Randomised Controlled Trial Evaluating Dialkylcarbamoyl Chloride (DACC) Impregnated Dressings for the Prevention of Surgical Site Infections in Adult Women Undergoing Caesarean Section.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 543
- 试验地点
- 1
- 主要终点
- Percentage of patients with surgical site infection
研究概览
简要总结
Surgical site infections (SSIs) constitute an important medical and socioeconomic problem worldwide. Despite the fact that the risk factors for SSIs were identified and the continuously increasing medical knowledge in the fields of tissue engineering, molecular biology and microbiology facilitated the development of numerous new recommendations and methods for management, in many cases the available options for successful treatment of post-operative wound infections remain limited. Non-treated or inappropriately treated SSIs often lead to necrosis of the surrounding tissues, wound dehiscence, formation of fistulas, or become sites of origin for systemic infections. Patients are exposed to risk of further complications and hospitalization time extends resulting in increased total treatment costs. Treatment prolongation affects also the quality of life and psychosocial functioning of patients with impaired wound healing. Considering the arguments above, appropriate prevention and management of infected post-surgical wounds is currently one of the priorities for the majority of invasive medical disciplines.
Obstetrics constitute a field of medicine in which the issues associated with wound healing are particularly relevant. According to the literature data wound infections occur in approximately 1.8-11.3% of women undergoing caesarean section.
Dialkylcarbamoyl chloride (DACC) is a fatty acid derivative that irreversibly binds microorganisms to the dressing fibres as a result of hydrophobic interaction. As the mechanism of DACC action is solely physical no chemical agents are released into the wound bed and the dressing could be safely used by women during puerperal period.
The purpose of this randomized controlled study is to compare the effect of DACC impregnated dressing and standard surgical dressing in the prevention of SSIs in adult women following caesarean section. This study will also evaluate pre-, peri- and postoperative risk factors of SSIs and analyze health economics of DACC impregnated dressings for prevention of post-cesarean wound infections.
详细描述
This is a single-blinded randomized controlled trial performed at the Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will involve 518 patients undergoing caesarean section who after giving their informed consent will be randomly divided into two groups: study (n=259) and control group (n=259). The study group will receive DACC impregnated dressing - Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) and the control group will receive standard surgical dressing.
In all participants transverse skin incision and low transverse uterine incision will be performed during caesarean section procedure.
All participants will receive prophylactic dose of antibiotics prior to the start of surgery (1g cefazolin intravenously 0-30 minutes before surgery) and wound irrigation with octenidine prior to the subcutaneous tissue closure.
For fascial incision, subcutaneous tissue and skin incision closure continuous antibacterial braided absorbable suture, single monofilament absorbable suture and subcuticular continuous monofilament non-absorbable suture will be used, respectively.
Dressing will be left in place for the first 48 hours post caesarean section unless clinical reason exists to replace it. After the first 48 hours postoperatively all of the dressings will be removed and first wound evaluation will be performed. On post-operative day 3 patients will be discharged and indicated to revisit on post-operative day 7 to remove the skin suture. During this follow-up visit second wound review will be performed for any signs of infection. Third, and final wound assessment will take place on post-operative day 14.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •undergoing elective or emergency caesarean section
- •transverse skin incision
- •low transverse uterine incision
- •single and multiple pregnancy
- •intravenous administration of 1g cefazolin 0-30 minutes prior to the start of surgery
- •irrigation of the wound with octenidine prior to the subcutaneous tissue closure
排除标准
- •patients age <18 years
- •patients physical or mental incapacity to give informed consent
- •skin incision other than transverse
- •uterine incision other than low transverse
- •patients that did not receive routine prophylactic dose of antibiotics prior to the start of surgery
- •patients without irrigation of the wound with octenidine prior to the subcutaneous tissue closure
研究组 & 干预措施
DACC impregnated dressing
Patients undergoing elective or emergency caesarean section with DACC impregnated dressing Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively
干预措施: DACC impregnated dressing (Device)
Standard surgical dressing
Patients undergoing elective or emergency caesarean section with standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively
干预措施: Standard surgical dressing (Device)
结局指标
主要结局
Percentage of patients with surgical site infection
时间窗: within the first 14 days post surgery
SSI determined according to Centers for Disease Control and Prevention (CDC) criteria
次要结局
- Pathogens responsible for SSI(within the first 8 weeks post surgery)
- Surgeons experience(Day 0 (day of surgery))
- Length of surgery(Day 0 (day of surgery))
- Mode of caesarean section(Day 0 (day of surgery))
- Percentage of patients with SSI associated wound dehiscence(within the first 8 weeks post surgery)
- Length of the primary and any secondary hospitalization(Day 0 (day of surgery/ the first day of readmission to hospital) until the date of discharge, up to 8 weeks post surgery)
- Readmissions to hospital due to SSI following caesarean section(within the first 8 weeks post surgery)
- Percentage of patients with antibiotic treatment due to SSI following caesarean section(within the first 8 weeks post surgery)
- Patients parity(Day 0 (day of surgery))
- Patients pre-gestational weight(Day 0 (day of surgery))
- Patients pre-gestational body mass index(Day 0 (day of surgery))
- Patients gestational weight gain(Day 0 (day of surgery))
- Percentage of patients with nicotine dependence(Day 0 (day of surgery))
- Percentage of patients with gestational diabetes mellitus or pre-gestational diabetes mellitus(Day 0 (day of surgery))
- Patients haemoglobin concentration prior to the start of surgery(Day 0 (day of surgery))
- Patients haemoglobin concentration after the surgery(24 hours after surgery)
- Percentage of patients with surgical intervention due to SSI(within the first 8 weeks post surgery)
- Patients age(Day 0 (day of surgery))
- Patients race(Day 0 (day of surgery))
研究者
Paweł Stanirowski
Doctor of Medicine
Medical University of Warsaw