Post Market Clinical Follow Up Study of Absorbable Sutures
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Absorbable Surgical Suture.
研究概览
简要总结
Post-market clinical follow-up studies are performed on a device within its intended use/purpose(s) according to the instructions for use. It is important to note that PMCF studies must be conducted according to applicable laws and regulations and should involve an appropriate methodology and follow appropriate guidance and standards. It is a precondition for placing a product on the market that conformity to the relevant Essential Requirements, including a favorable benefit/risk ratio, has been demonstrated. The PMCF is recommended also due to there may be limitations to the clinical data available in the pre-market phase. Such limitations can be addressed in Post market clinical follow up studies. The extent of the data that will be gathered in the pre-market phase does not necessarily enable the manufacturer to detect rare complications or problems that only become apparent after wide-spread or long-term use of the device.
There are 5 types of absorbable sutures for the study
The product name and their intended use are given below:
| SI.NO |
PRODUCT NAME
INTENDED USE
|1.
Coated & Braided absorbable Polyglycolic Acid Sutures
Petcryl® sutures are indicated for use in general soft tissue approximation and in general surgery.
|2.
Coated and braided polyglactin 910 suture, absorbable surgical suture
Petcryl® 910 suture is indicated for use in general soft tissue approximation and/or ligation.
|3.
Coated and braided polyglactin 910 fast suture, absorbable surgical suture
Petcryl® 910 Fast suture is indicated for use in general soft tissue approximation and/or ligation where only short time tissue approximation is required.
|4.
Monofilament polydioxanone absorbable surgical suture
Duracryl sutures are indicated for use in all types of soft tissue approximation.
|5.
Monofilament poliglecaprone 25 absorbable surgical Suture
Petcryl® Mono sutures are indicated for use in general soft tissue approximation and/or ligation.
The primary objective of this postmarket clinical study is to assess the clinical performance, safety andacceptability of the Absorbable Surgical Suture.
Endpoints
- Quantitativedetermination of soft tissue approximation/ligation and wound closure action byusing the Absorbable surgical suture
- Occurrence ofwound reopening
- Occurrence ofwound re-rupturing after hand surgery
- Any signs ofsuperficial infection after surgery – Redness, Pus, Swelling
- Ease of use usingLikert’s scale (1-5)
The Secondary Objective is todetermine any undesirable events under normal condition of use and identify thepresence of any new emergent risks, known and unknown residual risk. The studywill focus on identifying possible systematic misuse or off-label use of thedevice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent from the subject Subjects using the absorbable sutures for general surgery, soft tissue approximation and ligation.
- •Adult patient who are ≥ 18 age.
排除标准
- •Subjects without informed consent from the subject.
- •Subject in which extended approximation of tissues under stress is required.
- •Subject who are sensitive or allergic to the raw materials of the sutures.
结局指标
主要结局
The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Absorbable Surgical Suture.
时间窗: 6 to 12 months
Endpoints
时间窗: 6 to 12 months
-Quantitative determination of soft tissue approximation/ligation and wound closure action by using the Absorbable surgical suture
时间窗: 6 to 12 months
-Ease of use using Likert’s scale (1-5)
时间窗: 6 to 12 months
-Occurrence of wound reopening
时间窗: 6 to 12 months
-Occurrence of wound re-rupturing after hand surgery
时间窗: 6 to 12 months
-Any signs of superficial infection after surgery – Redness, Pus, Swelling
时间窗: 6 to 12 months
次要结局
- The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device.(6 to 12 months)