Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting
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
- 是
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
Faraz Adil
Principal Investigator
Dow University of Health Sciences
