Honey Versus Povidone-iodine on Laceration Wounds

NCT03641053 | Completed Phase 3 DMC

• 1 other identifier: SKL001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Laceration Face; Wound Heal; Wounds and Injuries; Laceration Arm; Laceration of Leg

Keywords

honey; povidone-iodine; randomized control trial; wound healing

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  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

Study Arms (3)

Honey

EXPERIMENTAL

0.05 cc of honey (Madu Nusantara®) per 1 cm of laceration, given every predetermined wound care schedule

Other: Honey

Povidone-iodine

ACTIVE COMPARATOR

0.05 cc of povidone-iodine per 1 cm of laceration, given every predetermined wound care schedule

Other: Povidone-iodine

Paraffin gauze

ACTIVE COMPARATOR

1 layer of paraffin gauze, given every predetermined wound care schedule

Other: Paraffin gauze

Interventions

Honey OTHER

Substance is given topically after the wound has been sutured

Also known as: Madu Nusantara®

Honey

Povidone-iodine OTHER

Substance is given topically after the wound has been sutured

Also known as: OneMed® povidone-iodine 10%

Povidone-iodine

Paraffin gauze OTHER

Substance is given topically after the wound has been sutured

Also known as: Cuticell® Classic Paraffin Gauze

Paraffin gauze

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• S.K. Lerik General Hospital: lead

Study Sites (1)

S.K. Lerik General Hospital

Kupang, East Nusa Tenggara, 85227, Indonesia

Location

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MeSH Terms

Conditions

Wounds and Injuries

Interventions

Honey; Povidone-Iodine

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kevin L Suryadinata, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know which intervention substance they have been assigned to
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kevin Leonard Suryadinata, MD. Principal Investigator and General Practitioner of S.K. Lerik General Hospital

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: January 29, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)