Evaluation of the role of nanocrystalline silver dressing in healing of soft tissue injuries involving the maxillofacial region- A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Healing (assessment of scar formation)
研究概览
简要总结
Soft tissue injuries of the face constitute one of the most commonly encountered problems by maxillofacial surgeons. These injuries present in the form of abrasion, laceration or avulsion which may lead to severe cosmetic and /or functional problems; cosmetic problems include scars, uneven skin surface/dehiscence and hyper or hypo pigmentation while functional problems include restricted facial movements, infection, hemorrhage and nerve damage. The conventional methods of treating these injuries include betadine dressing, chlorhexidine dressing, Framycetin sulfate dressing, tissue adhesives, collagen dressing, foam dressing, hydrocolloid dressing, suturing and the use of split/full skin graft. However, these are associated with limitations in terms of usage, clinical outcome, allergic reactions, patient compliance and expense. The advantages of nanocrystalline silver dressing are many; sustained release of non-ionic form of silver which is tissue friendly and better antimicrobial efficiency. There is negligible literature regarding the use of nanocrytalline silver dressing for the management of facial wounds due to mechanical trauma. Hence this study has been designed to test the efficacy of nanocrystalline silver dressing material in facilitating soft tissue healing following trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients indicated for management of soft tissue injuries involving the maxillofacial region due to impact/mechanical injuries.
- •Patients with soft tissue abrasion of size ranging from 1cm to 5cm
- •Patients with soft tissue laceration not requiring suturing and surgical wounds with dehiscence
- •Patients reporting within 24 hours of injury
- •Patients categorized under ASA status I & II.
排除标准
- •Patients aged below 20 years and above 50 years
- •Patients who are allergic to silver
- •Patients presenting with avulsive soft tissue injury, animal bites, chemical injuries, penetrating wounds, wounds with foreign bodies and complex wounds involving vital structures
- •Patients belonging to ASA III, IV, V
- •Patients not willing to be a part of the study.
结局指标
主要结局
1. Healing (assessment of scar formation)
时间窗: 1. Scar formation- 7th day, 14th day, 90th day | 2. Pain- baseline day, 3rd day, 7th day
2. Pain
时间窗: 1. Scar formation- 7th day, 14th day, 90th day | 2. Pain- baseline day, 3rd day, 7th day
次要结局
- 1. Microbial load(2. Patient satisfaction)
研究者
Dishari Basu
SRM Dental College, Ramapuram
