The Effects of Alginate Ag Dressing in the Pressure Injury Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of the Effects of Two Different Wound Dressing on the Pressure Injury Patients in Long-term Care Institutions

Conditions
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Pressure Injury, Long-Term Care

Intervention / Treatment
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* Other: Alginate silver silver ion dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-90 years old Stage II or stage III pressure injury Pressure injury wound size: length, width and depth are less than 10*10*2 cm The patient or family agree to be willing to participate in and cooperate with the interventional treatment of this study Exclusion Criteria: The wound has a underming wound or a tunnel wound Black crust on the wound bed Participant's with unstable vital signs Those who have used silver dressings or silver hydrofiber dressings in the past 30 days The patient has any other related disease symptoms that may interfere with the safety and efficacy of the study results Long-term care institutions are protected resettlement or homeless people without legal representatives

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alginate silver dressing<br>The experimental group received alginate calcium and silver ion dressing | Other: Alginate silver silver ion dressing<br>* 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.<br>|
| No Intervention: traditional dressing<br>Study subjects received traditional dressing changes such as wet dressing or SSD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure injury, patient, wound infection, nurses