The Effects of Topical Haemoglobin Spray in Pressure Ulcer

NCT05915169 | Completed

• 1 other identifier: AIBU-SBF-OU-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer; Wound Heal

Keywords

pressure ulcer; nursing care; topical haemoglobin spray; wound dressing

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer scale for healing

  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.

  2 months

Secondary Outcomes (1)

• cost chart

  2 months

Study Arms (2)

topical haemoglobin spray care group

EXPERIMENTAL

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

group of gas dressings with saline solution

NO INTERVENTION

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

Interventions

Topical haemoglobin wound care spray OTHER

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

topical haemoglobin spray care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bartın Unıversity: lead
• Abant Izzet Baysal University: collaborator
• Health Institutes of Turkey: collaborator

Study Sites (1)

Bartın Üniversitesi

Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Özge Uçar, Phd scholar

  Research Assisstant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: topical haemoglobin spray care group and standart gas dressing with saline solution care group

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)