Pressure Injuries, Medical Device Related Pressure Ulcer (MDRPU)
Conditions
Keywords
Medical Device-Related Pressure Injury, Central Venous Catheter, Catheter Dressing, Pressure Injury, Intensive Care Unit, Braden Scale
Brief summary
The purpose of this clinical trial is to evaluate the effect of different central venous catheter dressing methods on the development of medical device-related pressure injuries in participants treated in the intensive care unit. This study aims to answer the following questions: * What is the risk of pressure injury development in participants whose catheter dressings are performed using gauze and adhesive tape? * What is the risk of pressure injury development in participants whose catheter dressings are performed using a chlorhexidine gluconate-containing transparent dressing? * Is there a difference between these two dressing methods in terms of pressure injury development? The researchers will compare participants receiving gauze and adhesive tape dressings with participants receiving chlorhexidine gluconate-containing transparent dressings. Participants will: * Receive catheter dressings according to the assigned dressing method based on randomization. * Undergo regular catheter site assessments. * Be evaluated for pressure injury development through skin assessments. * Have their pressure injury risk monitored using the Braden Pressure Injury Risk Assessment Scale.
Detailed description
This study is a randomized controlled experimental study designed to evaluate the effects of different central venous catheter dressing methods on the development of medical device-related pressure injuries in participants treated in the intensive care unit. The study was conducted in the intensive care unit of a tertiary-level hospital. Participants who underwent central venous catheterization and met the study protocol criteria were included. Participants were assigned to two groups using a randomization method. The randomization process was performed to ensure balanced group distribution and to minimize potential bias. In the first group, central venous catheter dressing was performed using gauze and adhesive tape. In the second group, dressing was performed using a chlorhexidine gluconate-containing transparent dressing. Participants' catheter sites were systematically assessed at predetermined observation time points. During these assessments, skin integrity, skin surface characteristics, and clinical findings related to medical device-related pressure injury development were evaluated. Catheter site evaluations were recorded using a structured observation form. Moisture at the catheter site and skin surface characteristics were assessed during routine follow-up. Participants' pressure injury risk levels were evaluated using the Braden Pressure Injury Risk Assessment Scale. Throughout the study, central venous catheter care and dressing procedures were performed in accordance with clinical protocols. Data obtained during the study were analyzed using appropriate statistical methods.
Interventions
DEVICEGauze Dressing
Central venous catheter dressing performed using sterile gauze and adhesive tape.
DEVICEChlorhexidine Gluconate Transparent Dressing
Central venous catheter dressing performed using chlorhexidine gluconate-impregnated transparent dressing.
Sponsors
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study is a randomized, parallel-group interventional trial. Eligible participants were assigned to one of two groups using randomization. In one group, central venous catheter dressings were performed using gauze and adhesive tape, while in the other group, chlorhexidine gluconate-impregnated transparent dressings were used. Participants remained in their assigned group throughout the study without crossover. Pressure injury development and risk assessments were evaluated and compared at predefined observation time points.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients hospitalized in the intensive care unit who: * Were aged 18 years or older, * Underwent a new central venous catheter insertion, * Had no pressure injury at the catheter insertion site at baseline, * Provided informed consent (patient or legal representative).
Exclusion criteria
Patients who: * Had a pressure injury at the catheter insertion site at baseline, * Had dermatological conditions affecting skin integrity at the catheter site, * Had a central venous catheter inserted at another institution, * Were discharged or deceased before completion of follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical device-related pressure injury at central venous catheter site. | Day 2, Day 9, and Day 16 | Incidence of Stage 1 medical device-related pressure injury at the central venous catheter insertion site, assessed according to the National Pressure Injury Advisory Panel (NPIAP) Staging System (Stage 1 represents non-blanchable erythema of intact skin; higher stages indicate greater tissue damage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moisture at central venous catheter site | Day 2, Day 9, and Day 16 | Assessment of moisture status at the central venous catheter insertion site during dressing changes. |
| Pressure injury risk (Braden Scale) | Day 1, Day 2, Day 9, and Day 16 | Pressure injury risk assessed using the Braden Scale for Predicting Pressure Sore Risk (total score range: 6-23; lower scores indicate higher risk of pressure injury). |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORHilal Uysal, PhD
Bartın University, Department of Internal Medicine Nursing
Outcome results
None listed