Phase II, Multicentre, Randomized, Controlled, Two Arm, Single Blind Study to Assess Safety and Efficacy of D-PLEX Administered Concomitantly With SOC, Compared to SOC, in Prevention of Post Abdominal Surgery Incisional Infection.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PolyPid Ltd.
- 入组人数
- 202
- 试验地点
- 8
- 主要终点
- The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery
研究概览
简要总结
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care (SOC). The other half will receive the Standard of Care treatment.
Following the surgery subjects will be followed up for additional 5 visits, at least half are in line with the routine practice of surgery Follow-Ups.
Visits will include patient safety and wound assessments.
详细描述
D-PLEX is a new formulation of extended controlled release of Doxycycline in the applied area for about 30 days. This study is aimed to assess the safety and efficacy of D-PLEX in prevention of post abdominal surgery incisional infection.
Eligible and willing subjects will be randomly divided, in a single-blinded manner into 2 study arms D-PLEX with SOC or SOC alone. D-PLEX will be applied during the surgery at the final stage of incision closure. All patients will be followed up for additional 5 visits over 2 months, for safety and incisional wound assessment. This will include blood tests for hematology, chemistry and pharmacokinetics (PK, for some only) as well as physicians assessment of the incisional wound.
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
- Double (Participant, Care Provider)
盲法说明
Subject will be blinded to the treatment arm assignment. Physicians which were not part of the team in the surgery room, or from the hospital's infectious diseases dept. will remain blinded to the study arm, and will be those assessing the incisional wound for the study primary endpoint at each follow-up visit post the index surgery.
On top, for each suspicion of infection, an external, independent and blinded adjudication committee will be the one making the final decision whether an infection occured or not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing elective abdominal colon surgery involving resection and ileocolonic, ileorectal, colocolonic or colorectal anastomosis or with a stoma, who are preoperative stable hemodynamically. In a laparoscopic surgery, an abdominal wall incision ≥ 5 cm should be involved.
- •Male or non-pregnant female.
- •Females of childbearing potential should have a negative serum pregnancy test prior to index procedure. All females of childbearing potential must agree to use a highly effective method of contraception (e.g., double barrier, oral or parenteral hormonal, intrauterine device, or spermicide) consistently and correctly for the duration of the study.
- •Age ≥ 18 years old at screening.
- •Subjects who signed a written informed consent.
- •Willing and able to participate and meet all study requirements.
- •Survival expectancy of at least 60 days post randomization.
排除标准
- •Subjects scheduled for abdominal surgery which is classified as emergency.
- •Subjects with any preoperative active infection that is currently being treated with antibiotics.
- •Subjects receiving any antibiotic therapy in the past 4 weeks prior to enrollment other than prophylaxis or antibiotic for the treatment of the disease for which the surgery is indicated.
- •Subjects undergoing concomitant additional procedures other than colon resection surgery (e.g., hyper-thermic intraperitoneal chemotherapy, liver resection, etc.).
- •Female sterilization surgery (e.g., salpingo-oophorectomy, hysterectomy, etc.), involvement of a small bowel procedure, or cholecystectomy may be allowed, pending an advanced consultation and approval from the sponsor.
- •Subject received chemotherapy within the past 4 weeks of surgery, or radiation for colorectal cancer to the abdominal area, prior to the planned abdominal surgery (neo-adjuvant treatment).
- •Subjects that received oral or IV doxycycline during the past 4 weeks prior to screening.
- •Subjects with known hypersensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX excipients.
- •Subjects with known allergies to more than 3 substances (as determined from allergy questionnaire at screening).
- •Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intravenous steroids/intramuscular epinephrine or in the opinion of the investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions.
- •Subjects with uncontrolled asthma (GINA III-IV).
- •Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
- •Subjects with chronic urticaria.
- •Subjects diagnosed with TIA/CVA/ACS within the past 1 year prior to randomization.
- •Subjects that have undergone any prior abdominal surgery and current planned surgery involves re-opening the scar of the prior abdominal surgery.
- •Any subject with an active malignancy or malignancy that has not been in complete remission for at least 5 years. Excluding:
- •Subjects with potentially resectable non-metastatic colorectal cancer for which the surgery is indicated.
- •Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin, and basal cell carcinoma of the skin.
- •Subjects with non-violent cancer that does not require treatment 4 weeks prior to, and throughout the entire study duration.
- •Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study (e.g., non-GI active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, uncompensated cirrhosis, active upper GI tract ulceration).
- •Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
- •Chronic alcohol or drug abuse.
- •Pregnant or breast-feeding women or women of childbearing age who refuse or are prohibited from using an effective contraceptive method of birth control (e.g., double barrier, oral or parenteral hormonal, intrauterine device, or spermicide) throughout study participation including the safety follow-up period.
- •Subjects that received any investigational drug within 30 days or 5½ half-lives of enrollment in the study (whichever is longer).
- •Subjects participating in any other interventional studies.
- •Any subject who, in the opinion of the investigator, is not eligible to participate in the study and/or comply with protocol requirements (e.g., due to a cognitive or medical condition).
研究组 & 干预措施
Standard of Care (SoC)
SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
干预措施: Standard of Care (SoC) (Other)
D-PLEX + SoC
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
干预措施: Standard of Care (SoC) (Other)
结局指标
主要结局
The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery
时间窗: 30 days post surgery
The infection rate and mortality rate were measured by the number and proportion of subjects with either an SSI event (as determined by the blinded and independent adjudication committee, within 30 days post abdominal surgery) or mortality for any reason within 30 days post index surgery
次要结局
- Average ASEPSIS Assessment Score (for Parameters Additional Treatment, Serous Discharge, Erythema, Purulent Exudate, Separation of Deep Tissue, Isolation of Bacteria, Stay Duration as Inpatient) During 30 Days Post-surgery.(30 days post surgery)
- Mortality Rate Within 30 Days Post Abdominal Surgery(30 days post surgery)