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临床试验/NCT04613336
NCT04613336Unknown不适用

Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
decrease in size of wound and decrease in surrounding skin edema

研究概览

简要总结

Wound is defined by the breach in dermis of the skin. It can be caused by road traffic accidents, tumor excision, chronic illness like diabetes, bed sores in bedridden patients, burns, insects' bites etc. Treatment goals for wound coverage includes earliest debridement, dressings, local antibiotics, limb elevation, fracture fixations and wound coverage. Skin graft functions both as occlusive dressing, as a skin replacement and as a stimulus for healing. Even though the usage of flaps to cover the wounds has been increased recently still skin grafting serves as an easiest and simplest way of covering the wound. However, skin grafting introduces another wound in addition to the existing wound, the donor site wound (DSW). A secondary donor-site wound (DSW) is formed after harvesting split thickness skin graft which adds up with the primary wound to increase the total size of the wounds for the healing process. This donor site wound cause itching, pain and cosmetic embarrassment. That is why the proper and timely healing of the donor site wound is of great importance. Basic management of DSWs includes conventional dressings that provides absorption of bleeding solely.

详细描述

This is a randomized control trial that will be conducted at Dr. Ruth K.M. Pfau, Civil Hospital Karachi for a duration of six months after approval of the synopsis. Randomization will be done using sequentially numbered, opaque, sealed envelopes (SNOSE). A sample size of total 60 patients was calculated through OpenEpi. Patients will be counseled about the procedure of grafting and change of dressings postoperatively. Inclusion Criteria: age between 18 to 55 years, both genders, non-hypertensive patients, hemoglobin levels more than 10 g/dl, Platelet count above 150 to 400 × 109/L, wounds for more than 6 weeks. Exclusion Criteria: Hypertensive patients, bleeding tendencies (Disorder), immune-compromised, familial history of bleeding. The trial will be registered with clinical trial unit (CTU) of the Dow University of Health Sciences. Statistical analyses will be done using SPSS version 21. Descriptive analyses will be reported for all variables including age, gender, treatment group distribution and other independent and dependent variables. Inferential statistics will be reported using comparison of treatment groups using repeated measure ANOVA. P-value of <0.05 will be considered as significant. The expected total expenditure on the research project will be twenty thousand.

Data will be collected with change of dressings at graft donor site wound (DSW) that is the thigh. Study objectives will be discussed and explained to the patients before surgery as part of their change of dressings post operatively as in routine. Potential benefits and discomforts of the procedure will be explained. There is no potential adverse effects of heparin on wound or patients. Participants will receive both oral and written information about the study. Consent form will be filled by the participants. Questionnaire with photographic assessment will be filled at every change of dressing.

Split-thickness skin graft will be harvested from medial side of thigh in two strips of about 10*6cm with a few cm break in between them, with a Humby knife adjusted on with a randomized setting to harvest a fixed depth of skin graft. After harvesting the graft the donor site wound will be photographed, cleaned with saline and dressed with impregnated wax gauzes and sterilized cotton covered in roll gauze.

At first postoperative day, donor site cotton dressing will be opened. Heparin and conventional dressing group allocation will be done through randomization in order to prevent any confounding factors such as baseline differences in depth of wound. Patients will be provided with paper chits to choose from, with A or B marked on it. The proximal strip of donor site wound (DSW) will be dressed according to the chit chosen. Patients picking up A chit will be dealt as 'control half (conventional dressing)', where by patients picking up B chit will be dealt as 'intervention half'.

The 'control half' will be redressed with sterilized cotton covered in roll gauze whereas 'intervention half' of wound will be sprayed with 5000 I.U/ml concentration of the heparin placed in a 5 cc syringe. Then the wound will be redressed with sterilized cotton covered in roll gauze. This will be repeated on donor site 'intervention half' of wound on daily basis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • • age between 18 to 55 years
  • both genders
  • non hypertensive patients
  • Hemoglobin levels more than 10 g/dl
  • Platelet count above 150 to 400 × 109/L
  • Wounds for more than 6 weeks
  • Any size of wound greater then 10*10 cm

排除标准

  • • Hypertensive patients,
  • Bleeding tendencies (Disorder),
  • Immune-compromised,
  • Familial history of bleeding

结局指标

主要结局

decrease in size of wound and decrease in surrounding skin edema

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Faraz Adil

Principal Investigator

Dow University of Health Sciences

研究点 (1)

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