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CompletedNCT04831112Updated Nov 15, 2022

Compare Effects of Dressing With Honey and EUSOL

An interventional study of Honey and EUSOL in Necrotizing Fascitis and Wound Infection, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Honey is super saturated solution containing sugar derived from nectar gathered by honeybee. Honey is viscus supersaturated solution mainly composed of sugar and water along with minor constituents such as minerals, vitamins, amino acids, organic acids, flavonoids, and other phenolic compound and aromatic substances. Honey contents according to percentages are fructose 38.6%, glucose 31%, water 17%, lactose 7.2%, larger sugars 4.7% and rest of micronutrients and elemental compounds are 1.5%. Honey enhances wound healing by removing slough and necrotic tissue from wound. It promotes wound healing by increasing angiogenesis, granulation and epithelization. Honey possess antimicrobial activity against bacteria like methicillin resistant staphylococcus aureus, vancomycin resistant Escherichia Coli, pseudomonas aeruginosa, and many other species. It also has activity against some yeast species such as aspergillus and penicillium.

Honey used for dressing will be 'Langnese Honey". Langnese honey is raw honey / unprocessed packed as collected, quality and quantity will be same for patients.

Read the detailed description

This prospective randomized trial will be conducted in all patients undergoing dressing after debridement of necrotizing fasciitis wounds. Study will be conducted for 6 months after approval IRB. Patient will be inducted through emergency department. After debridement, patient will be enrolled in study via simple random sampling for dressing with either EUSOL or Honey. Honey quantity for wound will be 4ml per square inch. In patient whose both limbs involved by necrotizing fasciitis, after debridement, dressing will be done with honey in one limb and EUSOL in other limb. Patient will be enrolled in study whose debridement already done.

EUSOL is solution commonly used for dressing of wounds. Honey is also used for dressing of wounds. Honey is a viscous, supersaturated sugar derived from nectar gathered by a honeybee. Honey enhances wound healing by providing moist environment, antibacterial activity, deodorizes, decrease inflammation, edema and exudation. Honey increase rate of wound healing by promoting angiogenesis, granulation and epithelization. Dressing will be done by residents of our ward under supervision of faculty. At first time of debridement pus or tissue will be sent for culture and sensitivity meanwhile broad-spectrum antibiotic will be started. Once dressing will started, wide wound span will be measured and assessed daily for granulation tissue and removal of slough. Questionnaire will be filled by PI for allergic reaction to solution, appearance of granulation tissue and hospital stay.

02

Conditions studied

  • Necrotizing Fascitis
  • Wound Infection
03

In context

Fasciitis, Necrotizing

28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.

This study's enrollment of 326 is above the median of 74 across 12 interventional studies indexed under Fasciitis, Necrotizing.

Browse Fasciitis, Necrotizing studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >18 years and \<70 years.
  • Necrotizing fasciitis wounds
  • Wide span of wound \<20cm

Exclusion criteria

Exclusion Criteria:

  • Diabetic Foot wounds
  • Traumatic wounds
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
326 participants (actual)

Study arms

  • Experimental
    Honey

    Topical honey to be used for dressing 4ml per square inch.

    Drug: Honey · Combination Product: EUSOL

  • Active comparator
    EUSOL

    EUSOL soaked gauze to be placed over the wound as dressing.

    Drug: Honey · Combination Product: EUSOL

Interventions

  • DrugHoney

    Dressing of necrotizing fascitis wounds with honey.

  • Combination productEUSOL

    Dressing of necrotizing fascitis wounds with EUSOL.

06

What researchers measure

Primary outcomes

  1. Early wound healing

    Early wound healing is measured via appearance of granulation tissue over the wound.

    Time frame: 3 weeks

Secondary outcomes

  1. Decreased hospital stay

    Decrease of hospital stay is determined via early discharge of patient from hospital and managed as out patient.

    Time frame: 4 weeks

07

Study locations

1 site
  • Dr Ruth K.M Pfau Civil Hospital
    Karachi, Sindh 75000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2020 to primary completion in Dec 2021, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2021
First posted
Apr 5, 2021
StartActual
Mar 1, 2020
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
Nov 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04831112
Responsible party
Lajpat Rai (Principal Investigator, Dow University of Health Sciences) — Principal investigator
First posted
Apr 5, 2021
Start date
Mar 1, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Nov 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Honey

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