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Completed

NCT Number: NCT05915169

The Effects of Topical Haemoglobin Spray in Pressure Ulcer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bartın Üniversitesi

Bartın, 74100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical haemoglobin wound care spray

Other

It is a wound care spray used in the care of chronic wounds.

Primary outcomes

  1. Pressure ulcer scale for healing

    Time frame: 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. The scores are rated from 0 to 10 according to the size of the wound.

Secondary outcomes

  1. cost chart

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bartın Unıversity

Other

Collaborators

  • Abant Izzet Baysal University
  • Health Institutes of Turkey

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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