Effect of Two Different Solutions on Wound Healing in Pressure Injury

NCT06718777 | Completed

• 1 other identifier: 2023/39
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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.

Conditions

Pressure Injuries; Wound Care; Wound Cleansing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PUSH score

  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.

  From 0th hour to 144th hour

Secondary Outcomes (1)

• NPUAP Pressure Sore Classification System

  0th hour

Study Arms (2)

0.1% polyhexanide

EXPERIMENTAL

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

Other: 0.1% polyhexanide Care

0.9% NaCl

EXPERIMENTAL

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

Other: 0.9 % NaCl Care

Interventions

0.1% polyhexanide Care 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.

0.1% polyhexanide

0.9 % NaCl Care 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.

0.9% NaCl

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mensure Turan: lead

Study Sites (2)

Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21000, Turkey (Türkiye)

Location

Gazi Yaşargil Training and Research Hospital

Diyarbakır, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mensure Turan, PhD

  Şırnak Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 5, 2024
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)