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Honey Versus Povidone-iodine on Laceration Wounds

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ClinicalTrials.gov Identifier: NCT03641053
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Leonard Suryadinata, S.K. Lerik General Hospital

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.


Condition or disease Intervention/treatment Phase
Laceration Face Wound Heal Wounds and Injuries Laceration Arm Laceration of Leg Other: Honey Other: Povidone-iodine Other: Paraffin gauze Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Masking Description: Participants do not know which intervention substance they have been assigned to
Primary Purpose: Treatment
Official Title: Comparison of Honey and Povidone-iodine in Wound Healing on Acute Laceration Wounds: A Randomized Controlled Trial Study
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Honey
0.05 cc of honey (Madu Nusantara®) per 1 cm of laceration, given every predetermined wound care schedule
Other: Honey
Substance is given topically after the wound has been sutured
Other Name: Madu Nusantara®

Active Comparator: Povidone-iodine
0.05 cc of povidone-iodine per 1 cm of laceration, given every predetermined wound care schedule
Other: Povidone-iodine
Substance is given topically after the wound has been sutured
Other Name: OneMed® povidone-iodine 10%

Active Comparator: Paraffin gauze
1 layer of paraffin gauze, given every predetermined wound care schedule
Other: Paraffin gauze
Substance is given topically after the wound has been sutured
Other Name: Cuticell® Classic Paraffin Gauze




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Measured using the infection signs from Delphi Criteria

  2. 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 ]
    measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care

  3. 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 ]
    Measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care

  4. 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 ]
    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

  5. 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 ]
    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

  6. 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 ]
    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

  7. 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 ]
    Measured by counting the cost of every material used for the participant



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641053


Locations
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Indonesia
S.K. Lerik General Hospital
Kupang, East Nusa Tenggara, Indonesia, 85227
Sponsors and Collaborators
S.K. Lerik General Hospital
Investigators
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Principal Investigator: Kevin L Suryadinata, MD
  Study Documents (Full-Text)

Documents provided by Kevin Leonard Suryadinata, S.K. Lerik General Hospital:
Informed Consent Form  [PDF] September 4, 2017


Publications:
Indonesia | 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.
Angel 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.
Thorne CHM, Gurtner GC, Chung K, Gosain A Mehrara B, Rubin P, Spear SL Grabb and Smith's Plastic Surgery. 7th ed.. Lippincott Williams & Wilkins, Philadelphia, USA. Pg. 14-17.
Kumar V, Cotran RS, Robbin ST. Robbins basic Pathology. 7th ed. Philadelphia, 2003, Saunders.
Troxler M, Vowden K, Vowden P. 2006. Integrating Adjunctive Therapy into Practice: The Importance of Recofnising 'Hard-to-Heal' Wounds.
Fonseca JA et al. Medscape Education. Burn Wound Infections. [Online]. Updated May 25, 2016. Available at http://emedicine.medscape.com/article/213595-overview. Accessed June 16, 2017.
Portenoy RK, Tanner RM. Pain Management: Theory and Practice. Oxford: Oxford University Press; 1996.

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Responsible Party: Kevin Leonard Suryadinata, Kevin Leonard Suryadinata, MD. Principal Investigator and General Practitioner of S.K. Lerik General Hospital, S.K. Lerik General Hospital
ClinicalTrials.gov Identifier: NCT03641053     History of Changes
Other Study ID Numbers: SKL001
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevin Leonard Suryadinata, S.K. Lerik General Hospital:
honey
povidone-iodine
randomized control trial
wound healing

Additional relevant MeSH terms:
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Wounds and Injuries
Lacerations
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes