Disorder of Skin Donor Site Clinical Trial
Official title:
The Effect of Anti-bacterial Honey Dressing on the Healing of Split Thickness Skin Graft Donor Site
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. The research group: Medihoney antibacterial wound dressing.
2. The control group: Paraffin gauze with saline- The basic treatment in the donor site,
accepted the literature.
3. 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.
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:
1. The research group: Medihoney antibacterial wound dressing.
2. The control group: Paraffin gauze with saline- The basic treatment in the donor site,
accepted the literature.
3. 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
1. To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity
donor site.
2. . To Evaluatee the effect of Medihoney antibacterial wound dressing on the frequency of
infections in donor site.
Tertiary goal
1. To evaluate the effect of Medihoney antibacterial wound dressing on the unpleasant odor
in the donor site.
2. 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.
;
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