The Effects of Topical Haemoglobin Spray in Pressure Ulcer

Sponsor
Bartın Unıversity (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05915169
Collaborator
Abant Izzet Baysal University (Other), Health Institutes of Turkey (Other)
18
2
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Topical haemoglobin wound care spray
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
topical haemoglobin spray care group and standart gas dressing with saline solution care grouptopical haemoglobin spray care group and standart gas dressing with saline solution care group
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Investigation of the Effects of Topical Haemoglobin Wound Care Spray in Pressure Ulcer Care
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. pressure ulcer scale for healing (PUSH) [2 months]

    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

  1. cost chart [2 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bartın Unıversity
  • Abant Izzet Baysal University
  • Health Institutes of Turkey

Investigators

  • Principal Investigator: Özge Uçar, Phd scholar, Research Assisstant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Özge Uçar, Research Assistant, Bartın Unıversity
ClinicalTrials.gov Identifier:
NCT05915169
Other Study ID Numbers:
  • AIBU-SBF-OU-01
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Özge Uçar, Research Assistant, Bartın Unıversity
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023