Clinical trial NCT06562257: Honey as A Wound Care Modality in Treating Deep Neck Space Abscess
Official title: Honey as A Wound Care Modality in Treating Deep Neck Space Abscess: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Abscess
Keywords: Deep neck space infection
Deep neck space abscess
Wound healing
Honey dressing
Bates Jensen Wound Assessment Tool
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of honey as a treatment for deep neck space abscesses, comparing it to standard wound care methods. Conducted as a randomized clinical trial, it aims to determine whether honey can offer a viable alternative or improvement in managing this condition. The research assesses outcomes related to healing, infection control, and overall patient recovery.

Detailed description: Deep neck abscess is one of the diseases in the field of otorhinolaryngology-head and neck surgery that has high morbidity, mortality, and costs. Management of deep neck abscesses involves incision and drainage, abscess exploration, systemic administration of broad-spectrum antibiotics, management of comorbid factors, and postoperative wound care until healing. Standard dressing for wound care has been time-consuming and costly. Honey is one type of dressing modality that has been widely used in wound care for various parts of the body and diseases. Honey is expected to be a more cost-efficient treatment modality that supports accelerated wound healing, leading to better outcomes and cost savings.

The research design used is a single-blind randomized controlled trial (RCT), where researchers randomly assign one intervention to respondents to compare the effects of honey and Prontosan on the wound healing process. The population and sample of the study include all patients with deep neck abscesses treated at Dr. Sardjito General Hospital, the teaching hospital of the Faculty of Medicine Gadjah Mada University and other hospitals equipped with board-certified Otorhinolaryngologists. The participants in the control group were treated with standard dressing, while participants in the study group were treated with standard dressing along with honey dressing.

Eligibility criteria: Inclusion Criteria:

* Deep neck abscess patients over 18 years old with or without comorbidities except for malignant diseases

Exclusion Criteria:

* Patients who refused intervention
* Patients who underwent vacuum-assisted closure (VAC)
* Patients with incomplete medical records

Primary outcomes:
measure: Wound Assessment
timeFrame: BWATs was measured on the first, seventh, and fourteenth days from abscess incision.
measure: Wound Measurements
timeFrame: The wound was measured on the first, seventh, and fourteenth days from abscess incision.
measure: Bacterial Colony
timeFrame: Pus aspiration was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
measure: Cytokine and Growth Factor Expression
timeFrame: Tissue sampling was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
Secondary outcomes:
measure: Vital Sign Examinations
timeFrame: Vital Signs were performed everyday throughout patient's admission in the wards.
measure: Blood Gas Analysis
timeFrame: Blood gas analysis were performed throughout patient's admission in the wards.
measure: Complete Blood Count (CBC)
timeFrame: CBC were performed throughout patient's admission in the wards.
measure: Liver Function Tests
timeFrame: Liver function tests were performed throughout patient's admission in the wards.
measure: Kidney Function Tests
timeFrame: Kidney function tests were performed throughout patient's admission in the wards.
measure: Blood Glucose Test
timeFrame: Blood glucose test was performed throughout patient's admission in the wards.
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Dr. Sardjito General Hospital
state: D.I Yogyakarta
Study officials:
affiliation: Universitas Gadjah Mada - Dr. Sardjito General Hospital
name: Dian Paramita Wulandari
role: PRINCIPAL_INVESTIGATOR
References: