search
Back to results

The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site

Primary Purpose

Disorder of Skin Donor Site

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
medihoney dressing
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Skin Donor Site

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • HaEmekMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

research group

control group

3. Comparison group

Arm Description

Medihoney Dressing

Paraffin gauze with saline Dressing

Polymem dressing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.
The Outcome will be assessed by Medical examination and Laboratory Testing
To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.
The Outcome will be assessed by Medical examination and Questionnaire
To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.
The Outcome will be assessed by Medical examination and Questionnaire
To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.
The Outcome will be assessed by Medical examination and Questionnaire

Full Information

First Posted
February 10, 2015
Last Updated
August 14, 2019
Sponsor
HaEmek Medical Center, Israel
search

1. Study Identification

Unique Protocol Identification Number
NCT02400372
Brief Title
The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site
Official Title
The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: The research group: Medihoney antibacterial wound dressing. The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature. Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center. Participants in the three study groups will be performed, each visit, Medical monitoring and examination by a team of medical indices of Plastic Surgery Unit, as is customary. The treatment will be performed, twice a week until recovery and the complete closure of the wound.
Detailed Description
Study protocol The aim of this study is to evaluate "The effect of anti-bacterial honey dressing on the healing of split thickness skin graft donor site". Protocol Abstract. The use of skin grafts for wound closure is considered one of the common methods in the field of plastic surgery. Healing of the donor area is secondary, gradual and is a serious problem, Associated with a high percentage of wound infections, Delay in healing, Scars, Pain unpleasant odor and other problems. As of today, there is no ideal treatment to cure the donor area of implants, due to lack of high-quality comparative studies. The use of honey to treat wounds known for centuries in different cultures. Honey has anti-inflammatory and anti-bacterial effect, Debridement ability, and Pain relief. Honey has almost no side effects. Effectiveness of honey in wound healing has been tested in many clinical trials, but most of them and some methodological problems of low quality. Therefore, it is difficult to conclude that the existing information handling guidelines and recommending further clinical research. 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: The research group: Medihoney antibacterial wound dressing. The control group: Paraffin gauze with saline- The basic treatment in the donor site, accepted the literature. Comparison group: Polymem dressing - Common treatment in the donor site in the Plastic Surgery Unit of the "Haemek" Medical Center. Participants in the three study groups will be performed, each visit, Medical monitoring and examination by a team of medical indices of Plastic Surgery Unit, as is customary. The treatment will be performed, twice a week until recovery and the complete closure of the wound. Research Goals Primary goal Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure. Secondary objectives To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site. . To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site. Tertiary goal To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site. 2. To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site. Research Hypothesis Medihoney antibacterial wound dressing will find significantly statistical more effective in comparison with Paraffin gauze with saline dressing and compared with Polymem dressing, In terms of duration of a treatment, Intensity of pain and the prevalence of infection in the donor site. Treatment regimen First group Immediately after harvesting the skin, the donor site will be covered with a thin layer of Medihoney Antibacterial Wound Gel and Xtrasorb Super Absorbent Dressing will used as secondary dressing. After 24 hours, the dressing will be replaced by Medihoney HCS dressing. Medihoney HCS dressing will be replace twice a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Skin Donor Site

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
research group
Arm Type
Experimental
Arm Description
Medihoney Dressing
Arm Title
control group
Arm Type
No Intervention
Arm Description
Paraffin gauze with saline Dressing
Arm Title
3. Comparison group
Arm Type
No Intervention
Arm Description
Polymem dressing
Intervention Type
Device
Intervention Name(s)
medihoney dressing
Intervention Description
to evaluate the effect of medihoney dressing on the healing of split thickness skin graft donor site
Primary Outcome Measure Information:
Title
Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure
Description
The Outcome will be assessed by Medical examination and Laboratory Testing
Time Frame
25 days
Secondary Outcome Measure Information:
Title
To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of infections in donor site.
Description
The Outcome will be assessed by Medical examination and Laboratory Testing
Time Frame
25 days
Title
To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site.
Description
The Outcome will be assessed by Medical examination and Questionnaire
Time Frame
25 days
Title
To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor in the donor site.
Description
The Outcome will be assessed by Medical examination and Questionnaire
Time Frame
25 days
Title
To evaluate the effect of Medihoney antibacterial wound dressing on patient satisfaction from treatment in donor site.
Description
The Outcome will be assessed by Medical examination and Questionnaire
Time Frame
25 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a wound on the hip - the implant donor area Wound size up to 100 sm² Exclusion Criteria: Known sensitivity of the patient to honey Pregnant women Patients under 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gilat Ron avraham
Phone
972-52-8495336
Email
gilat_av@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aziz Shufani, MD
Organizational Affiliation
HaEmek Medical Center, Afula
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmekMC
City
'Afula
ZIP/Postal Code
18341111
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site

We'll reach out to this number within 24 hrs