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Compare Effects of Dressing With Honey and EUSOL

Primary Purpose

Necrotizing Fascitis, Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Honey
EUSOL
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Fascitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic Foot wounds
  • Traumatic wounds

Sites / Locations

  • Dr Ruth K.M Pfau Civil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Honey

EUSOL

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2021
Last Updated
November 13, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04831112
Brief Title
Compare Effects of Dressing With Honey and EUSOL
Official Title
A Comparative Study Between the Use of Topical Honey and EUSOL Dressing in Necrotizing Fascitis Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Fascitis, Wound Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental randomised trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Honey
Arm Type
Experimental
Arm Description
Topical honey to be used for dressing 4ml per square inch.
Arm Title
EUSOL
Arm Type
Active Comparator
Arm Description
EUSOL soaked gauze to be placed over the wound as dressing.
Intervention Type
Drug
Intervention Name(s)
Honey
Intervention Description
Dressing of necrotizing fascitis wounds with honey.
Intervention Type
Combination Product
Intervention Name(s)
EUSOL
Intervention Description
Dressing of necrotizing fascitis wounds with EUSOL.
Primary Outcome Measure Information:
Title
Early wound healing
Description
Early wound healing is measured via appearance of granulation tissue over the wound.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Decreased hospital stay
Description
Decrease of hospital stay is determined via early discharge of patient from hospital and managed as out patient.
Time Frame
4 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Dr Ruth K.M Pfau Civil Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Compare Effects of Dressing With Honey and EUSOL

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