NCT02400372

Brief Summary

The study, "Evaluation of the effect of antibacterial medical honey dressing for healing of implants donor area", is a Phase 4 Study, Prospective, A randomized trial, 3 arms (treatment groups) trial, Open-label, non-controlled, non-randomized, Aims To test the effectiveness of antibacterial medical honey dressing in the therapy of donor area of implants. In our Research Will participate in 135 new patients over the age of 18, with a wound in the donor area of hip implants, Hospitalized in the Plastic Surgery Unit of the "Haemek" Medical Center. Appropriate patients, who will agree to sign and sign a consent form, be assigned randomly to one of three treatment groups:

  1. 1.The research group: Medihoney antibacterial wound dressing.
  2. 2.The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature.
  3. 3.Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

4.7 years

First QC Date

February 10, 2015

Last Update Submit

August 14, 2019

Conditions

Disorder of Skin Donor Site

Outcome Measures

Primary Outcomes (1)

  • Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure

    The Outcome will be assessed by Medical examination and Laboratory Testing

    25 days

Secondary Outcomes (4)

  • To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.

    25 days

  • To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.

    25 days

  • To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.

    25 days

  • To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.

    25 days

Study Arms (3)

research group

EXPERIMENTAL

Medihoney Dressing

Device: medihoney dressing

control group

NO INTERVENTION

Paraffin gauze with saline Dressing

3. Comparison group

NO INTERVENTION

Polymem dressing

Interventions

medihoney dressingDEVICE

to evaluate the effect of medihoney dressing on the healing of split thickness skin graft donor site

research group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a wound on the hip - the implant donor area
  • Wound size up to 100 sm²

You may not qualify if:

  • Known sensitivity of the patient to honey
  • Pregnant women
  • Patients under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmekMC

Afula, 18341111, Israel

RECRUITING

Study Officials

  • Aziz Shufani, MD

    HaEmek Medical Center, Afula

    PRINCIPAL INVESTIGATOR

Central Study Contacts

gilat Ron avraham

CONTACT

972-52-8495336gilat_av@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

March 27, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

IL(1)