Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burn Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- mean time for skin grafting
研究概览
简要总结
There is a difference in frequency of wound infection, mean pain score, mean of time for skin grafting and hospital stay in pediatric 2nd and 3rd degree burns, between amniotic membrane and duoderm dressings
详细描述
After informed consent of the patients, patients who will fulfill the inclusion and exclusion criteria will be enrolled in the study from Department of Pediatric Surgery, Mayo Hospital Lahore and will be randomly allocated by lottery method into 2 groups by the doctor. Group A and B with 86 patients in each group. Group A patients will be undergoing amniotic membrane dressing, while group B patients will undergo colloid gel foam dressing. Basic demographic information will be noted. Effect modifiers (hemoglobin level, weight and height) will be noted.
In group A, the wounds will be washed with normal saline and then covered with amniotic membrane over which a layer of Vaseline gauze will be applied and dressing with gauze and the crape bandage will be applied. Every 3-4 days these dressings will be changed and assessed for pain, wound infection and wound c/s will be sent. Placentas from clean vaginal deliveries and elective C-sections will be taken. Blood of mother will be screened. Amniotic membrane will be separated from placenta in a clean sterile bowl. Bowl will be put in refrigerator at 4 degrees.
In group B, wound will be washed with normal saline . The wound site will be covered with Colloid Gel Foam and gauze, and crape bandage will be applied. Dressing will be changed after 3-4 days. The outcome (pain score, wound infection,time for skin grafting and hospital stay) will be compared in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10-45 % percent 2nd and 3rd degree fresh burns age less than 12 years patients of both gender
排除标准
- •patients whose parents are not willing patients whose wound c/s comes positive at the time of admission patients who have associated medical disorder and trauma.
结局指标
主要结局
mean time for skin grafting
时间窗: average time will be 21 days
time for grafting when wound has healthy granulation tissue
frequency of wound infection
时间窗: at 5th day of dressing
redness around burnt wound, tenderness, swelling, increased temperature (\>4 degrees), exudation and growth on wound cultures
mean of pain for patients of age <8 years assessed by Visual Analogue Score
时间窗: at 5th day of dressing change
pain will be assessed at the time of dressing change. for patients\<8 years of age visual analogue score will be used.
mean of hospital stay
时间窗: at the time of discharge, that can be from 7th day to 30th day
time at which patient wound is completely healed and no wound infection present, average time will be up to 30 days
mean of pain for patients of age >8 years assessed by Face, Leg, Activity, Cry, Consolabilty Pain Scale.
时间窗: at 5th day of dressing change
FLACC (face,leg, activity, cry, consolability) pain scale will be used
次要结局
未报告次要终点
研究者
Fatima Numeri
Assistant Professor
King Edward Medical University