A prospective study to assess the safety and performance of the 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
- 2
- 主要终点
- Safety of the 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 absorbable sutures. .
Type of Study-The study will be a prospective, interventional, multi-centric
and open label study.
Study Period-6 Months
Results:
Monofilament Polydioxanone Sterile Synthetic Absorbable Surgical Suture-
A total of 60 subjects were recruited in the clinical study. Among the 60 enrolled subjects, 29(48%) were male and 31(52%) 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 Polydioxanone Sterile Synthetic Absorbable Surgical Suture 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.
Monofilament Polydioxanone Sterile Synthetic Absorbable Surgical Suture provided below mentioned clinical benefits during the study:
-
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, second and the third (telephonic follow-up) and fourth follow up (telephonic follow-up) for all 60 subjects. All 60 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, all the users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, all the users rated their overall satisfaction with the product as very good, reflecting a positive user experience.
Braided & Coated Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture U.S.P-
A total of 61 subjects were recruited in the clinical study. Among the 61 enrolled subjects, 32(52%) were male and 29(48%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants - with and without needle.
The clinical safety parameter analysis of Braided & Coated Polyglactin 910 Sterile Synthetic 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 Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
-
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 61 subjects. All 61 subjects who completed the evaluation demonstrated complete healing of the surgical site.
In all use cases, all the users rated the product’s performance as very good, indicating consistent and satisfactory performance across applications.
In all use cases, all the users rated their overall satisfaction with the product as very good, reflecting a positive user experience.
Braided & Coated Polyglycolic Acid Sterile Synthetic Absorbable Surgical Suture U.S.P-
A total of 61 subjects were recruited in the clinical study. Among the 61 enrolled subjects, 32(52%) were male and 29(48%) were female.
The product fulfilled its intended use across all evaluated cases, with users providing favourable responses for both suture variants - with and without needle.
The clinical safety parameter analysis of Braided & Coated Polyglycolic Acid Sterile Synthetic 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 Polyglycolic Acid Sterile Synthetic Absorbable Surgical Suture U.S.P provided below mentioned clinical benefits during the study:
-
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 61 subjects. All 61 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 absorbable sutures are indicated.
- •use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery. 3.Subject willingness to provide informed consent and comply with study procedures and follow-up visits.
排除标准
- •1.Presence of chronic diseases that could impair healing, such as diabetes mellitus, immune disorders or chronic steroid use 2.Known allergy to suture material or any components used in the suturing process 3.Cardiovascular and neurological tissues suturing 4.Vulnerable population such as lactating mothers, pregnant women and pediatric population.
结局指标
主要结局
Safety of the absorbable suture is assessed by monitoring
时间窗: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | 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: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | During this period assessments of each subject at different visits shall be recorded in the CRF.
• local inflammatory tissue reaction
时间窗: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | 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: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | During this period assessments of each subject at different visits shall be recorded in the CRF.
• erythema or induration
时间窗: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | During this period assessments of each subject at different visits shall be recorded in the CRF.
• wound dehiscence
时间窗: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | During this period assessments of each subject at different visits shall be recorded in the CRF.
• sututre sinus
时间窗: Subjects will have regular follow-up | appointments with the investigator, post-operative on Day 7, | Day 30 and telephonic follow up on Day 100 and Day 180( | applicable only for Monofilament Polydioxanone Absorbable | Surgical Suture). | During this period assessments of each subject at different visits shall be recorded in the CRF.
次要结局
- Performance of the absorbable suture is evaluated both(intraoperative and postoperative.)
研究者
Dr Niranjan P
Sagar Hospitals jayanagar