Effect of Two Different Solutions on Wound Healing in Pressure Injury

Not Applicable

Completed

• Conditions: Pressure Injuries; Wound Care; Wound Cleansing

• Registration Number: NCT06718777
• Lead Sponsor: Mensure Turan

Brief Summary

Pressure injuries are a condition that reduces patients' quality of life, increases hospitalization time and healthcare costs. When accompanied by infection and complications, mortality increases. The primary goal in pressure injuries is to prevent their occurrence, but once the injury has occurred, it is to provide effective and appropriate care. It is known that 0.9% sodium chloride (NaCl) is used routinely in pressure ulcer care. In addition, if the effectiveness of 0.1% polyhexanide in pressure ulcer care is demonstrated, it may provide data for its use in wound care. For this purpose, the study was completed as a randomized controlled trial with 32 individuals in the 0.1% polyhexanide group and 31 individuals in the 0.9% NaCl group, totaling 63 individuals.

Detailed Description

The European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) defined pressure injury (PI) as "Local skin and/or subcutaneous tissue damage caused by pressure alone, or by a combination of pressure and shear, most often occurring over bony prominences". It has been stated that the prevalence of pressure ulcers varies between 0-72.5%, and that it is a condition that reduces the quality of life of patients, increases the length of hospital stay and health care costs. In particular, the accompanying infection and complications of PI cause increased mortality. The primary purpose of PIs is to prevent their occurrence and after the injury occurs, it is necessary to provide care with effective and appropriate methods. The determined method should have the feature that can contribute to wound healing. There are many products and methods with appropriate features that can be used in PIs. In addition to the wet-dry gauze dressing used in wound care from past to present, different care solutions are also used. 0.9% NaCl solutions are frequently used in wound care. Since 0.1% polyhexanide solution is also an effective antiseptic, we thought that its use in PI care would contribute to treatment management by determining its effect on wound healing.

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-08-01
• Study First Submitted: 2024-11-04
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Patients over the age of 18 who have developed pressure injuries
• Patients who have received informed consent from themselves or their guardians

Exclusion Criteria

• Patients with clotting problems
• Patients using corticosteroids
• Patients receiving additional medical treatment for wound care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PUSH score	From 0th hour to 144th hour	This scale, developed by NPUAP to evaluate the healing process of pressure injuries, was used in the study to evaluate the healing status of pressure injuries in patients receiving pressure injury care. The pressure injury healing status was monitored with the evaluation criteria in the scale. The lowest score to be received from PUSH is 0, and the highest score is 17. A decrease in the score indicates that the pressure injury has healed.

Secondary Outcome Measures

Name	Time	Method
NPUAP Pressure Sore Classification System	0th hour	Staging of pressure ulcers is important to assess the stage of the wound after it has formed to determine effective treatment methods. Staging indicates the severity of the pressure ulcer, its depth, the extent of skin affected, and the extent of tissue damage. The latest update was published by the NPUAP and EPUAP in 2009 as six stages.

Trial Locations

Locations (1)

Gazi Yaşargil Training and Research Hospital; 🇹🇷 Diyarbakır, Turkey