Pressure InjuriesNCT06718777
Effect of Two Different Solutions on Wound Healing in Pressure Injury
A study testing 0.1% polyhexanide Care and 0.9 % NaCl Care in people with Pressure Injuries and Wound Care, run by Mensure Turan at 2 sites in Turkey (Türkiye).
Trial summary
Pressure injuries are a condition that reduces patients' quality of life, increases hospitalization time and healthcare costs. When accompanied by infection and complications, mortality increases. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pressure Injuries, Wound Care, Wound Cleansing
- What is being tested?
- 0.1% polyhexanide Care and 0.9 % NaCl Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Aug 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 who have developed pressure injuries
- Patients who have received informed consent from themselves or their guardians
Who cannot join
- Patients with clotting problems
- Patients using corticosteroids
- Patients receiving additional medical treatment for wound care
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gazi Yaşargil Training and Research Hospital
Diyarbakır, 21000
Gazi Yaşargil Training and Research Hospital
Diyarbakır
About this study
Official title: Effect of Two Different Solutions Used in Pressure Injury Care on Wound Healing Process
Pressure injuries are a condition that reduces patients' quality of life, increases hospitalization time and healthcare costs. When accompanied by infection and complications, mortality increases. The primary goal in pressure injuries is to prevent their occurrence, but once the injury has occurred, it is to provide effective and appropriate care. It is known that 0.9% sodium chloride (NaCl) is used routinely in pressure ulcer care. In addition, if the effectiveness of 0.1% polyhexanide in pressure ulcer care is demonstrated, it may provide data for its use in wound care. For this purpose, the study was completed as a randomized controlled trial with 32 individuals in the 0.1% polyhexanide group and 31 individuals in the 0.9% NaCl group, totaling 63 individuals.
Read the detailed description
The European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) defined pressure injury (PI) as "Local skin and/or subcutaneous tissue damage caused by pressure alone, or by a combination of pressure and shear, most often occurring over bony prominences". It has been stated that the prevalence of pressure ulcers varies between 0-72.5%, and that it is a condition that reduces the quality of life of patients, increases the length of hospital stay and health care costs. In particular, the accompanying infection and complications of PI cause increased mortality. The primary purpose of PIs is to prevent their occurrence and after the injury occurs, it is necessary to provide care with effective and appropriate methods. The determined method should have the feature that can contribute to wound healing. There are many products and methods with appropriate features that can be used in PIs. In addition to the wet-dry gauze dressing used in wound care from past to present, different care solutions are also used. 0.9% NaCl solutions are frequently used in wound care. Since 0.1% polyhexanide solution is also an effective antiseptic, we thought that its use in PI care would contribute to treatment management by determining its effect on wound healing.
- Conditions
- Pressure Injuries, Wound Care, Wound Cleansing
- Being tested
- 0.1% polyhexanide Care, 0.9 % NaCl Care
- Keywords
- pressure injury, %0.1 poliheksanit solution, %0.9 sodium chloride
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% polyhexanide CareOther
After the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.1% polyhexanide solution. Then, 2 treatments were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care and four follow-ups were performed.
0.9 % NaCl CareOther
After the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.9% sodium chloride. Then, 2 care sessions were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care sessions and four follow-ups were performed.
| Study group | Role | What they receive |
|---|---|---|
| 0.1% polyhexanide | Experimental | 0.1% polyhexanide solution was applied 3 times at 48-hour intervals for pressure ulcer care. Receives: Other: 0.1% polyhexanide Care |
| 0.9% NaCl | Experimental | 0.9% sodium chloride solution was applied three times at 48-hour intervals for pressure ulcer care. Receives: Other: 0.9 % NaCl Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PUSH score
This scale, developed by NPUAP to evaluate the healing process of pressure injuries, was used in the study to evaluate the healing status of pressure injuries in patients receiving pressure injury care. The pressure injury healing status was monitored with the evaluation criteria in the scale. The lowest score to be received from PUSH is 0, and the highest score is 17. A decrease in the score indicates that the pressure injury has healed.
Measured: From 0th hour to 144th hour
Secondary outcomes (1)
NPUAP Pressure Sore Classification System
Staging of pressure ulcers is important to assess the stage of the wound after it has formed to determine effective treatment methods. Staging indicates the severity of the pressure ulcer, its depth, the extent of skin affected, and the extent of tissue damage. The latest update was published by the NPUAP and EPUAP in 2009 as six stages.
Measured: 0th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Aug 2023
- Primary completion1 Jan 2024
- Study completion1 Aug 2024
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mensure Turan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mensure Turan, Şırnak Üniversitesi
- Investigators
- Mensure Turan, PhD, Principal investigator, Şırnak Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718777
- Sponsor's protocol ID
- 2023/39
- Status last verified
- Dec 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Solutions Used in Pressure Injury Care on Wound Healing Process
- ClinicalTrials.gov ID
- NCT06718777
- Acronym / sponsor ID
- 2023/39
- Conditions
- Pressure Injuries, Wound Care, Wound Cleansing
- Keywords
- pressure injury, %0.1 poliheksanit solution, %0.9 sodium chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Mensure TuranUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 5 Dec 2024 (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.
Pressure injuries are a condition that reduces patients' quality of life, increases hospitalization time and healthcare costs. When accompanied by infection and complications, mortality increases. The primary goal in pressure injuries is to prevent their occurrence, but once the injury has occurred, it is to provide effective and appropriate care. It is known that 0.9% sodium chloride (NaCl) is used routinely in pressure ulcer care. In addition, if the effectiveness of 0.1% polyhexanide in pressure ulcer care is demonstrated, it may provide data for its use in wound care. For this purpose, the study was completed as a randomized controlled trial with 32 individuals in the 0.1% polyhexanide group and 31 individuals in the 0.9% NaCl group, totaling 63 individuals.
Detailed description
The European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) defined pressure injury (PI) as "Local skin and/or subcutaneous tissue damage caused by pressure alone, or by a combination of pressure and shear, most often occurring over bony prominences". It has been stated that the prevalence of pressure ulcers varies between 0-72.5%, and that it is a condition that reduces the quality of life of patients, increases the length of hospital stay and health care costs. In particular, the accompanying infection and complications of PI cause increased mortality. The primary purpose of PIs is to prevent their occurrence and after the injury occurs, it is necessary to provide care with effective and appropriate methods. The determined method should have the feature that can contribute to wound healing. There are many products and methods with appropriate features that can be used in PIs. In addition to the wet-dry gauze dressing used in wound care from past to present, different care solutions are also used. 0.9% NaCl solutions are frequently used in wound care. Since 0.1% polyhexanide solution is also an effective antiseptic, we thought that its use in PI care would contribute to treatment management by determining its effect on wound healing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.1% polyhexanide | Experimental | Other: 0.1% polyhexanide Care0.1% polyhexanide solution was applied 3 times at 48-hour intervals for pressure ulcer care. |
| 0.9% NaCl | Experimental | Other: 0.9 % NaCl Care0.9% sodium chloride solution was applied three times at 48-hour intervals for pressure ulcer care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 who have developed pressure injuries
- Patients who have received informed consent from themselves or their guardians
Key exclusion criteria (3 listed)
- Patients with clotting problems
- Patients using corticosteroids
- Patients receiving additional medical treatment for wound care
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 |
|---|---|---|
| 0.1% polyhexanide CareAfter the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.1% polyhexanide solution. Then, 2 treatments were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care and four follow-ups were performed. | Other | 0.1% polyhexanide |
| 0.9 % NaCl CareAfter the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.9% sodium chloride. Then, 2 care sessions were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care sessions and four follow-ups were performed. | Other | 0.9% NaCl |
Primary outcome
PUSH score
Time frame: From 0th hour to 144th hour
This scale, developed by NPUAP to evaluate the healing process of pressure injuries, was used in the study to evaluate the healing status of pressure injuries in patients receiving pressure injury care. The pressure injury healing status was monitored with the evaluation criteria in the scale. The lowest score to be received from PUSH is 0, and the highest score is 17. A decrease in the score indicates that the pressure injury has healed.
1 secondary outcome
NPUAP Pressure Sore Classification System
Time frame: 0th hour
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 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Mensure Turan, PhD principal investigator
Şırnak Üniversitesi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.1% polyhexanide Care and 0.9 % NaCl Care in people with Pressure Injuries and Wound Care, run by Mensure Turan at 2 sites 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 2 inclusion and 3 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PUSH score (time frame: From 0th hour to 144th hour). 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 5 Dec 2024.