Effect of Solutions Used in Burn Wound Irrigation on Healing, Pain, Fear and Anxiety: Randomized Controlled Study

NCT06941571 | Not Yet Recruiting

• 2 other identifiers: 20.07.2023/111742497
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

Burn, skin and/or subcutaneous tissues; It is an acute injury that causes traumatic lesions by exposure to thermal, chemical, mechanical or electrical agents. Among all traumatic injuries, burns are the most common type of injury and affect the entire body system. The World Health Organization reports that approximately 180,00 deaths per year are due to burns, making it the fifth most common type of childhood injury. It is also stated that 80% of burned children have hot water burns. Treatment is in two ways: surgical and non-surgical. The type of burn, its size, depth and the individual characteristics of the child affect the type of treatment. Non-surgical treatment is always the first choice in burn treatment. The primary method of this method is burn dressings. Before dressing, the burn surface must be cleaned/irrigated with an appropriate antiseptic solution to remove metabolic wastes and tissue exudate. The aim here is to prepare a suitable environment for the burn wound to heal and to accelerate the healing process. In the literature, it is recommended to use various antiseptic solutions such as 0.9% NaCl, 0.5% chlorhexidine and hypochlorous acid for irrigation of burn wounds. Applying these solutions involves physical contact with the wound, and this contact may cause pain in the child. Additionally, the temperature and pH of the solution may cause discomfort. The pain that occurs during the irrigation process can further intensify anxiety and fear. However, it is not known which burn solutions used cause more pain, anxiety and fear. In this project, the effects of irrigation solutions used in the care of pediatric burn wounds on pain, fear, anxiety, infection development and healing will be examined. Child patients aged 5-10 years old with limb burns who present with hot water burns and do not have an indication for hospitalization will be included in the project. Children coming to burn dressing will be divided into three groups by simple randomization method. The burn wound of children in the first group will be irrigated with 0.09% NaCl, the children in the second group will be irrigated with 0.5% chlorhexidine, and the burn wound of children in the third group will be irrigated with hypochlorous acid solution. During irrigation of the burn wound, the child's anxiety, fear and pain status will be evaluated. At the same time, the effectiveness of the irrigation solutions used on the development of infection on the wound and its effectiveness on healing will be examined. For this reason, the burn wound will be monitored every three days. For this reason, children will be called to the burn clinic for dressing every three days. Before each dressing, a wound swab sample will be taken to determine the infection status in the burn wound. The Bates-Jensen wound assessment tool will be used to determine the healing status of the burn wound, and this tool will be evaluated by the burn nurse and two pediatric surgeons. In total, children will be monitored for 12 days. At the end of the project, the effect of the solutions used in burn irrigation on infection and healing will be determined. At the same time, the effects of the solutions on anxiety, fear and pain in children will be evaluated. It is thought that the data obtained as a result of the project will contribute to the development of a burn wound care protocol.

Conditions

Burn; Burn Wound; Healing; Pain; Anxiety; Fear

Outcome Measures

Primary Outcomes (3)

• Wong-Baker Facial Expression Rating Scale Score

  The effects of different irrigation solutions on pain will be measured.

  4 months

• Child Fear Scale Score

  The effects of different irrigation solutions on fear will be measured..

  4 months

• Child State Anxiety Scale Score

  The effects of different irrigation solutions on anxiety will be measured..

  4 months

Study Arms (3)

Control group

NO INTERVENTION

In this group, burn wounds will be washed with irrigation solution in accordance with the clinical care protocol (%0.09 NaCl).

Active Comparator 1

ACTIVE COMPARATOR

In this group, burn wounds will be washed with hypochlorous acid irrigation solution.

Other: Irrigation Solution

Active Comparator 2

ACTIVE COMPARATOR

In this group, burn wounds will be washed with chlorhexidine gluconate irrigation solution.

Other: Irrigation Solution

Interventions

Irrigation Solution OTHER

In this group, the effects of washing burn wounds with different irrigation solutions will be investigated.

Active Comparator 1; Active Comparator 2

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Nurdan AKCAY DİDİSEN: lead
• Health Institutes of Turkey: collaborator

MeSH Terms

Conditions

Burns; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Nurdan AKCAY DİDİŞEN

CONTACT

00902323115561; nakcayyy@gmail.com

Orkan ERGUN

CONTACT

orkan.ergun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Burn intervention will be performed by the burn clinic nurse. In this project, the participants who will receive burn dressing, the project manager, project researchers and the statistician who will evaluate the study results will remain blind.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Before data collection, the materials required for the intervention will first be provided. A preliminary application phase will be carried out with six more children. After the use of the data collection tools after the preliminary application, a pre-test measurement will be made for the intervention groups, photographs will be taken and a wound swab sample will be taken. After this shooting, the burn wound will be irrigated and the wound will be covered with a hydrophilic dressing. Three days after the intervention, the children will be called for dressing again. The burn wound will be photographed again and a wound swab sample will be taken. Irrigation will be applied again. With this monitoring, the children will be monitored for 12 days with regular appointments, four times. In the final phase, the burn areas whose photographs were taken will be sent to specialists and they will be asked to make burn area evaluations using the Bates-Jansen wound assessment form.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 24, 2025
• Study Start: September 30, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share