Long-Term Care, Pressure Injury
Conditions
Keywords
pressure injury, patient, wound infection, nurses
Brief summary
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
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.
Interventions
OTHERAlginate silver silver ion dressing
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.
Sponsors
Tzu Chi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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).
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 20-90 years old 2. Stage II or stage III pressure injury 3. Pressure injury wound size: length, width and depth are less than 10\*10\*2 cm 4. The patient or family agree to be willing to participate in and cooperate with the interventional treatment of this study
Exclusion criteria
1. The wound has a underming wound or a tunnel wound 2. Black crust on the wound bed 3. Participant's with unstable vital signs 4. Those who have used silver dressings or silver hydrofiber dressings in the past 30 days 5. The patient has any other related disease symptoms that may interfere with the safety and efficacy of the study results 6. Long-term care institutions are protected resettlement or homeless people without legal representatives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed | Change from baseline bacterial colony count in wound bed at 14 days | Take bacteria from the wound bed for wound culture |
| Change white blood cell count | Change from white blood cell count at 14 day | Draw 2cc of blood for analysis of white blood cell count |
| Change high sensitivity C- reactive protein(hsCRP) | Change from hsCRP at 14 day | Draw 2cc of blood for analysis of white blood cell count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Wound Bed Condition Assessment Scale | Change from wound bed condition assessment at 14 day | 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. |
Countries
Taiwan
Outcome results
None listed