | Background | Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A systematic review and meta-analysis of incontinence-associated dermatitis, incontinence, and moisture as risk factors for pressure ulcer development. Res Nurs Health. 2014 Jun;37(3):204-18. doi: 10.1002/nur.21593. Epub 2014 Apr 3. |
| Label | URL |
|---|---|
| Website of the research group | View source |
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| water and pH neutral soap | Other |
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| On baseline, at day 14 and at day 30 (the end of the study) |
| Comfort and preferences of the caregiver | Questions on comfort and preferences of the washing method will be assessed. At baseline (day 0) these questions will assess the traditional care. In the middle (day 14) and at the end of the study (day 30) the comfort and preferences of washing with wash wipes will be assessed. | On baseline, at day 14 and at day 30 (the end of the study) |
| adverse effects of the intervention | Adverse effects such as skin irritation, rash, itching, treatment related pain, skin dryness related to the interventions under study will be monitored. | within the first 30 days after start of the study |
| Cost of the experiment (use of wash wipes) versus the standard care |
| For the duration of the study (30 days) |
| Harelbeke |
| Belgium |
| Woonzorgcentrum Heilig Hart | Kortrijk | Belgium |
| Woonzorgcentrum Sint-Jozef | Kortrijk | Belgium |
| Woonzorgcentrum De Samaritaan | Nukerke | 9681 | Belgium |
| Woonzorgcentrum de Boarebreker | Ostend | Belgium |
| Woonzorgcentrum De Kroon | Sint-Gillis-Waas | Belgium |
| Woonzorgcentrum Deken Darras | Tielt | Belgium |
| Woonzorgcentrum Onze Lieve Vrouw van Lourdes | Wakken | Belgium |
| Woonzorgcentrum Duneroze | Wenduine | Belgium |
| Woonzorgcentrum Sint-Camillus | Wevelgem | Belgium |
| ID | Term |
|---|---|
| D003963 | Diaper Rash |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003877 | Dermatitis, Contact |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D012883 | Skin Ulcer |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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