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The Effects of Topical Haemoglobin Spray in Pressure Ulcer

Investigation of the Effects of Topical Haemoglobin Wound Care Spray in Pressure Ulcer Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05915169
Enrollment
20
Registered
2023-06-22
Start date
2024-01-01
Completion date
2024-07-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer, Wound Heal

Keywords

pressure ulcer, nursing care, topical haemoglobin spray, wound dressing

Brief 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.

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.

Interventions

OTHERTopical haemoglobin wound care spray

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

Sponsors

Abant Izzet Baysal University
CollaboratorOTHER
Health Institutes of Turkey
CollaboratorOTHER_GOV
Bartın Unıversity
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

topical haemoglobin spray care group and standart gas dressing with saline solution care group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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.

Design outcomes

Primary

MeasureTime frameDescription
Pressure ulcer scale for healing2 monthsPUSH 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.

Secondary

MeasureTime frameDescription
cost chart2 monthsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026