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Wound infection and bleeding is a risk factor for pressure injury. Calcium alginate silver dressing (CASD) has been shown to be beneficial in a variety of wounds. However, evidence of its benefit in pressure injury(PI) patients in long-term care institutions, especially with respect to Taiwan population, is sparse. This study was to evaluate the effect of CASD and conventional wound dressings on the PI patients in long-term care institutions.
Background: Wound infection and bleeding is a risk factor for pressure injury. Calcium alginate silver dressing (CASD) has been shown to be beneficial in a variety of wounds. However, evidence of its benefit in PI patients in long-term care institutions, especially with respect to Taiwan population, is sparse.
Objective: To evaluate the effect of CASD and conventional wound dressings on the PI patients in long-term care institutions. The study hypothesis that when using the CASD will improving wound bed status more than conventional dressing change.
Design: Prospective, randomized trial Setting: Multiple center long-term care institutions in Taiwan. Methods: In this clinical trial, 200 PI patients will randomly assigned to treatment with either calcium alginate silver dressing or conventional wound dressings for up to 14 days or to the point of full reepithelialization of the wound. The length and depth of the studied wounds were recorded once a week. The instruments will using the PI measurement tool measured on day0, day7 and day14.The collected data were analyzed by descriptive and inferential statistical methods . The Mann-Whitney test was applied to compare primary endpoint between groups. Differences in secondary endpoint were also compared.
Expected results: PI is an indicator of care quality in long-term care institutions. However, as the population ages, PI are prone to infection and bleeding problems, causing patients to have potential health problems such as sepsis and hemoglobin reduction. The results of this study will provide evidence-based care for wound dressing in long-term care institutions, thereby improving patient care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alginate silver dressing | Experimental | The experimental group received alginate calcium and silver ion dressing |
|
| traditional dressing | No Intervention | Study subjects received traditional dressing changes such as wet dressing or SSD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginate silver silver ion dressing | Other | Alginate silver silver ion dressing is a soft, comfortable wound dressing with a high mannuronic acid content. Gels on contact with wound exudate or blood, creating a moist wound environment for optimal wound healing. Silver ions protect the dressing from a range of microorganisms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed | Take bacteria from the wound bed for wound culture | Change from baseline bacterial colony count in wound bed at 14 days |
| Change white blood cell count | Draw 2cc of blood for analysis of white blood cell count | Change from white blood cell count at 14 day |
| Change high sensitivity C- reactive protein(hsCRP) | Draw 2cc of blood for analysis of white blood cell count | Change from hsCRP at 14 day |
| Measure | Description | Time Frame |
|---|---|---|
| Change Wound Bed Condition Assessment Scale | The Wound Bed Condition Assessment(WBCA) scale comprised of 8 items rated on a five-point Likert-type scale. The WBCA had a range of possible scores from 8 to 40. A higher score indicated more worse wound bed condition. | Change from wound bed condition assessment at 14 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shu-Fen LO, PhD | Tzu Chi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tzu Chi University | Hualien City | 970374 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31721671 | Background | Anthony D, Alosoumi D, Safari R. Prevalence of pressure ulcers in long-term care: a global review. J Wound Care. 2019 Nov 2;28(11):702-709. doi: 10.12968/jowc.2019.28.11.702. | |
| 30835604 | Background | Atkin L, Bucko Z, Conde Montero E, Cutting K, Moffatt C, Probst A, Romanelli M, Schultz GS, Tettelbach W. Implementing TIMERS: the race against hard-to-heal wounds. J Wound Care. 2019 Mar 1;23(Sup3a):S1-S50. doi: 10.12968/jowc.2019.28.Sup3a.S1. No abstract available. |
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According the guidelines of the Declaration of Helsinki.The data presented in this study are available on request from the corresponding author
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007239 | Infections |
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Subjects who meet the inclusion criteria of this study will be randomly assigned by the research assistant to the experimental group or the control group by generating random numbers on the computer.
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Before the subjects were assigned, neither the participants, nurses nor the researchers knew whether the subjects were in the experimental group or the control group. When the patients met the inclusion criteria, the research assistant informed the clinical nurses of the results of the case assignment(experimental group or control group).
|
| 31048187 | Background | Chamorro AM, Vidal Thomas MC, Mieras AS, Leiva A, Martinez MP, Hernandez Yeste MMS; Grupo UPP. Multicenter randomized controlled trial comparing the effectiveness and safety of hydrocellular and hydrocolloid dressings for treatment of category II pressure ulcers in patients at primary and long-term care institutions. Int J Nurs Stud. 2019 Jun;94:179-185. doi: 10.1016/j.ijnurstu.2019.03.021. Epub 2019 Apr 4. |
| 28639707 | Background | Westby MJ, Dumville JC, Soares MO, Stubbs N, Norman G. Dressings and topical agents for treating pressure ulcers. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD011947. doi: 10.1002/14651858.CD011947.pub2. |
| 30793854 | Background | Kim JY, Lee YJ. A study on the nursing knowledge, attitude, and performance towards pressure ulcer prevention among nurses in Korea long-term care facilities. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):29-35. doi: 10.1111/iwj.13021. |
| 29846686 | Background | Matsubara M, Banshodani M, Takahashi A, Kawai Y, Saiki T, Yamashita M, Shiraki N, Shintaku S, Moriishi M, Masaki T, Kawanishi H. Vascular access management after percutaneous transluminal angioplasty using a calcium alginate sheet: a randomized controlled trial. Nephrol Dial Transplant. 2019 Sep 1;34(9):1592-1596. doi: 10.1093/ndt/gfy143. |
| 31166863 | Background | Stolt M, Hjerppe A, Hietanen H, Puukka P, Haavisto E. Local treatment of pressure ulcers in long-term care: a correlational cross-sectional study. J Wound Care. 2019 Jun 2;28(6):409-415. doi: 10.12968/jowc.2019.28.6.409. |
| 24062083 | Result | Broussard KC, Powers JG. Wound dressings: selecting the most appropriate type. Am J Clin Dermatol. 2013 Dec;14(6):449-59. doi: 10.1007/s40257-013-0046-4. |
| 24690751 | Result | Aljezawi M, Al Qadire M, Tubaishat A. Pressure ulcers in long-term care: a point prevalence study in Jordan. Br J Nurs. 2014 Mar 27-Apr 9;23(6):S4, S6, S8, S10-1. doi: 10.12968/bjon.2014.23.Sup6.S4. |