Compare Effects of Dressing With Honey and EUSOL

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831112
• Other study ID #: IRB-1491/DUHS/Approval/2020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age >18 years and <70 years.

• Necrotizing fasciitis wounds

• Wide span of wound <20cm

Exclusion Criteria:

• Diabetic Foot wounds

• Traumatic wounds

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Necrotizing Fascitis
• Wound Infection

Intervention

Drug:
• Honey
Dressing of necrotizing fascitis wounds with honey.

Combination Product:
• EUSOL
Dressing of necrotizing fascitis wounds with EUSOL.

Locations

Country	Name	City	State
Pakistan	Dr Ruth K.M Pfau Civil Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early wound healing	Early wound healing is measured via appearance of granulation tissue over the wound.	3 weeks
Secondary	Decreased hospital stay	Decrease of hospital stay is determined via early discharge of patient from hospital and managed as out patient.	4 weeks