The Effects of Topical Haemoglobin Spray in Pressure Ulcer

Bartın Unıversity

Status: Completed

Conditions: Pressure Ulcer; Wound Heal

Treatments: Other: Topical haemoglobin wound care spray

Study type: Interventional

Funder types: Other

Identifiers

NCT05915169

AIBU-SBF-OU-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

topical haemoglobin spray care group

Experimental group

Description:

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

Treatment:

Other: Topical haemoglobin wound care spray

group of gas dressings with saline solution

No Intervention group

Description:

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