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The Effects of Topical Haemoglobin Spray in Pressure Ulcer

Primary Purpose

Pressure Ulcer, Wound Heal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical haemoglobin wound care spray
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pressure Ulcer focused on measuring pressure ulcer, nursing care, topical haemoglobin spray, wound dressing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    topical haemoglobin spray care group

    group of gas dressings with saline solution

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    June 13, 2023
    Sponsor
    Bartın Unıversity
    Collaborators
    Abant Izzet Baysal University, Health Institutes of Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05915169
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bartın Unıversity
    Collaborators
    Abant Izzet Baysal University, Health Institutes of Turkey

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pressure Ulcer, Wound Heal
    Keywords
    pressure ulcer, nursing care, topical haemoglobin spray, wound dressing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    topical haemoglobin spray care group and standart gas dressing with saline solution care group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    topical haemoglobin spray care group
    Arm Type
    Experimental
    Arm Description
    Patients with stage 2 pressure ulcers in the sacrum area will be treated with topical haemoglobin spray every 3 days for 2 months.
    Arm Title
    group of gas dressings with saline solution
    Arm Type
    No Intervention
    Arm Description
    Patients with stage 2 pressure ulcers in the sacrum area will receive routine saline gas dressing for 2 months.
    Intervention Type
    Other
    Intervention Name(s)
    Topical haemoglobin wound care spray
    Intervention Description
    It is a wound care spray used in the care of chronic wounds.
    Primary Outcome Measure Information:
    Title
    pressure ulcer scale for healing (PUSH)
    Description
    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.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    cost chart
    Description
    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.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özge Uçar, Phd scholar
    Phone
    +905458416296
    Email
    ozgeenginucar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arzu İlçe, Prof.
    Phone
    +905057760398
    Email
    arzuilce@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Özge Uçar, Phd scholar
    Organizational Affiliation
    Research Assisstant
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effects of Topical Haemoglobin Spray in Pressure Ulcer

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