The Effects of Alginate Ag Dressing in the Pressure Injury Patients

Pressure Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05667831
• Other study ID #: REC110-27
• Status: Completed
• Phase: N/A
• Start date: August 13, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: December 2022
• Source: Tzu Chi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Long-Term Care
• Pressure Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Tzu Chi University	Hualien City

Sponsors (1)

Lead Sponsor	Collaborator
Tzu Chi University

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Change from wound bed condition assessment at 14 day