Pressure InjuriesCVC PROTECTNCT07437040
Effect of Central Venous Catheter Dressing Types on Device-Related Pressure Injuries
A study testing Gauze Dressing and Chlorhexidine Gluconate Transparent Dressing in people with Pressure Injuries and Medical Device Related Pressure Ulcer (MDRPU), run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injuries, Medical Device Related Pressure Ulcer (MDRPU)
- What is being tested?
- Gauze Dressing and Chlorhexidine Gluconate Transparent Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2022to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul, Istanbul, 34384
About this study
Official title: The Effect of Central Venous Catheter Dressing Types on Medical Device-Related Pressure Injuries in Intensive Care Patients: A Randomized Controlled Trial
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:
Read more
- 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.
Read the 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.
- Being tested
- Gauze Dressing, Chlorhexidine Gluconate Transparent Dressing
- Keywords
- Medical Device-Related Pressure Injury, Central Venous Catheter, Catheter Dressing, Pressure Injury, Intensive Care Unit, Braden Scale
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gauze DressingDevice
Central venous catheter dressing performed using sterile gauze and adhesive tape.
Chlorhexidine Gluconate Transparent DressingDevice
Central venous catheter dressing performed using chlorhexidine gluconate-impregnated transparent dressing.
| Study group | Role | What they receive |
|---|---|---|
| Gauze and Adhesive Tape | Experimental | Participants received central venous catheter dressing using gauze and adhesive tape according to institutional protocol. Receives: Device: Gauze Dressing |
| Chlorhexidine Gluconate Transparent Dressing | Experimental | Participants received central venous catheter dressing using chlorhexidine gluconate-impregnated transparent dressing according to institutional protocol. Receives: Device: Chlorhexidine Gluconate Transparent Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical device-related pressure injury at central venous catheter site.
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).
Measured: Day 2, Day 9, and Day 16
Secondary outcomes (2)
Moisture at central venous catheter site
Assessment of moisture status at the central venous catheter insertion site during dressing changes.
Measured: Day 2, Day 9, and Day 16
Pressure injury risk (Braden Scale)
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).
Measured: Day 1, Day 2, Day 9, and Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start10 Aug 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciler Onay, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Hilal Uysal, PhD, Principal investigator, Bartın University, Department of Internal Medicine Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437040
- Sponsor's protocol ID
- E-74555795-050.01.04-391967
- Acronym
- CVC PROTECT
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study data contain potentially identifiable clinical information, and data sharing is restricted by institutional and ethics committee policies.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Central Venous Catheter Dressing Types on Medical Device-Related Pressure Injuries in Intensive Care Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07437040
- Acronym / sponsor ID
- CVC PROTECT / E-74555795-050.01.04-391967
- Keywords
- Medical Device-Related Pressure Injury, Central Venous Catheter, Catheter Dressing, Pressure Injury, Intensive Care Unit, Braden Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Gauze and Adhesive Tape | Experimental | Device: Gauze DressingParticipants received central venous catheter dressing using gauze and adhesive tape according to institutional protocol. |
| Chlorhexidine Gluconate Transparent Dressing | Experimental | Device: Chlorhexidine Gluconate Transparent DressingParticipants received central venous catheter dressing using chlorhexidine gluconate-impregnated transparent dressing according to institutional protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gauze DressingCentral venous catheter dressing performed using sterile gauze and adhesive tape. | Device | Gauze and Adhesive Tape |
| Chlorhexidine Gluconate Transparent DressingCentral venous catheter dressing performed using chlorhexidine gluconate-impregnated transparent dressing. | Device | Chlorhexidine Gluconate Transparent Dressing |
Primary outcome
Medical device-related pressure injury at central venous catheter site.
Time frame: 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).
2 secondary outcomes
Moisture at central venous catheter site
Time frame: Day 2, Day 9, and Day 16
Pressure injury risk (Braden Scale)
Time frame: Day 1, Day 2, Day 9, and Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study data contain potentially identifiable clinical information, and data sharing is restricted by institutional and ethics committee policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Uysal, PhD principal investigator
Bartın University, Department of Internal Medicine Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gauze Dressing and Chlorhexidine Gluconate Transparent Dressing in people with Pressure Injuries and Medical Device Related Pressure Ulcer (MDRPU), run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical device-related pressure injury at central venous catheter site. (time frame: Day 2, Day 9, and Day 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.