The Efficacy of Chlorhexidine Gluconate Gel Dressing in Preventing Surgical Drain Site Infection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Erythema Measurement
研究概览
简要总结
This study aims to evaluate if the application of chlorhexidine gluconate dressing on surgical drain sites can decrease drain site infection vs the standard of care (dry, sterile gauze).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Receiving two surgical drains during one of the following types of operative procedures: breast reduction, breast augmentation, abdominoplasty, panniculectomy, brachioplasty, thigh lift, lower body lift, belt lipectomy, back latissimus dorsi reconstruction, bilateral breast reconstruction, or bilateral chest reconstruction. These drains may be in fairly close proximity to one another but they must emerge from different areas of the skin, that way they can be considered to be located in two different sites.
排除标准
- •Concurrent implantation of any foreign objects, such as a breast implant
- •Patients who receive postoperative antibiotics without a suspected or identified site of infection
- •Subjects allergic to or hypersensitive to chlorhexidine gluconate. Before enrolling in the study, patients will be asked about previous exposure to chlorhexidine products and about their allergies. Those with potential allergic or adverse reaction to chlorhexidine will be excluded from the study.
结局指标
主要结局
Change in Erythema Measurement
时间窗: Day 0, up to Month 6
Drain site erythema will be measured with a ruler, in millimeters.
Number of participants in each category of skin induration (flat, soft, or firm)
时间窗: up to Month 6
2. Induration of skin will be measured by palpation of the skin around the drain by the clinician. This will be measured by assessing whether skin is flat, soft, or firm.
Total amount of drainage from drain site
时间窗: Up to Month 6
Amount of drainage from drain site will be measured in cubic centimeters.
Number of participants who experience pain post-op
时间窗: Up to Month 6
5. Pain will be measured by asking patients if they experience pain (yes or no) when the clinician presses on the drain site.
Number of participants in each category of quality of drainage (serous, sanguineous, or purulent)
时间窗: Day 0, up to Month 6
Quality of drainage will be assessed by measuring thickness of drainage. Thickness of drainage will be measured as serous, sanguineous, or purulent.
Change in distance between skin changes and normal looking skin
时间窗: Day 0, up to Month 6
Extent of skin changes is measured using a ruler, in millimeters, to calculate the distance between skin changes and normal looking skin.
次要结局
- Number of participants displaying presence of hematoma(up to Month 6)
- Number of participants displaying sterility of seroma(up to Month 6)
- Number of participants displaying signs of wound infection(up to Month 6)
- Antibiotic prescription rate(up to Month 6)