The Effects of Alginate Ag Dressing in the Pressure Injury Patients

NCT05667831 | Completed DMC

• 1 other identifier: REC110-27
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Long-Term Care

Keywords

pressure injury; patient; wound infection; nurses

Outcome Measures

Primary Outcomes (3)

• 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 from baseline bacterial colony count in wound bed at 14 days

• Change white blood cell count

  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)

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

  Change from hsCRP at 14 day

Secondary Outcomes (1)

• Change Wound Bed Condition Assessment Scale

  Change from wound bed condition assessment at 14 day

Study Arms (2)

Alginate silver dressing

EXPERIMENTAL

The experimental group received alginate calcium and silver ion dressing

Other: Alginate silver silver ion dressing

traditional dressing

NO INTERVENTION

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

Interventions

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.

Alginate silver dressing

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tzu Chi University: lead

Study Sites (1)

Tzu Chi University

Hualien City, 970374, Taiwan

Location

Related Publications (9)

• 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.

  PMID: 31721671 BACKGROUND

• 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.

  PMID: 30835604 BACKGROUND

• 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.

  PMID: 31048187 BACKGROUND

• 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.

  PMID: 28639707 BACKGROUND

• 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.

  PMID: 30793854 BACKGROUND

• 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.

  PMID: 29846686 BACKGROUND

• 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.

  PMID: 31166863 BACKGROUND

• 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.

  PMID: 24062083 RESULT

• 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.

  PMID: 24690751 RESULT

MeSH Terms

Conditions

Pressure Ulcer; Wound Infection

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Infections

Study Officials

• Shu-Fen LO, PhD

  Tzu Chi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: December 29, 2022
• Study Start: August 13, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)