Honey Versus Povidone-iodine on Laceration Wounds (NCT03641053) | Clinical Trial Compass
CompletedPhase 3
Honey Versus Povidone-iodine on Laceration Wounds
Indonesia35 participantsStarted 2018-01-29
Plain-language 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.
Who can participate
Age range
10 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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