Compare Effects of Dressing With Honey and EUSOL

NCT ID: NCT04831112

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-12-31

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.

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.

Conditions

Necrotizing Fascitis; Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Honey

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

Group Type: EXPERIMENTAL

Honey

Intervention Type: DRUG

Dressing of necrotizing fascitis wounds with honey.

EUSOL

Intervention Type: COMBINATION_PRODUCT

Dressing of necrotizing fascitis wounds with EUSOL.

EUSOL

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

Group Type: ACTIVE_COMPARATOR

Honey

Intervention Type: DRUG

Dressing of necrotizing fascitis wounds with honey.

EUSOL

Intervention Type: COMBINATION_PRODUCT

Dressing of necrotizing fascitis wounds with EUSOL.

Interventions

Honey

Dressing of necrotizing fascitis wounds with honey.

Intervention Type: DRUG

EUSOL

Dressing of necrotizing fascitis wounds with EUSOL.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Diabetic Foot wounds
• Traumatic wounds

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Lajpat Rai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr Ruth K.M Pfau Civil Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

IRB-1491/DUHS/Approval/2020

Identifier Type: -

Identifier Source: org_study_id