The Effects of Topical Haemoglobin Spray in Pressure Ulcer

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915169
• Other study ID #: AIBU-SBF-OU-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Bartin University
• Contact: Özge Uçar, Phd scholar
• Phone: +905458416296
• Email: ozgeenginucar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer
• Wound Heal

Intervention

Other:
• Topical haemoglobin wound care spray
It is a wound care spray used in the care of chronic wounds.

Locations

Country	Name	City	State
Turkey	Bartin Üniversitesi	Bartin

Sponsors (3)

Lead Sponsor	Collaborator
Bartin University	Abant Izzet Baysal University, Health Institutes of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Secondary	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.	2 months