Laceration FacePhase 3NCT03641053
Honey Versus Povidone-iodine on Laceration Wounds
A Phase 3 study testing Honey, Povidone-iodine and Paraffin gauze in people with Laceration Face and Wound Heal, run by S.K. Lerik General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Laceration Face, Wound Heal, Wounds and Injuries
- What is being tested?
- Honey, Povidone-iodine and Paraffin gauze
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Jan 2018to 30 Jun 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
S.K. Lerik General Hospital
Kupang, East Nusa Tenggara, 85227
About this study
Official title: Comparison of Honey and Povidone-iodine in Wound Healing on Acute Laceration Wounds: A Randomized Controlled Trial Study
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.
Read the 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
- Being tested
- Honey, Povidone-iodine, Paraffin gauze
- Keywords
- honey, povidone-iodine, randomized control trial, wound healing
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyOther
Also called Madu Nusantara®
Substance is given topically after the wound has been sutured
Povidone-iodineOther
Also called OneMed® povidone-iodine 10%
Substance is given topically after the wound has been sutured
Paraffin gauzeOther
Also called Cuticell® Classic Paraffin Gauze
Substance is given topically after the wound has been sutured
| Study group | Role | What they receive |
|---|---|---|
| Honey | Experimental | 0.05 cc of honey (Madu Nusantara®) per 1 cm of laceration, given every predetermined wound care schedule Receives: Other: Honey |
| Povidone-iodine | Active comparator | 0.05 cc of povidone-iodine per 1 cm of laceration, given every predetermined wound care schedule Receives: Other: Povidone-iodine |
| Paraffin gauze | Active comparator | 1 layer of paraffin gauze, given every predetermined wound care schedule Receives: Other: Paraffin gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Measured by days, when was all of the sutures completely removed and the wound is completely approximated. We followed the guideline from American Academy of Family Physicians for timing for suture removal, so we will not remove the suture before the recommended time
Measured: 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 (7)
Infection
Measured using the infection signs from Delphi Criteria
Measured: 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
Pain level
measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care
Measured: 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
Itchiness
Measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care
Measured: 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
Odor
Measured using Verbal Rating Scale, consists of 4 level of odor (no odor, slight odor, medium odor, strong odor), asked from the onset of the wound and every routine wound care
Measured: 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
Exudate
Measured in grams, using digital scale with the precision of 3 digits. We measured the gauze which will be used and the one which is already on top the wound, from the onset of the wound and every routine wound care
Measured: 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
Cleanliness
Measured using images taken from the whole photographs of the wound. This parameter was measured using "less clean", "cleaner", "unchanged cleanliness". statistically using Cohen's kappa score to reach the agreement of the evaluation of this parameter
Measured: 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
Cost
Measured by counting the cost of every material used for the participant
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start29 Jan 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Laceration FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.K. Lerik General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Leonard Suryadinata, S.K. Lerik General Hospital
- Investigators
- Kevin L Suryadinata, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641053
- Sponsor's protocol ID
- SKL001
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fife CE, Carter MJ. Wound Care Outcomes and Associated Cost Among Patients Treated in US Outpatient Wound Centers: Data From the US Wound Registry. Wounds. 2012 Jan;24(1):10-7.
PubMed 25875947Sood A, Granick MS, Tomaselli NL. Wound Dressings and Comparative Effectiveness Data. Adv Wound Care (New Rochelle). 2014 Aug 1;3(8):511-529. doi: 10.1089/wound.2012.0401.
PubMed 25126472Dhivya S, Padma VV, Santhini E. Wound dressings - a review. Biomedicine (Taipei). 2015 Dec;5(4):22. doi: 10.7603/s40681-015-0022-9. Epub 2015 Nov 28.
PubMed 26615539Indonesia | Data. Indonesia [Internet]. 2017 [updated 2017; cited 2017 Jun 18]. Available from: http://data.worldbank.org/country/indonesia.
Trihono. Riset Kesehatan Dasar: Riskesdas 2013. Jakarta: Badan Penelitian dan Pengembangan Kesehatan Kementerian Kesehatan RI.
Produk Domestik Bruto - Analisis PDB Per Kapita Indonesia | Indonesia Investments. Produk Domestik Bruto Indonesia [Internet]. 2017 [updated 2017 Feb 6; cited 2017 Jun 18]. Available from: https://www.indonesia-investments.com/id/keuangan/angka-ekonomi-makro/produk-domestik-bruto-indonesia/item253.
Badan Pusat Statistik. Upah Minimum Regional/Provinsi (UMR/UMP) dan rata-rata Nasional per tahun (Dalam Rupiah), 1997-2016 [Internet]. Jakarta: Badan Pusat Statistik; 2016 [updated 2016; cited 2017 Jun 18]. Available from: https://www.bps.go.id/linkTableDinamis/view/id/917
Moeloek NF. Peraturan Menteri Kesehatan Republik Indonesia Nomor 4 Tahun 2017 Tentang Perubahan Kedua Atas Peraturan Menteri Kesehatan Nomor 52 Tahun 2016 Tentang Standar Tarif Pelayanan Kesehatan Dalam Penyelenggaraan Program Jaminan Kesehatan. Jakarta: Menteri Kesehatan Republik Indonesia; 2017. pg. 6.
Hemani ML, Lepor H. Skin preparation for the prevention of surgical site infection: which agent is best? Rev Urol. 2009 Fall;11(4):190-5.
PubMed 20111631Angel DE, Morey P, Storer JG, Mwipatayi BP. The great debate over iodine in wound care continues: a review of the literature. Wound Pract Res. 2008;16(1):6-21.
Jull AB, Walker N, Deshpande S. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD005083. doi: 10.1002/14651858.CD005083.pub3.
PubMed 23450557Saikaly SK, Khachemoune A. Honey and Wound Healing: An Update. Am J Clin Dermatol. 2017 Apr;18(2):237-251. doi: 10.1007/s40257-016-0247-8.
PubMed 28063093Nevas M, Lindstrom M, Horman A, Keto-Timonen R, Korkeala H. Contamination routes of Clostridium botulinum in the honey production environment. Environ Microbiol. 2006 Jun;8(6):1085-94. doi: 10.1111/j.1462-2920.2006.001000.x.
PubMed 16689729Shukrimi A, Sulaiman AR, Halim AY, Azril A. A comparative study between honey and povidone iodine as dressing solution for Wagner type II diabetic foot ulcers. Med J Malaysia. 2008 Mar;63(1):44-6.
PubMed 18935732Gulati S, Qureshi A, Srivastava A, Kataria K, Kumar P, Ji AB. A Prospective Randomized Study to Compare the Effectiveness of Honey Dressing vs. Povidone Iodine Dressing in Chronic Wound Healing. Indian J Surg. 2014 Jun;76(3):193-8. doi: 10.1007/s12262-012-0682-6. Epub 2012 Jul 12.
PubMed 25177115
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Honey and Povidone-iodine in Wound Healing on Acute Laceration Wounds: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT03641053
- Acronym / sponsor ID
- SKL001
- Keywords
- honey, povidone-iodine, randomized control trial, wound healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- S.K. Lerik General HospitalUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Honey | Experimental | Other: Honey0.05 cc of honey (Madu Nusantara®) per 1 cm of laceration, given every predetermined wound care schedule |
| Povidone-iodine | Active comparator | Other: Povidone-iodine0.05 cc of povidone-iodine per 1 cm of laceration, given every predetermined wound care schedule |
| Paraffin gauze | Active comparator | Other: Paraffin gauze1 layer of paraffin gauze, given every predetermined wound care schedule |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- An acute open traumatic wound
- Agrees to a voluntary agreement for informed consent
- To be treated in an outpatient setting
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoneyAlso: Madu Nusantara®Substance is given topically after the wound has been sutured | Other | Honey |
| Povidone-iodineAlso: OneMed® povidone-iodine 10%Substance is given topically after the wound has been sutured | Other | Povidone-iodine |
| Paraffin gauzeAlso: Cuticell® Classic Paraffin GauzeSubstance is given topically after the wound has been sutured | Other | Paraffin gauze |
Primary outcome
Wound healing time
Time frame: 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
Measured by days, when was all of the sutures completely removed and the wound is completely approximated. We followed the guideline from American Academy of Family Physicians for timing for suture removal, so we will not remove the suture before the recommended time
7 secondary outcomes
Infection
Time frame: 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
Pain level
Time frame: 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
Itchiness
Time frame: 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
Odor
Time frame: 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
Exudate
Time frame: 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
Cleanliness
Time frame: 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
Cost
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Background: PubMed 25875947Fife CE, Carter MJ. Wound Care Outcomes and Associated Cost Among Patients Treated in US Outpatient Wound Centers: Data From the US Wound Registry. Wounds. 2012 Jan;24(1):10-7.
- Background: PubMed 25126472Sood A, Granick MS, Tomaselli NL. Wound Dressings and Comparative Effectiveness Data. Adv Wound Care (New Rochelle). 2014 Aug 1;3(8):511-529. doi: 10.1089/wound.2012.0401.
- Background: PubMed 26615539Dhivya S, Padma VV, Santhini E. Wound dressings - a review. Biomedicine (Taipei). 2015 Dec;5(4):22. doi: 10.7603/s40681-015-0022-9. Epub 2015 Nov 28.
- BackgroundIndonesia | Data. Indonesia [Internet]. 2017 [updated 2017; cited 2017 Jun 18]. Available from: http://data.worldbank.org/country/indonesia.
- BackgroundTrihono. Riset Kesehatan Dasar: Riskesdas 2013. Jakarta: Badan Penelitian dan Pengembangan Kesehatan Kementerian Kesehatan RI.
- BackgroundProduk Domestik Bruto - Analisis PDB Per Kapita Indonesia | Indonesia Investments. Produk Domestik Bruto Indonesia [Internet]. 2017 [updated 2017 Feb 6; cited 2017 Jun 18]. Available from: https://www.indonesia-investments.com/id/keuangan/angka-ekonomi-makro/produk-domestik-bruto-indonesia/item253.
- BackgroundBadan Pusat Statistik. Upah Minimum Regional/Provinsi (UMR/UMP) dan rata-rata Nasional per tahun (Dalam Rupiah), 1997-2016 [Internet]. Jakarta: Badan Pusat Statistik; 2016 [updated 2016; cited 2017 Jun 18]. Available from: https://www.bps.go.id/linkTableDinamis/view/id/917
- BackgroundMoeloek NF. Peraturan Menteri Kesehatan Republik Indonesia Nomor 4 Tahun 2017 Tentang Perubahan Kedua Atas Peraturan Menteri Kesehatan Nomor 52 Tahun 2016 Tentang Standar Tarif Pelayanan Kesehatan Dalam Penyelenggaraan Program Jaminan Kesehatan. Jakarta: Menteri Kesehatan Republik Indonesia; 2017. pg. 6.
- Background: PubMed 20111631Hemani ML, Lepor H. Skin preparation for the prevention of surgical site infection: which agent is best? Rev Urol. 2009 Fall;11(4):190-5.
- BackgroundAngel DE, Morey P, Storer JG, Mwipatayi BP. The great debate over iodine in wound care continues: a review of the literature. Wound Pract Res. 2008;16(1):6-21.
- Background: PubMed 23450557Jull AB, Walker N, Deshpande S. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD005083. doi: 10.1002/14651858.CD005083.pub3.
- Background: PubMed 28063093Saikaly SK, Khachemoune A. Honey and Wound Healing: An Update. Am J Clin Dermatol. 2017 Apr;18(2):237-251. doi: 10.1007/s40257-016-0247-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin L Suryadinata, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Honey, Povidone-iodine and Paraffin gauze in people with Laceration Face and Wound Heal, run by S.K. Lerik General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641053, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.