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临床试验/NCT02400372
NCT02400372Unknown4 期

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

HaEmek Medical Center, Israel2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
135
试验地点
2
主要终点
Examining the effect of Medihoney antibacterial wound dressing honey on the duration of the donor site area healing, until full recovery and wound closure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

research group

Experimental

Medihoney Dressing

干预措施: medihoney dressing (Device)

control group

No Intervention

Paraffin gauze with saline Dressing

3. Comparison group

No Intervention

Polymem dressing

结局指标

主要结局

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

时间窗: 25 days

The Outcome will be assessed by Medical examination and Laboratory Testing

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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