The Effects of Topical Haemoglobin Spray in Pressure Ulcer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Heal; Pressure Ulcer
• Intervention / Treatment: Other: Topical haemoglobin wound care spray

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özge Uçar, Phd scholar; Phone Number: +905458416296; Email: ozgeenginucar@gmail.com
• Study Contact Backup: Name: Arzu İlçe, Prof.; Phone Number: +905057760398; Email: arzuilce@gmail.com

Study Locations

• Turkey
  • Bartın, Turkey, 74100
    • Recruiting
    • Bartın Üniversitesi
    • Contact: Sevim Çelik, dean; Phone Number: 5390 05327832989; Email: scelik@bartin.edu.tr
    • Principal Investigator: Özge Uçar, Phd
    • Principal Investigator: Arzu İlçe, Prof
    • Principal Investigator: Başak Erol Karagözoğlu, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; It is a wound care spray used in the care of chronic wounds.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bartın Unıversity
• Collaborators: Abant Izzet Baysal University; Health Institutes of Turkey
• Investigators: Principal Investigator: Özge Uçar, Phd scholar, Research Assisstant

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: nursing care; pressure ulcer; wound dressing; topical haemoglobin spray
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: AIBU-SBF-OU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No