Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- incidence of combined postoperative complications Grade I and Grade II
研究概览
简要总结
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients
详细描述
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients.
The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients undergoing mucosal wound closure using Dafilon as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be included).
- •Written informed consent regarding the data collection for the PMCF.
排除标准
- •Emergency surgery.
- •Oral surgery procedures requiring bone regeneration.
- •Pregnancy.
- •Patients taking medication that might affect wound healing.
- •Patients with hypersensitivity or allergy to the suture material.
结局指标
主要结局
incidence of combined postoperative complications Grade I and Grade II
时间窗: 10 ± 5 days postoperatively (suture removal)
combined incidence of postoperative complications Grade I \& II on a Five Point scale defined by Askar et al. (Grade I: postoperative dentinal hypersensitivity / Oral candidiasis / Angular cheilitis / Exaggerated swelling defined as postoperative enlargement of tissues that exceeds the normal limits associated with a given surgical procedure / Delayed wound healing defined as an unusual deviation from the normal course of healing / Mild postoperative bleeding defined as the presence of small amount of blood in the oral cavity, usually mixed with saliva; Grade II: Flap dehiscence / Membrane exposure / Localized infection of the surgical site / Graft necrosis)
次要结局
- Wound healing assessment using the visual analogue scale (VAS 1-100)(at suture removal 10 ± 5 days postoperative)
- Incidence of individual postoperative complications(until suture removal 10 ± 5 days postoperative)
- pliability(intraoperative)
- Satisfaction of the patient using the visual analogue scale (VAS 1-100)(at suture removal 10 ± 5 days postoperative)
- tensile strength(intraoperative)
- knot run down(intraoperative)
- knot security(intraoperative)
- Pain assessment using the visual analogue scale (VAS 1-100)(at suture removal 10 ± 5 days postoperative)
- tissue drag(intraoperative)