Prospective Randomized Trial Comparing Outcomes Of Episiorrhaphy Using Vicryl Rapid Coated 2/0 Versus Vicryl 2/0 Plus Triclosan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain evaluation
研究概览
简要总结
An episiotomy refers to the incision of the perineum performed to increase the space of the vaginal opening to facilitate the birth of the newborn. Subsequently, the incision is closed by aligning the tissues without cutaneous and vascular alterations. Although a systematic review and metanalysis demonstrated that sutures coated with triclosan, a purified antimicrobial, prevent surgical site infections, there is no evidence in the literature regarding the use of antibacterial sutures for perineal plane compared to standard ones.
Therefore, the goal of this clinical trial is to compare the outcomes of incisions performed with standard Vicryl 2/0 sutures and antibacterial Vicryl Plus 2/0 sutures.
The study involves women giving birth at the Vittore Buzzi Children's Hospital, for whom an incision is necessary at the time of delivery. Participants will be evaluated at 48 hours (at the time of the hospital discharge visit), 40 days (at the postpartum visit), and 6 months (by phone interview) after delivery.
In particular, the aim of this study is to assess whether:
- antibacterial Vicryl Plus 2/0 sutures reduce pain after delivery;
- antibacterial Vicryl Plus 2/0 sutures improve the overall wound healing rate, avoid sexual, urinary or bowel disorders and the need for additional pharmacological, surgical, or physiotherapeutic interventions (in case of suboptimal wound healing).
This study also aims to validate a new ASEPSIS ( Additional Treatment, Serous exudate, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria and Stay) score for the evaluation of healing outcomes of episiotomies.
This is a double-blind, parallel-group randomized controlled trial. After obtaining informed consent, participants are randomly assigned either to the experimental group or the control group. Participants do not know the group they belong to, as the researchers; only the healthcare professional performing the suture knows it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women at term (more than 37 weeks);
- •age between 18 and 40 years;
- •women who give consent to participate in the study;
- •women who give birth during the recruitment period;
- •women for whom an episiotomy is necessary at the time of delivery.
排除标准
- •age lower than 18 years and more than 40 years;
- •gestational age lower than 37 weeks;
- •diabetes mellitus or gestational diabetes;
- •African and South-East Asian ethnicities;
- •cigarette smoking;
- •BMI higher than 30;
- •lack of consent to participate;
- •complicated episiotomy and/or presence of other spontaneous perineal lacerations;
- •women lost to follow-up or who have undergone non-gynecological perineal interventions during the follow-up period.
结局指标
主要结局
Pain evaluation
时间窗: 48 hours, 40 days and six months postpartum.
Pain is defined through a Swab test (based on a pain scale known as the Visual Analogue scale (VAS) with a score from 0 to 10 (0= no pain, 10=worst imaginable pain)
次要结局
- Functional disorders secondary to episiotomy repair(Assessed at 6 months postpartum)
- Re-suturing(at 48 hours and 40 days after delivery)
- Wound Healing Status Assessed by ASEPSIS Score(48 hours, 40 days and six months postpartum.)
- Functional disorders secondary to episiotomy repair(Assessed at 6 months postpartum)
研究者
Valeria Maria Savasi
Professor
ASST Fatebenefratelli Sacco