Compare Effects of Dressing With Honey and EUSOL

NCT04831112 | Completed

• 1 other identifier: IRB-1491/DUHS/Approval/2020
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Necrotizing Fascitis; Wound Infection

Outcome Measures

Primary Outcomes (1)

• Early wound healing

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

  3 weeks

Secondary Outcomes (1)

• Decreased hospital stay

  4 weeks

Study Arms (2)

Honey

EXPERIMENTAL

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

Drug: Honey; Combination Product: EUSOL

EUSOL

ACTIVE COMPARATOR

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

Drug: Honey; Combination Product: EUSOL

Interventions

Honey DRUG

Dressing of necrotizing fascitis wounds with honey.

EUSOL; Honey

EUSOL COMBINATION_PRODUCT

Dressing of necrotizing fascitis wounds with EUSOL.

EUSOL; Honey

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Diabetic Foot wounds
• Traumatic wounds

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr Ruth K.M Pfau Civil Hospital

Karachi, Sindh, 75000, Pakistan

Location

MeSH Terms

Conditions

Fasciitis, Necrotizing; Wound Infection

Interventions

Honey; Eusol

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Infections

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental randomised trial

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 5, 2021
• Study Start: March 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)