Topical Honey as Adjunctive Therapy to Standard Dressing in Deep Neck Abscess: A Single-Blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Bacterial Colony
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Both patients and the principal investigator will remain blinded throughout the completed treatment period. Treatment allocations will only be disclosed after the final database lock. The patients are primarily handled by a principal investigator and resident doctor who is in charge of the evaluation of inclusion or exclusion criteria, adverse events, relapses, and side effects
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment Group (Standard Dressing and Honey)
In the treatment group, we combined standard procedures with the application of Nusantara Honey. A 120 cm gauze roll was soaked in a bowl containing 12 cc of Nusantara Honey for precisely 1 minute until saturation. Once the wound bed had risen sufficiently, the honey-soaked gauze was applied and covered with sterile gauze.
Intervention: Honey (Other)
Treatment Group (Standard Dressing and Honey)
In the treatment group, we combined standard procedures with the application of Nusantara Honey. A 120 cm gauze roll was soaked in a bowl containing 12 cc of Nusantara Honey for precisely 1 minute until saturation. Once the wound bed had risen sufficiently, the honey-soaked gauze was applied and covered with sterile gauze.
Intervention: PHMB Solution (Other)
Control Group (Standard Dressing)
The control group adhered to the established standard operating procedure (SOP) at the Larynx Pharynx subdivision of Dr. Sardjito Hospital. This protocol involved several steps of wound debridement, saline irrigation, gauze roll application, and Prontosan administration.
Intervention: PHMB Solution (Other)
Outcomes
Primary Outcomes
Bacterial Colony
Time Frame: Pus aspiration was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
Bacterial culture results and the number of bacterial colonies served as indicators of infection improvement. Swabs from the wound bed were sent to the Microbiology laboratory.
Wound Assessment
Time Frame: BWATs was measured on the first, seventh, and fourteenth days from abscess incision.
The wound was assessed by the research assistant using the Bates-Jensen Wound Assessment Tool
Cytokine and Growth Factor Expression
Time Frame: Tissue sampling was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
Immunopathological evaluation of wound healing involved tissue samples sent to the Anatomical Pathology laboratory for analysis of IL-1, TNF-α, and VEGF expression. Tissue sampling was performed using nasopharyngeal biopsy forceps, and the preserved tissue was sent for analysis.
Wound Measurements
Time Frame: The wound was measured on the first, seventh, and fourteenth days from abscess incision.
Wound measurements included length, width, and depth in cm, with the largest width and length used for data to report wound area in cm\^2. The wound depth was measured using a probe perpendicular to the wound's length and width.
Secondary Outcomes
- Kidney Function Tests(Kidney function tests were performed throughout patient's admission in the wards.)
- Blood Glucose Test(Blood glucose test was performed throughout patient's admission in the wards.)
- Vital Sign Examinations(Vital Signs were performed everyday throughout patient's admission in the wards.)
- Blood Gas Analysis(Blood gas analysis were performed throughout patient's admission in the wards.)
- Complete Blood Count (CBC)(CBC were performed throughout patient's admission in the wards.)
- Liver Function Tests(Liver function tests were performed throughout patient's admission in the wards.)
Investigators
DIAN PARAMITA WULANDARI
Principal Investigator
Gadjah Mada University