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
NCT number | NCT02400372 |
Other study ID # | 0079-14 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | January 2020 |
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.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Patients with a wound on the hip - the implant donor area - Wound size up to 100 smĀ² Exclusion Criteria: - Known sensitivity of the patient to honey - Pregnant women - Patients under 18 years |
Country | Name | City | State |
---|---|---|---|
Israel | HaEmekMC | `Afula |
Lead Sponsor | Collaborator |
---|---|
HaEmek Medical Center, Israel |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 25 days | |
Secondary | To Evaluatee the effect of Medihoney antibacterial wound dressing on pain intensity donor site. | The Outcome will be assessed by Medical examination and Questionnaire | 25 days | |
Secondary | 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 | 25 days | |
Secondary | 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 | 25 days |
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