Clinical trial NCT05915169: The Effects of Topical Haemoglobin Spray in Pressure Ulcer
Official title: Investigation of the Effects of Topical Haemoglobin Wound Care Spray in Pressure Ulcer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Wound Heal
Keywords: pressure ulcer
nursing care
topical haemoglobin spray
wound dressing
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
Collaborators: name: Abant Izzet Baysal University
name: Health Institutes of Turkey
First posted: 2023-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: topical haemoglobin spray care group and standart gas dressing with saline solution care group
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pressure ulcer scale for healing
timeFrame: 2 months
Secondary outcomes:
measure: cost chart
timeFrame: 2 months
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın Üniversitesi
Study officials:
affiliation: Research Assisstant
name: Özge Uçar, Phd scholar
role: PRINCIPAL_INVESTIGATOR
References: