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NCT Number: NCT05667831

The Effects of Alginate Ag Dressing in the Pressure Injury Patients

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.

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Key information

Conditions

Pressure Injury Infections Long-Term Care Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wound Infection

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tzu Chi University

Hualien City, 970374, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alginate silver silver ion dressing

Other

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.

Primary outcomes

  1. Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed

    Time frame: Change from baseline bacterial colony count in wound bed at 14 days

    Take bacteria from the wound bed for wound culture

  2. Change white blood cell count

    Time frame: Change from white blood cell count at 14 day

    Draw 2cc of blood for analysis of white blood cell count

  3. Change high sensitivity C- reactive protein(hsCRP)

    Time frame: Change from hsCRP at 14 day

    Draw 2cc of blood for analysis of white blood cell count

Secondary outcomes

  1. Change Wound Bed Condition Assessment Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tzu Chi University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2022
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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