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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03641053
Other study ID # SKL001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 29, 2018
Est. completion date June 30, 2018

Study information

Verified date August 2018
Source S.K. Lerik General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 60 Years
Eligibility 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

Study Design


Intervention

Other:
Honey
Substance is given topically after the wound has been sutured
Povidone-iodine
Substance is given topically after the wound has been sutured
Paraffin gauze
Substance is given topically after the wound has been sutured

Locations

Country Name City State
Indonesia S.K. Lerik General Hospital Kupang East Nusa Tenggara

Sponsors (1)

Lead Sponsor Collaborator
S.K. Lerik General Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (32)

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Gulati 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. — View Citation

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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. Review. Update in: Cochrane Database Syst Rev. 2015;(3):CD005083. — View Citation

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Saikaly 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. Review. — View Citation

Shukrimi 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. — View Citation

Siddiqui AR, Bernstein JM. Chronic wound infection: facts and controversies. Clin Dermatol. 2010 Sep-Oct;28(5):519-26. doi: 10.1016/j.clindermatol.2010.03.009. Review. — View Citation

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* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Infection Measured using the infection signs from Delphi Criteria 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 Pain level measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care 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 Itchiness Measured using Numeral Rating Scale from 0-10, asked from the onset of the wound and every routine wound care 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 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 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 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 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 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 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 Cost Measured by counting the cost of every material used for the participant 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
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