Clinical trial NCT03641053: Honey Versus Povidone-iodine on Laceration Wounds
Official title: Comparison of Honey and Povidone-iodine in Wound Healing on Acute Laceration Wounds: A Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laceration Face
Wound Heal
Wounds and Injuries
Laceration Arm
Laceration of Leg
Keywords: honey
povidone-iodine
randomized control trial
wound healing
Lead sponsor: S.K. Lerik General Hospital
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm parallel assignment where one group receives honey, the second group receives povidone-iodine, and the third group receives paraffin gauze as wound dressing.
Primary purpose: TREATMENT

Brief summary: This study evaluates healing time in usage of honey and povidone-iodine over paraffin gauze as dressings in the treatment of acute laceration wounds. In Indonesia, especially in rural area, where most of the resources is limited and modern dressings are expensive and hard-to-find. The investigators tried to find an alternative which was easier to find and could act as a substitute of modern wound dressing.

The hypothesis of this study is honey and povidone-iodine could be a good substitute (or equal to) to paraffin gauze on acute laceration wounds.

Honey is chosen because of its versatility and already well-known to be used as a chronic wound dressing. Povidone-iodine was chosen as another alternative because it is still one of the most used substance in rural area as a wound dressing, but there is not enough study to support the usage of this substance. Paraffin gauze was chosen as a representative of modern wound dressing because it fulfilled the standard of wound dressing on acute wound, which is non-adherent and also moist.

Detailed description: The investigator's team consists of five members, each have their own specific tasks and divided by two groups, which are ER group (first time encounter, informed consent, and intervention) and polyclinic group (routine wound care). All of the data are primary data. Data registry were taken by the team without involving any other party. Any intervention done to the participants were also done only by the team(suturing, wound care). Appointment for routine wound care was also made by contacting the participant through their cellphone numbers which were collected when they come to the ER.

The data of each of the participant was registered on a form which was pre-made by the investigators. It recorded the identity of the patient, history taking, physical examination, and also to record more detailed information about our intervention, such as the amount of stitches and how many and what kind of resources that have been spent on the participant.

Every sample will be categorized into 3 randomized groups of intervention; honey, povidone-iodine, and paraffin gauze, which will also be categorized by location of their wound; face and neck, upper extremity, and lower extremity. Participants on each intervention group are distributed evenly using stratified block randomization. Photos of the wound will be taken before and after the wound is cleaned, and after the wound has been sutured. Every patient will be asked to attend a predetermined schedule for wound care assessment. The wound will be evaluated by photos before and after the wound is cleaned, debrided, or have its sutures removed. Parameter of evaluation will be duration of wound healing per anatomical region, infection, cleanliness of wound, odor, exudate level, pain, itch, and total cost of wound care.

Every paper consists of participants' data that were collected on colored maps based on the intervention group (red: povidone-iodine, yellow: honey, blue: paraffin). At the end of the study, three of the team's members converted the data to be analyzed using Microsoft Excel and SPSS.

The investigators prepared beforehand the Standard Operational Procedures regarding any possibilities of adverse events, such as lidocaine toxicity and honey hypersensitivity and were already approved by the hospital's committee.

The investigators determined the target of the sample size with the total sample of 36 participants, distributed evenly based on intervention groups and wounds' location using stratified block randomization

Eligibility criteria: Inclusion Criteria:

Every patient that admits to the emergency department with:

* An acute open traumatic wound
* Agrees to a voluntary agreement for informed consent
* To be treated in an outpatient setting

Exclusion Criteria:

Human factor:

* Patient under the age of 10 and over 60 years old
* Systemic conditions (diabetes mellitus, hypertension, liver' kidney disease)
* Signs of infection
* Consuming steroids and / or antibiotics
* History of keloid
* History of drug and / or alcohol abuse
* Under treatment for chemotherapy or immunocompromised
* Pregnant
* History of allergy towards amoxicillin and / or ibuprofen

Wound factor:

* Acute Open Traumatic Wound that has occured after than 12 hours of admittance to the emergency department
* Open fracture
* Suspicion of contamination from the mechanism of attaining the wound (human or animal bite, body fluids such as faeces, saliva, urine, sperm, or vaginal secretion)
* Penetration trauma (stab wound, gunshot wound, or a joint-affected wound)
* Signs of wound infection
* More than one wound in the same anatomical region
* Possess a chronic wound caused by underlying disease other than trauma
* Wound with exposed tendon and/ or bone
* Wound length dimension no less than 1 cm and no more than 10 cm.
* Hypersensitivity to honey
* Does not attend to scheduled wound care assesment control
* Sample's wish to not be involved anymore with the research at any phase

Primary outcomes:
measure: Wound healing time
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
Secondary outcomes:
measure: Infection
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
measure: Pain level
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
measure: Itchiness
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
measure: Odor
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
measure: Exudate
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
measure: Cleanliness
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
measure: Cost
timeFrame: 28 days/4 weeks; day 0 is the day of the event. The participants was chosen very carefully by our strict eligibility criteria, so the investigators expect that the wound will heal on acute period
Other outcomes:
Locations:
city: Kupang
country: Indonesia
facility: S.K. Lerik General Hospital
state: East Nusa Tenggara
Study officials:
name: Kevin L Suryadinata, MD
role: PRINCIPAL_INVESTIGATOR
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