The Effects of Topical Haemoglobin Spray in Pressure Ulcer

NCT ID: NCT05915169

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Pressure Ulcer Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

topical haemoglobin spray care group and standart gas dressing with saline solution care group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Topical haemoglobin wound care spray

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Topical haemoglobin wound care spray

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role collaborator

Health Institutes of Turkey

OTHER_GOV

Sponsor Role collaborator

Bartın Unıversity

OTHER

Sponsor Role lead

Responsible Party

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Özge Uçar

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özge Uçar, Phd scholar

Role: PRINCIPAL_INVESTIGATOR

Research Assisstant

Locations

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Bartın Üniversitesi

Bartın, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AIBU-SBF-OU-01

Identifier Type: -

Identifier Source: org_study_id

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