Pressure UlcerNCT05915169
The Effects of Topical Haemoglobin Spray in Pressure Ulcer
A study testing Topical haemoglobin wound care spray in people with Pressure Ulcer and Wound Heal, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
A prospective randomised controlled experimental study was planned to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Wound Heal
- What is being tested?
- Topical haemoglobin wound care spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years of age,
- Normal albumin and protein levels,
- Stage 2 pressure ulcer,
- Blood glucose level is within normal limits,
- the consent of the patient himself or his guardian.
Who cannot join
- being under 18 years of age,
- Pressure ulcers in areas other than the sacrum,
- Stage 1, Stage 3, Stage 4, unstageable pressure ulcers,
- Albumin and protein values are lower than normal,
- Blood glucose level is not within normal limits,
- the patient himself/herself or his/her guardian does not authorise it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Topical Haemoglobin Wound Care Spray in Pressure Ulcer Care
A prospective randomised controlled experimental study was planned to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores.
Read the detailed description
Pressure sores are a serious health problem because they increase mortality, decrease quality of life, prolong hospital stays, increase patient care costs, impair body image, prolong the healing process, and have many other negative effects.
The European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPIAP), and Pan Pacific Pressure Ulcer Association (PPPIA) 2019 guidelines report that the prevalence of pressure ulcers in healthcare settings ranges from 10% to 72.5%, with large variations between different clinics and geographies. In the United States, the cost of pressure sore treatment to organisations is estimated to be $11 billion annually. Pressure sores will continue to be an important public health problem today and in the future, especially due to the increasing number of elderly people in the world and in our country, chronic diseases, comorbidity, and palliative conditions.
Therefore, the study was planned as a prospective randomised controlled experimental trial to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores.
- Conditions
- Pressure Ulcer, Wound Heal
- Being tested
- Topical haemoglobin wound care spray
- Keywords
- pressure ulcer, nursing care, topical haemoglobin spray, wound dressing
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical haemoglobin wound care sprayOther
It is a wound care spray used in the care of chronic wounds.
| Study group | Role | What they receive |
|---|---|---|
| topical haemoglobin spray care group | Experimental | Patients with stage 2 pressure ulcers in the sacrum area will be treated with topical haemoglobin spray every 3 days for 2 months. Receives: Other: Topical haemoglobin wound care spray |
| group of gas dressings with saline solution | No intervention | Patients with stage 2 pressure ulcers in the sacrum area will receive routine saline gas dressing for 2 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer scale for healing
PUSH is an acronym for Pressure Ulcer Scale for Healing. The National Pressure Ulcer Advisory Panel developed this tool to monitor pressure healing over time. The PUSH Tool monitors three parameters: surface area of the wound, wound exudate, and type of wound tissue. Wounds are measured using a centimeter ruler. The scores are rated from 0 to 10 according to the size of the wound.
Measured: 2 months
Secondary outcomes (1)
cost chart
The researcher has been formed by the researchers. The materials used for 2 months will be recorded in this table with their quantity. At the end of the study, cost calculation will be made based on current prices.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Model description
- topical haemoglobin spray care group and standart gas dressing with saline solution care group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University, Health Institutes of Turkey
- Responsible party
- Principal investigator, Özge Uçar, Bartın Unıversity
- Investigators
- Özge Uçar, Phd scholar, Principal investigator, Research Assisstant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915169
- Sponsor's protocol ID
- AIBU-SBF-OU-01
- Status last verified
- Aug 2024
- First submitted
- 13 Jun 2023
- Last updated
- 12 Aug 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Topical Haemoglobin Wound Care Spray in Pressure Ulcer Care
- ClinicalTrials.gov ID
- NCT05915169
- Acronym / sponsor ID
- AIBU-SBF-OU-01
- Conditions
- Pressure Ulcer, Wound Heal
- Keywords
- pressure ulcer, nursing care, topical haemoglobin spray, wound dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University, Health Institutes of Turkey
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 22 Jun 2023 (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.
A prospective randomised controlled experimental study was planned to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores.
Detailed description
Pressure sores are a serious health problem because they increase mortality, decrease quality of life, prolong hospital stays, increase patient care costs, impair body image, prolong the healing process, and have many other negative effects.
The European Pressure Ulcer Advisory Panel (EPUAP), National Pressure Ulcer Advisory Panel (NPIAP), and Pan Pacific Pressure Ulcer Association (PPPIA) 2019 guidelines report that the prevalence of pressure ulcers in healthcare settings ranges from 10% to 72.5%, with large variations between different clinics and geographies. In the United States, the cost of pressure sore treatment to organisations is estimated to be $11 billion annually. Pressure sores will continue to be an important public health problem today and in the future, especially due to the increasing number of elderly people in the world and in our country, chronic diseases, comorbidity, and palliative conditions.
Therefore, the study was planned as a prospective randomised controlled experimental trial to compare the effects of pressure sore dressing using topical haemoglobin and traditional gauze dressing using saline on the healing process and cost of pressure sores in patients with pressure sores.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- topical haemoglobin spray care group and standart gas dressing with saline solution care group
| Arm | Type | Receives |
|---|---|---|
| topical haemoglobin spray care group | Experimental | Other: Topical haemoglobin wound care sprayPatients with stage 2 pressure ulcers in the sacrum area will be treated with topical haemoglobin spray every 3 days for 2 months. |
| group of gas dressings with saline solution | No intervention | –Patients with stage 2 pressure ulcers in the sacrum area will receive routine saline gas dressing for 2 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be over 18 years of age,
- Normal albumin and protein levels,
- Stage 2 pressure ulcer,
- Blood glucose level is within normal limits,
- the consent of the patient himself or his guardian.
Key exclusion criteria (6 listed)
- being under 18 years of age,
- Pressure ulcers in areas other than the sacrum,
- Stage 1, Stage 3, Stage 4, unstageable pressure ulcers,
- Albumin and protein values are lower than normal,
- Blood glucose level is not within normal limits,
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 |
|---|---|---|
| Topical haemoglobin wound care sprayIt is a wound care spray used in the care of chronic wounds. | Other | topical haemoglobin spray care group |
Primary outcome
Pressure ulcer scale for healing
Time frame: 2 months
PUSH is an acronym for Pressure Ulcer Scale for Healing. The National Pressure Ulcer Advisory Panel developed this tool to monitor pressure healing over time. The PUSH Tool monitors three parameters: surface area of the wound, wound exudate, and type of wound tissue. Wounds are measured using a centimeter ruler. The scores are rated from 0 to 10 according to the size of the wound.
1 secondary outcome
cost chart
Time frame: 2 months
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 12 Aug 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.
Özge Uçar, Phd scholar principal investigator
Research Assisstant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical haemoglobin wound care spray in people with Pressure Ulcer and Wound Heal, run by Bartın Unıversity 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 5 inclusion and 6 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 12 Aug 2024. 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?
Pressure ulcer scale for healing (time frame: 2 months). 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 12 Aug 2024.