Clinical trial NCT05667831: The Effects of Alginate Ag Dressing in the Pressure Injury Patients
Official title: Comparison of the Effects of Two Different Wound Dressing on the Pressure Injury Patients in Long-term Care Institutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Long-Term Care
Keywords: pressure injury
patient
wound infection
nurses
Lead sponsor: Tzu Chi University
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed
timeFrame: Change from baseline bacterial colony count in wound bed at 14 days
measure: Change white blood cell count
timeFrame: Change from white blood cell count at 14 day
measure: Change high sensitivity C- reactive protein(hsCRP)
timeFrame: Change from hsCRP at 14 day
Secondary outcomes:
measure: Change Wound Bed Condition Assessment Scale
timeFrame: Change from wound bed condition assessment at 14 day
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Tzu Chi University
Study officials:
affiliation: Tzu Chi University
name: Shu-Fen LO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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