Clinical trial NCT06718777: Effect of Two Different Solutions on Wound Healing in Pressure Injury
Official title: Effect of Two Different Solutions Used in Pressure Injury Care on Wound Healing Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injuries
Wound Care
Wound Cleansing
Keywords: pressure injury
%0.1 poliheksanit solution
%0.9 sodium chloride
Lead sponsor: Şırnak Üniversitesi
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: PUSH score
timeFrame: From 0th hour to 144th hour
Secondary outcomes:
measure: NPUAP Pressure Sore Classification System
timeFrame: 0th hour
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Gazi Yaşargil Training and Research Hospital
city: Diyarbakır
country: Turkey
facility: Gazi Yaşargil Training and Research Hospital
Study officials:
affiliation: Şırnak Üniversitesi
name: Mensure Turan, PhD
role: PRINCIPAL_INVESTIGATOR
References: