The Effects of Topical Haemoglobin Spray in Pressure Ulcer

Study Overview
=================
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 stay, increase patient care costs, impair body image, prolong the healing process and many other negative effects. The European Pressure Ulcer Advisory Panel (EPUAP)/National Pressure Ulcer Advisory Panel (NPIAP)/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 population in the world and in our country, chronic diseases, comorbidity, palliative conditions. Therefore, our study was planned as a prospective randomised controlled experimental study 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.

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

Conditions
-----------------
Wound Heal, Pressure Ulcer

Intervention / Treatment
-----------------
* Other: Topical haemoglobin wound care spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be over 18 years of age, Normal albumin and protein levels, Stage 2 pressure ulcer, Blood glucose level is within normal limits, the consent of the patient himself or his guardian. Exclusion Criteria: being under 18 years of age, Pressure ulcers in areas other than the sacrum, Stage 1, Stage 3, Stage 4, unstageable pressure ulcers, Albumin and protein values are lower than normal, Blood glucose level is not within normal limits, the patient himself/herself or his/her guardian does not authorise it.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: topical haemoglobin spray care group and standart gas dressing with saline solution care group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical haemoglobin spray care group<br>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<br>* It is a wound care spray used in the care of chronic wounds.<br>|
| No Intervention: group of gas dressings with saline solution<br>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) | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pressure ulcer, nursing care, topical haemoglobin spray, wound dressing