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Honey as an Adjunctive Wound Care Modality for Deep Neck Space Abscess

Topical Honey as Adjunctive Therapy to Standard Dressing in Deep Neck Abscess: A Single-Blind Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06562257
Enrollment
36
Registered
2024-08-20
Start date
2024-06-19
Completion date
2025-12-31
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Abscess

Keywords

Deep neck space infection, Deep neck space abscess, Wound healing, Honey dressing, Bates Jensen Wound Assessment Tool

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.

Interventions

OTHERHoney

Honey has a long-standing reputation for promoting wound healing and offers a more economical treatment modality. Nusantara Honey, a GMP-certified product available on the market, met our criteria for quality and safety.

OTHERPHMB Solution

PHMB is an antimicrobial polymer that is effective against intracellular and biofilm forms of S. aureus. PHMB is quite effective in the treatment of wounds in deep neck abscesses.

Sponsors

Gadjah Mada University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Wound AssessmentBWATs 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
Wound MeasurementsThe 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.
Bacterial ColonyPus aspiration was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incisionBacterial 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.
Cytokine and Growth Factor ExpressionTissue sampling was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incisionImmunopathological 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.

Secondary

MeasureTime frameDescription
Vital Sign ExaminationsVital Signs were performed everyday throughout patient's admission in the wards.Vital signs consist of blood pressure (mmHg), heart rate per minute, respiration rate per minute, temperature (°C), and saturation (%) which are useful for monitoring patients in this study.
Blood Gas AnalysisBlood gas analysis were performed throughout patient's admission in the wards.Blood gas analysis showed by measuring pH, pCO2 (mmHg), HCO3 (mmol/L), pO2 (mmHg), and BE (mmol/L) status.
Complete Blood Count (CBC)CBC were performed throughout patient's admission in the wards.Complete blood count performed included, Hemoglobin (g/dL), RBC (10\^6/uL), WBC (10\^3/uL), Platelet (10\^3/uL), and blood type.
Liver Function TestsLiver function tests were performed throughout patient's admission in the wards.Liver function tests typically include SGOT (U/L), SGPT (U/L), bilirubin serum (mg/dL), INR (international normalized ratio), prothrombin time (PT) and activated partial thromboplastine time (APTT) in second.
Kidney Function TestsKidney function tests were performed throughout patient's admission in the wards.Kidney function test such as albumin (g/dL), BUN (mg/dl), creatinine serum (mg/dL), uric acid (mg/dL) and electrolytes (mmol/L): sodium, potassium, chloride .
Blood Glucose TestBlood glucose test was performed throughout patient's admission in the wards.A blood glucose test measure the amount of glucose in patient blood to hel diagnose or monitor diabetes either as a comorbidity or not ny doing a finger-picker test or a blood draw from patient vein

Countries

Indonesia

Contacts

PRINCIPAL_INVESTIGATORDian Paramita Wulandari

Universitas Gadjah Mada - Dr. Sardjito General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026