The Effects of Alginate Ag Dressing in the Pressure Injury Patients

Not Applicable

Completed

• Conditions: Long-Term Care; Pressure Injury
• Interventions: Other: Alginate silver silver ion dressing

• Registration Number: NCT05667831
• Lead Sponsor: Tzu Chi University

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.

Study Timeline

• Study Start: 2021-08-13
• Study First Submitted: 2022-06-03
• Status Verified: 2022-12
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2022-12-29
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alginate silver dressing	Alginate silver silver ion dressing	The experimental group received alginate calcium and silver ion dressing

Primary Outcome Measures

Name	Time	Method
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 high sensitivity C- reactive protein(hsCRP)	Change from hsCRP at 14 day	Draw 2cc of blood for analysis of white blood cell count
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tzu Chi University; 🇨🇳 Hualien City, Taiwan