Effects of Critical Patient-centered Skin Care Protocol

Pressure Injury Clinical Trial

Official title:

Effects of Critical Patient-centered Skin Care Protocol on Barrier Functions of Skin

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05948306
• Other study ID #: 2022/81
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: Istanbul Bilgi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: March 31, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Dermatitis
• Incontinence-associated Dermatitis
• Pressure Injury

Intervention

Other:
• Critical Patient-Centered Skin Care Protocol
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.

Locations

Country	Name	City	State
Turkey	Beykoz State Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Bilgi University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Beeckman D et al. Proceedings of the Global IAD Expert Panel. Incontinence- associated dermatitis: moving prevention forward. Wounds International 2015.

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: 1 — View 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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of transepidermal water loss	This outcome includes transepidermal water loss. It will be assessed by researcher with VapoMeter.	This parameter will be measured through study completion for every day, an average of 10 for each patient.
Primary	Change of skin pH	This outcome includes skin pH changing. It will be assessed by researcher with pHmeter.	This parameter will be measured through study completion for every day, an average of 10 for each patient.
Primary	Change of skin temperature	This outcome includes skin temperature changing. It will be assessed by researcher with pHmeter.	This parameter will be measured through study completion for every day, an average of 10 for each patient.
Secondary	Incidence of pressure injuries	Pressure injuries will be assessed according to the EPUAP stage system	Patients included during the study will be followed for at least 10 days or through the hospitalization
Secondary	Incidence of incontinence associated dermatitis.	Incontinence associated dermatitis will be assessed according to the GLOBIAD stage system	Patients included during the study will be followed for at least 10 days or through the hospitalization