The Effects of Alginate Ag Dressing in the Pressure Injury Patients

December 27, 2022 updated by: Shu-Fen Lo, Tzu Chi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hualien City, Taiwan, 970374
        • Tzu Chi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alginate silver dressing
The experimental group received alginate calcium and silver ion dressing
Other: Alginate 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.
No Intervention: traditional dressing
Study subjects received traditional dressing changes such as wet dressing or SSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline bacterial colony count in wound bed at 14 days
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
Change from white blood cell count at 14 day
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
Change from hsCRP at 14 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from wound bed condition assessment at 14 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tzu Chi University

Investigators

  • Principal Investigator: Shu-Fen LO, PhD, Tzu Chi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2021

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Estimate)

December 29, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC110-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

According the guidelines of the Declaration of Helsinki.The data presented in this study are available on request from the corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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