Effect of Two Different Solutions on Wound Healing in Pressure Injury

NCT ID: NCT06718777

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-01

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.

Conditions

Pressure Injuries; Wound Care; Wound Cleansing

Keywords

pressure injury; %0.1 poliheksanit solution; %0.9 sodium chloride

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

0.1% polyhexanide

0.1% polyhexanide solution was applied 3 times at 48-hour intervals for pressure ulcer care.

Group Type: EXPERIMENTAL

0.1% polyhexanide Care

Intervention Type: OTHER

After the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.1% polyhexanide solution. Then, 2 treatments were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care and four follow-ups were performed.

0.9% NaCl

0.9% sodium chloride solution was applied three times at 48-hour intervals for pressure ulcer care.

Group Type: EXPERIMENTAL

0.9 % NaCl Care

Intervention Type: OTHER

After the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.9% sodium chloride. Then, 2 care sessions were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care sessions and four follow-ups were performed.

Interventions

0.1% polyhexanide Care

After the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.1% polyhexanide solution. Then, 2 treatments were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care and four follow-ups were performed.

Intervention Type: OTHER

0.9 % NaCl Care

After the patient was randomized for pressure ulcer care, data were recorded at the first follow-up before care and pressure ulcer care was performed with 0.9% sodium chloride. Then, 2 care sessions were performed at 48-hour intervals and PUSH scores were recorded before each care. A total of three pressure ulcer care sessions and four follow-ups were performed.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mensure Turan

OTHER

Sponsor Role: lead

Responsible Party

Mensure Turan

Asistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mensure Turan, PhD

Role: PRINCIPAL_INVESTIGATOR

Şırnak Üniversitesi

Locations

Gazi Yaşargil Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Gazi Yaşargil Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/39

Identifier Type: -

Identifier Source: org_study_id