Honey Versus Povidone-iodine on Laceration Wounds
Primary Purpose
Laceration Face, Wound Heal, Wounds and Injuries
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Honey
Povidone-iodine
Paraffin gauze
Sponsored by
About this trial
This is an interventional treatment trial for Laceration Face focused on measuring honey, povidone-iodine, randomized control trial, wound healing
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
Sites / Locations
- S.K. Lerik General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Honey
Povidone-iodine
Paraffin gauze
Arm Description
0.05 cc of honey (Madu Nusantara®) per 1 cm of laceration, given every predetermined wound care schedule
0.05 cc of povidone-iodine per 1 cm of laceration, given every predetermined wound care schedule
1 layer of paraffin gauze, given every predetermined wound care schedule
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Infection
Measured using the infection signs from Delphi Criteria
Pain level
measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care
Itchiness
Measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care
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
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
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
Cost
Measured by counting the cost of every material used for the participant
Full Information
NCT ID
NCT03641053
First Posted
August 16, 2018
Last Updated
August 27, 2018
Sponsor
S.K. Lerik General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03641053
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 29, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
S.K. Lerik General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration Face, Wound Heal, Wounds and Injuries, Laceration Arm, Laceration of Leg
Keywords
honey, povidone-iodine, randomized control trial, wound healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Participants do not know which intervention substance they have been assigned to
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Honey
Arm Type
Experimental
Arm Description
0.05 cc of honey (Madu Nusantara®) per 1 cm of laceration, given every predetermined wound care schedule
Arm Title
Povidone-iodine
Arm Type
Active Comparator
Arm Description
0.05 cc of povidone-iodine per 1 cm of laceration, given every predetermined wound care schedule
Arm Title
Paraffin gauze
Arm Type
Active Comparator
Arm Description
1 layer of paraffin gauze, given every predetermined wound care schedule
Intervention Type
Other
Intervention Name(s)
Honey
Other Intervention Name(s)
Madu Nusantara®
Intervention Description
Substance is given topically after the wound has been sutured
Intervention Type
Other
Intervention Name(s)
Povidone-iodine
Other Intervention Name(s)
OneMed® povidone-iodine 10%
Intervention Description
Substance is given topically after the wound has been sutured
Intervention Type
Other
Intervention Name(s)
Paraffin gauze
Other Intervention Name(s)
Cuticell® Classic Paraffin Gauze
Intervention Description
Substance is given topically after the wound has been sutured
Primary Outcome Measure Information:
Title
Wound healing time
Description
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
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
Secondary Outcome Measure Information:
Title
Infection
Description
Measured using the infection signs from Delphi Criteria
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
Title
Pain level
Description
measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care
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
Title
Itchiness
Description
Measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care
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
Title
Odor
Description
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
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
Title
Exudate
Description
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
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
Title
Cleanliness
Description
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
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
Title
Cost
Description
Measured by counting the cost of every material used for the participant
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin L Suryadinata, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.K. Lerik General Hospital
City
Kupang
State/Province
East Nusa Tenggara
ZIP/Postal Code
85227
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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Honey Versus Povidone-iodine on Laceration Wounds
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