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Completed

NCT Number: NCT06562257

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

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.

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Key information

Conditions

Neck Abscess

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sardjito General Hospital

Yogyakarta, D.I Yogyakarta, 55281, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Honey

Other

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

PHMB Solution

Other

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

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 .

  6. 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

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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