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Effects of Critical Patient-centered Skin Care Protocol

Primary Purpose

Incontinence-associated Dermatitis, Pressure Injury

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Critical Patient-Centered Skin Care Protocol
Sponsored by
Istanbul Bilgi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incontinence-associated Dermatitis focused on measuring incontinence-associated dermatitis, pressure injury, patient-centered care, skin care protocol, skin care bundle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Taking care in the ICU for 24 hours as a stable patient, Glasgow coma scale to be at least 10 points, Having at least one of the urinary/fecal/mixed incontinence types, Being treated in the intensive care unit for at least 7 days, Being over 18 years old Exclusion Criteria: Being after cardiopulmonary resuscitation (post CPR), Brain death has occurred, Having had multiple trauma, Being diagnosed with allergic asthma Having any skin health problem before ICU admission

Sites / Locations

  • Beykoz State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient-centered skin care group

Routine skin care group

Arm Description

A patient-centered skin care protocol developed according to the Stetler Model will be applied to the experimental group.

The routine skin care of the ICU will be applied to the control group during the study.

Outcomes

Primary Outcome Measures

Change of transepidermal water loss
This outcome includes transepidermal water loss. It will be assessed by researcher with VapoMeter.
Change of skin pH
This outcome includes skin pH changing. It will be assessed by researcher with pHmeter.
Change of skin temperature
This outcome includes skin temperature changing. It will be assessed by researcher with pHmeter.

Secondary Outcome Measures

Incidence of pressure injuries
Pressure injuries will be assessed according to the EPUAP stage system
Incidence of incontinence associated dermatitis.
Incontinence associated dermatitis will be assessed according to the GLOBIAD stage system

Full Information

First Posted
March 27, 2023
Last Updated
September 27, 2023
Sponsor
Istanbul Bilgi University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05948306
Brief Title
Effects of Critical Patient-centered Skin Care Protocol
Official Title
Effects of Critical Patient-centered Skin Care Protocol on Barrier Functions of Skin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 27, 2023 (Anticipated)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Bilgi University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

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

5. Study Description

Brief Summary
Many critical diseases can damage skin and tissue integrity due to natural immobility, hemodynamic instability, poor tissue perfusion, use of medical devices and many other internal and external factors. Skin damage frequently seen in intensive care units; It can be listed as skin tears and secondary cutaneous infections, especially pressure injuries (PI) and incontinence-associated dermatitis (IAD). In the DecubICU's study, which has the largest sample number ever, published in 2021, the prevalence of pressure ulcers and related factors in 1117 intensive care units from 90 different countries were evaluated; Pressure ulcers were detected in 6747 of 13,254 patients hospitalized in the ICU, and 57% of these wounds were reported to be associated with the intensive care unit. In addition to pressure injuries, another skin problem that has also been focused on in nursing science in the last 10 years; incontinence-associated dermatitis. IAD, which develops on the skin exposed to urine and faeces, is not only a skin damage that needs to be examined on its own, but also paves the way for the development of pressure sores and can also progress together with pressure injuries. The study which was published in 2018, examined 109 intensive care patients, while the incidence of IAD was determined as 23.6%, while in 2019 another study in which 351 patients were included for 52 weeks, annual prevalence of IAD ranged from 17% and weekly incidences ranged from 0-70%. The findings of three different studies conducted in the intensive care unit are that IAD developed in 6% of 112 patients, 26.2% of 145 patients, and 65.4% of 266 patients, respectively. However, despite the limited literature, the high prevalence rates and the strong relationship between pressure injuries and incontinence associated dermatitis point to the necessity of evaluating these two skin injuries together. Each existing skin injury reduces the quality of life by causing pain and pain to the individual, and also increases hospitalizations and infection rates, placing a financial burden on the health system and causing loss of workforce. For all these reasons, skin problems are considered as a quality indicator in hospitals and the primary responsibility for maintaining skin integrity is attributed to nurses. Guidelines published by EPUAP, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance (PPPIA) in 2019 in the prevention of pressure injuries in intensive care units play a key role in determining nurses' attempts to preserve skin and tissue integrity. In the prevention of incontinence-related dermatitis, the best practices guide published by Dimitri Beckmann in 2015 should be integrated into clinics. Furthermore, the person-centered approach in skin care has been considered as a concept that should be focused on by the authors in recent years, and in a systematic review published in 2020, clinical applications of the person-centered care approach in wound care were suggested by considering the current evidence. However, the resources in which prevention strategies are focused on individual-centered care are very limited. Therefore, in this study, it was aimed to develop a critical patient-centered skin care protocol and to examine the effects of this protocol on the barrier functions of the skin. HYPOTHESES AND DETAILED AIMS ARE BELOW. The primary aim of the study is to examine the effect of critical patient centered skin care on the barrier function of the skin. The hypotheses for the primary purpose of this study are as follows: H0: Application of critical patient-centered skin care protocol has no effect on skin barrier function (skin temperature, transepidermal water loss, skin pH, and secondary infection). H1: Application of critical patient-centered skin care protocol has an effect on the barrier function of the skin (skin temperature, transepidermal water loss, skin pH, and secondary infection). The secondary aim of the study is to examine the effects critical patient-centered skin care on the incidence and development time of incontinence-associated dermatitis and pressure injuries. In this direction, the hypotheses for the secondary purpose of this study are as follows: H0: Application of critical patient-centered skin care protocol has no effect on the incidence of incontinence associated dermatitis and the incidence of pressure injury and their development times. H1: Application of critical patient-centered skin care protocol has an effect on the incidence of incontinence associated dermatitis and the incidence of pressure injury and their development times.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence-associated Dermatitis, Pressure Injury
Keywords
incontinence-associated dermatitis, pressure injury, patient-centered care, skin care protocol, skin care bundle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was planned as a randomized controlled trial including experimental and control groups.
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient-centered skin care group
Arm Type
Experimental
Arm Description
A patient-centered skin care protocol developed according to the Stetler Model will be applied to the experimental group.
Arm Title
Routine skin care group
Arm Type
No Intervention
Arm Description
The routine skin care of the ICU will be applied to the control group during the study.
Intervention Type
Other
Intervention Name(s)
Critical Patient-Centered Skin Care Protocol
Intervention Description
A patient-centered skin care protocol prepared by the researchers in accordance with the Stetler Model will be applied to the experimental group. Sub-titles of this protocol; evaluation of risk factors, examination of the skin from head to toe, skin hygiene, examining the effects of critical illness on the skin, mobilization and re-positioning, incontinence management, maintaining nutrition, and using a support surface. For each sub-heading, application items regarding patient demands and suggestions will be added.
Primary Outcome Measure Information:
Title
Change of transepidermal water loss
Description
This outcome includes transepidermal water loss. It will be assessed by researcher with VapoMeter.
Time Frame
This parameter will be measured through study completion for every day, an average of 10 for each patient.
Title
Change of skin pH
Description
This outcome includes skin pH changing. It will be assessed by researcher with pHmeter.
Time Frame
This parameter will be measured through study completion for every day, an average of 10 for each patient.
Title
Change of skin temperature
Description
This outcome includes skin temperature changing. It will be assessed by researcher with pHmeter.
Time Frame
This parameter will be measured through study completion for every day, an average of 10 for each patient.
Secondary Outcome Measure Information:
Title
Incidence of pressure injuries
Description
Pressure injuries will be assessed according to the EPUAP stage system
Time Frame
Patients included during the study will be followed for at least 10 days or through the hospitalization
Title
Incidence of incontinence associated dermatitis.
Description
Incontinence associated dermatitis will be assessed according to the GLOBIAD stage system
Time Frame
Patients included during the study will be followed for at least 10 days or through the hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Taking care in the ICU for 24 hours as a stable patient, Glasgow coma scale to be at least 10 points, Having at least one of the urinary/fecal/mixed incontinence types, Being treated in the intensive care unit for at least 7 days, Being over 18 years old Exclusion Criteria: Being after cardiopulmonary resuscitation (post CPR), Brain death has occurred, Having had multiple trauma, Being diagnosed with allergic asthma Having any skin health problem before ICU admission
Facility Information:
Facility Name
Beykoz State Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All results of the project will be shared by researcher via publishing.
IPD Sharing Time Frame
Sharing will be possible in a year. And it is available for unlimited time. Tugba Yeni as a first author is responsible for sharing.
IPD Sharing Access Criteria
Researcher worked with ICU patients and tissue viability can access to research results.
Citations:
PubMed Identifier
31513128
Citation
Campbell J, Cook JL, Doubrovsky A, Vann A, McNamara G, Coyer F. Exploring Incontinence-Associated Dermatitis in a Single Center Intensive Care Unit: A Longitudinal Point Prevalence Survey. J Wound Ostomy Continence Nurs. 2019 Sep/Oct;46(5):401-407. doi: 10.1097/WON.0000000000000571.
Results Reference
result
PubMed Identifier
32935648
Citation
Gethin G, Probst S, Stryja J, Christiansen N, Price P. Evidence for person-centred care in chronic wound care: A systematic review and recommendations for practice. J Wound Care. 2020 Sep 1;29(Sup9b):S1-S22. doi: 10.12968/jowc.2020.29.Sup9b.S1.
Results Reference
result
PubMed Identifier
32536519
Citation
Johansen E, Lind R, Sjobo B, Petosic A. Moisture associated skin damage (MASD) in intensive care patients: A Norwegian point-prevalence study. Intensive Crit Care Nurs. 2020 Oct;60:102889. doi: 10.1016/j.iccn.2020.102889. Epub 2020 Jun 11.
Results Reference
result
PubMed Identifier
33034
Citation
Telser E. [Pharmaceutic incompatibilities--pharmaceutically undesirable conditions--in feed drugs. II. Chemical incompatibilities]. Dtsch Tierarztl Wochenschr. 1979 Feb 5;86(2):69-73. No abstract available. German.
Results Reference
result
PubMed Identifier
28110903
Citation
Valls-Matarin J, Del Cotillo-Fuente M, Ribal-Prior R, Pujol-Vila M, Sandalinas-Mulero I. Incidence of moisture-associated skin damage in an intensive care unit. Enferm Intensiva. 2017 Jan-Mar;28(1):13-20. doi: 10.1016/j.enfi.2016.11.001. Epub 2017 Jan 16. English, Spanish.
Results Reference
result
PubMed Identifier
29964368
Citation
Wang X, Zhang Y, Zhang X, Zhao X, Xian H. Incidence and risk factors of incontinence-associated dermatitis among patients in the intensive care unit. J Clin Nurs. 2018 Nov;27(21-22):4150-4157. doi: 10.1111/jocn.14594. Epub 2018 Jul 26.
Results Reference
result
PubMed Identifier
30994472
Citation
Wei L, Bao Y, Chai Q, Zheng J, Xu W. Determining Risk Factors to Develop a Predictive Model of Incontinence-associated Dermatitis Among Critically Ill Patients with Fecal Incontinence: A Prospective, Quantitative Study. Wound Manag Prev. 2019 Apr;65(4):24-33.
Results Reference
result
Citation
European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide. Emily Haesler (Ed.). EPUAP/NPIAP/PPPIA: 2019.
Results Reference
result
Citation
Beeckman D et al. Proceedings of the Global IAD Expert Panel. Incontinence- associated dermatitis: moving prevention forward. Wounds International 2015.
Results Reference
result

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Effects of Critical Patient-centered Skin Care Protocol

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