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CompletedNCT05915169Updated Aug 12, 2024

The Effects of Topical Haemoglobin Spray in Pressure Ulcer

An interventional study of Topical haemoglobin wound care spray in Pressure Ulcer and Wound Heal, sponsored by Bartın Unıversity. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Bartın Unıversity · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pressure Ulcer
  • Wound Heal

Keywords

  • pressure ulcer
  • nursing care
  • topical haemoglobin spray
  • wound dressing
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Bartın Unıversity is the lead sponsor of 45 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. be over 18 years of age,
  2. Normal albumin and protein levels,
  3. Stage 2 pressure ulcer,
  4. Blood glucose level is within normal limits,
  5. the consent of the patient himself or his guardian.

Exclusion criteria

Exclusion Criteria:

  1. being under 18 years of age,
  2. Pressure ulcers in areas other than the sacrum,
  3. Stage 1, Stage 3, Stage 4, unstageable pressure ulcers,
  4. Albumin and protein values are lower than normal,
  5. Blood glucose level is not within normal limits,
  6. the patient himself/herself or his/her guardian does not authorise it.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    topical haemoglobin spray care group

    Patients with stage 2 pressure ulcers in the sacrum area will be treated with topical haemoglobin spray every 3 days for 2 months.

    Other: Topical haemoglobin wound care spray

  • No intervention
    group of gas dressings with saline solution

    Patients with stage 2 pressure ulcers in the sacrum area will receive routine saline gas dressing for 2 months.

Interventions

  • OtherTopical haemoglobin wound care spray

    It is a wound care spray used in the care of chronic wounds.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 2 months

07

Study locations

1 site
  • Bartın Üniversitesi
    Bartın, 74100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05915169
Lead sponsor
Bartın Unıversity
Collaborators
Abant Izzet Baysal University, Health Institutes of Turkey
Responsible party
Özge Uçar (Research Assistant, Bartın Unıversity) — Principal investigator
First posted
Jun 22, 2023
Start date
Jan 1, 2024
Primary completion
Jun 30, 2024
Completion
Jul 30, 2024
Last update
Aug 12, 2024

Study contacts

Özge Uçar, Phd scholar
principal investigator · Research Assisstant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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