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The Effects of Alginate Ag Dressing in the Pressure Injury Patients

Primary Purpose

Pressure Injury, Long-Term Care

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Alginate silver silver ion dressing
Sponsored by
Tzu Chi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Injury focused on measuring pressure injury, patient, wound infection, nurses

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tzu Chi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alginate silver dressing

traditional dressing

Arm Description

The experimental group received alginate calcium and silver ion dressing

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

Outcomes

Primary Outcome Measures

Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed
Take bacteria from the wound bed for wound culture
Change white blood cell count
Draw 2cc of blood for analysis of white blood cell count
Change high sensitivity C- reactive protein(hsCRP)
Draw 2cc of blood for analysis of white blood cell count

Secondary Outcome Measures

Change Wound Bed Condition Assessment Scale
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.

Full Information

First Posted
June 3, 2022
Last Updated
December 27, 2022
Sponsor
Tzu Chi University
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1. Study Identification

Unique Protocol Identification Number
NCT05667831
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tzu Chi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury, Long-Term Care
Keywords
pressure injury, patient, wound infection, nurses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
Before the subjects were assigned, neither the participants, nurses nor the researchers knew whether the subjects were in the experimental group or the control group. When the patients met the inclusion criteria, the research assistant informed the clinical nurses of the results of the case assignment(experimental group or control group).
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alginate silver dressing
Arm Type
Experimental
Arm Description
The experimental group received alginate calcium and silver ion dressing
Arm Title
traditional dressing
Arm Type
No Intervention
Arm Description
Study subjects received traditional dressing changes such as wet dressing or SSD
Intervention Type
Other
Intervention Name(s)
Alginate silver silver ion dressing
Intervention Description
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 Outcome Measure Information:
Title
Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed
Description
Take bacteria from the wound bed for wound culture
Time Frame
Change from baseline bacterial colony count in wound bed at 14 days
Title
Change white blood cell count
Description
Draw 2cc of blood for analysis of white blood cell count
Time Frame
Change from white blood cell count at 14 day
Title
Change high sensitivity C- reactive protein(hsCRP)
Description
Draw 2cc of blood for analysis of white blood cell count
Time Frame
Change from hsCRP at 14 day
Secondary Outcome Measure Information:
Title
Change Wound Bed Condition Assessment Scale
Description
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.
Time Frame
Change from wound bed condition assessment at 14 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-Fen LO, PhD
Organizational Affiliation
Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tzu Chi University
City
Hualien City
ZIP/Postal Code
970374
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
According the guidelines of the Declaration of Helsinki.The data presented in this study are available on request from the corresponding author
Citations:
PubMed Identifier
31721671
Citation
Anthony D, Alosoumi D, Safari R. Prevalence of pressure ulcers in long-term care: a global review. J Wound Care. 2019 Nov 2;28(11):702-709. doi: 10.12968/jowc.2019.28.11.702.
Results Reference
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PubMed Identifier
30835604
Citation
Atkin L, Bucko Z, Conde Montero E, Cutting K, Moffatt C, Probst A, Romanelli M, Schultz GS, Tettelbach W. Implementing TIMERS: the race against hard-to-heal wounds. J Wound Care. 2019 Mar 1;23(Sup3a):S1-S50. doi: 10.12968/jowc.2019.28.Sup3a.S1. No abstract available.
Results Reference
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PubMed Identifier
31048187
Citation
Chamorro AM, Vidal Thomas MC, Mieras AS, Leiva A, Martinez MP, Hernandez Yeste MMS; Grupo UPP. Multicenter randomized controlled trial comparing the effectiveness and safety of hydrocellular and hydrocolloid dressings for treatment of category II pressure ulcers in patients at primary and long-term care institutions. Int J Nurs Stud. 2019 Jun;94:179-185. doi: 10.1016/j.ijnurstu.2019.03.021. Epub 2019 Apr 4.
Results Reference
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PubMed Identifier
28639707
Citation
Westby MJ, Dumville JC, Soares MO, Stubbs N, Norman G. Dressings and topical agents for treating pressure ulcers. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD011947. doi: 10.1002/14651858.CD011947.pub2.
Results Reference
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PubMed Identifier
30793854
Citation
Kim JY, Lee YJ. A study on the nursing knowledge, attitude, and performance towards pressure ulcer prevention among nurses in Korea long-term care facilities. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):29-35. doi: 10.1111/iwj.13021.
Results Reference
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PubMed Identifier
29846686
Citation
Matsubara M, Banshodani M, Takahashi A, Kawai Y, Saiki T, Yamashita M, Shiraki N, Shintaku S, Moriishi M, Masaki T, Kawanishi H. Vascular access management after percutaneous transluminal angioplasty using a calcium alginate sheet: a randomized controlled trial. Nephrol Dial Transplant. 2019 Sep 1;34(9):1592-1596. doi: 10.1093/ndt/gfy143.
Results Reference
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PubMed Identifier
31166863
Citation
Stolt M, Hjerppe A, Hietanen H, Puukka P, Haavisto E. Local treatment of pressure ulcers in long-term care: a correlational cross-sectional study. J Wound Care. 2019 Jun 2;28(6):409-415. doi: 10.12968/jowc.2019.28.6.409.
Results Reference
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PubMed Identifier
24062083
Citation
Broussard KC, Powers JG. Wound dressings: selecting the most appropriate type. Am J Clin Dermatol. 2013 Dec;14(6):449-59. doi: 10.1007/s40257-013-0046-4.
Results Reference
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PubMed Identifier
24690751
Citation
Aljezawi M, Al Qadire M, Tubaishat A. Pressure ulcers in long-term care: a point prevalence study in Jordan. Br J Nurs. 2014 Mar 27-Apr 9;23(6):S4, S6, S8, S10-1. doi: 10.12968/bjon.2014.23.Sup6.S4.
Results Reference
result

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The Effects of Alginate Ag Dressing in the Pressure Injury Patients

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