The Effects of Alginate Ag Dressing in the Pressure Injury Patients

Tzu Chi University

Status: Completed

Conditions: Pressure Injury; Long-Term Care

Treatments: Other: Alginate silver silver ion dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05667831

REC110-27

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

160 participants in 2 patient groups

Alginate silver dressing

Experimental group

Description:

The experimental group received alginate calcium and silver ion dressing

Treatment:

Other: Alginate silver silver ion dressing

traditional dressing

No Intervention group

Description:

Study subjects received traditional dressing changes such as wet dressing or SSD