A prospective study to assess the safety and performance of the non-absorbable sutures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 3
- 主要终点
- Safety of the non-absorbable suture is assessed by monitoring
研究概览
简要总结
Title of Study:A prospective study to assess the safety and performance of
the non-absorbable sutures
Type of Study:The study will be a prospective, interventional, multi-centric
and open label study.
Study Period:6 Months
Results:
Monofilament Polyamide (Nylon) Sterile Non- Absorbable Surgical Suture U.S.P
A total of 46 subjects were recruited in the clinical study. Among the 46 enrolled subjects, 25 (54%) were male and 21 (46%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants — with and without a needle.
The clinical safety parameter analysis of Monofilament Polyamide (Nylon) Non-Absorbable Surgical Suture indicates that users have provided consistently favourable responses across all use cases, supporting its clinical safety profile.
The majority of users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Monofilament Polyamide (Nylon) Non-Absorbable Surgical Suture provided below mentioned clinical benefits during the study:
-
Provide excellent tissue support for wound healing
-
Adequate tensile strength, which ensures that the suture remains intact during the healing process
-
Good knot security
No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 46 subjects. All 46 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the majority of users rated the product’s performance as good, indicating consistent and satisfactory performance across applications.
In all use cases, the majority of users rated their overall satisfaction with the product as good, reflecting a positive user experience.
Braided & Coated Polyester sterile Non-Absorbable Surgical Suture U.S.P
A total of 35 subjects were recruited in the clinical study. Among the 35 enrolled subjects, 19 (54%) were male and 16 (46%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants, with and without a needle.
The clinical safety parameter analysis of Braided & Coated Polyester sterile Non-Absorbable Surgical Suture U.S.P indicates that users have provided consistently favourable responses across all use cases, supporting its clinical safety profile.
All the users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Braided & Coated Polyester sterile Non-Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
-
Provide excellent tissue support for wound healing
-
Adequate tensile strength, which ensures that the suture remains intact during the healing process
-
Good knot security
No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 35 subjects. All 35 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, the users rated their overall satisfaction with the product as good, reflecting a positive user experience.
Monofilament Polypropylene Sterile Non-Absorbable Surgical Suture U.S.P
A total of 46 subjects were recruited in the clinical study. Among the 46 enrolled subjects, 25 (54%) were male and 21 (46%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants, with and without a needle.
The clinical safety parameter analysis of Monofilament Polypropylene Sterile Non -Absorbable Surgical Suture U.S.P indicates that users have provided consistently favourable responses across all use cases, supporting its clinical safety profile.
The majority of users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Monofilament Polypropylene Sterile Non -Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
-
Provide excellent tissue support for wound healing
-
Adequate tensile strength, which ensures that the suture remains intact during the healing process
-
Good knot security
No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 46 subjects. All 46 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the majority of users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, the majority of users rated their overall satisfaction with the product as very good, reflecting a positive user experience.
Black Braided Silk Sterile Non-Absorbable Surgical Suture U.S.P
A total of 45 subjects were recruited in the clinical study. Among the 45 enrolled subjects, 21 (47%) were male and 24 (53%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favorable responses for both suture variants, with and without a needle.
The clinical safety parameter analysis of Black Braided Silk Non-Absorbable Surgical Suture indicates that users have provided consistently favorable responses across all use cases, supporting its clinical safety profile.
The majority of users have rated the performance of the suture product as good, suggesting overall user satisfaction.
Black Braided Silk Non-Absorbable Surgical Suture provided below mentioned clinical benefits during the study:
-
Provide excellent tissue support for wound healing
-
Adequate tensile strength, which ensures that the suture remains intact during the healing process
-
Good knot security
No complications or adverse events were observed during the first follow-up visit, second follow-up visit and third follow-up (telephonic follow-up) for all 45 subjects. All 45 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, the majority of users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, the majority of users rated their overall satisfaction with the product as very good, reflecting a positive user experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants adult , irrespective of the gender 2.Subjects requiring surgical procedures where non absorbable sutures are indicated.
- •use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurosurgical tissues. 3.Subject willingness to provide informed consent and comply with study procedures and follow-up visits.
排除标准
- •â€¢ Presence of chronic diseases that could impair healing, such as diabetes mellitus, immune disorders or chronic steroid use • Known allergy to suture material or any components used in the suturing process.
结局指标
主要结局
Safety of the non-absorbable suture is assessed by monitoring
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
adverse events during periodic follow-up visits -
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
• local inflammatory tissue reaction
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
• local transitory irritation in response to foreign body
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
• erythema or induration
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
• wound dehiscence
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
• suture sinus
时间窗: A total of 3 follow-up visits are performed on day 7, day 30 and day 100. | During this period assessments of each subject at different visits shall be recorded in the CRF.
次要结局
- Performance of the non-absorbable suture is evaluated both intraoperative and(postoperative.)
研究者
Dr Niranjan P
Sagar Hospitals jayanagar