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

June 4, 2026 updated by: DIAN PARAMITA WULANDARI, Gadjah Mada University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • D.I Yogyakarta
      • Yogyakarta, D.I Yogyakarta, Indonesia, 55281
        • Dr. Sardjito General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Honey
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.
Other Names:
  • Nusantara Honey
Other: PHMB 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.
Other Names:
  • Prontosan
Active Comparator: 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.
Other: PHMB 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.
Other Names:
  • Prontosan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
BWATs was measured on the first, seventh, and fourteenth days from abscess incision.
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.
The wound was measured on the first, seventh, and fourteenth days from abscess incision.
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.
Pus aspiration was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
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.
Tissue sampling was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital Sign Examinations
Time Frame: Vital 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.
Vital Signs were performed everyday throughout patient's admission in the wards.
Blood Gas Analysis
Time Frame: Blood 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.
Blood gas analysis were performed throughout patient's admission in the wards.
Complete Blood Count (CBC)
Time Frame: 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.
CBC were performed throughout patient's admission in the wards.
Liver Function Tests
Time Frame: Liver 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.
Liver function tests were performed throughout patient's admission in the wards.
Kidney Function Tests
Time Frame: Kidney 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 .
Kidney function tests were performed throughout patient's admission in the wards.
Blood Glucose Test
Time Frame: Blood 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
Blood glucose test was performed throughout patient's admission in the wards.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Investigators

  • Principal Investigator: Dian Paramita Wulandari, Universitas Gadjah Mada - Dr. Sardjito General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE/FK/0668/EC/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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