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Completed

NCT Number: NCT04831112

Compare Effects of Dressing With Honey and EUSOL

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.

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Key information

Conditions

Necrotizing Fascitis Fasciitis Fasciitis, Necrotizing Infections Musculoskeletal Diseases Wound Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Ruth K.M Pfau Civil Hospital

Karachi, Sindh, 75000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Diabetic Foot wounds
  • Traumatic wounds

Treatment and study plan

Honey

Drug

Dressing of necrotizing fascitis wounds with honey.

EUSOL

Combination Product

Dressing of necrotizing fascitis wounds with EUSOL.

Primary outcomes

  1. Early wound healing

    Time frame: 3 weeks

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

Secondary outcomes

  1. Decreased hospital stay

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

A Comparative Study Between the Use of Topical Honey and EUSOL Dressing in Necrotizing Fascitis Wounds

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 5, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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