D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PolyPid Ltd.
- 入组人数
- 977
- 试验地点
- 119
- 主要终点
- To Assess the Anti-infective Efficacy of D-PLEX Over a Period of 30 Days Post Operation, by Preventing Surgical Site Infection (SSI), Defined as Superficial and Deep Infection, in the Target Incision(s), Compared to the SoC Treated Control.
研究概览
简要总结
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated control arm, in prevention of post abdominal surgery incisional infection.
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.
The study population includes male and female, 18 years old and above at screening, undergoing an elective colorectal surgery involving resection, with or without a stoma, that includes at least 1 incision that is > 10 cm (target incision). Eligible and willing subjects will be randomly allocated into 2 blinded 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 and chemistry well as physicians assessment of the incisional wound.
The final number of subjects will be determined following a comparative interim analysis for an early efficacy or futility stop or unblinded sample size re-estimation: when about 750 subjects will complete their 30 days (1 month) follow-up and evaluated for primary endpoint
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind clinical trial. The sponsor, the subjects, outcomes assessor and all staff involved in the collection and recording of the clinical and laboratory data, based on which the independent adjudication committee will perform their assessment, will be blind to treatment assignment. In addition, all aspects of data management and clean-up will be done in blinded datasets.
The study site personnel, who perform the index surgery (Operation room staff), will be trained not to disclose the treatment arm to the blinded Investigator, to the subject, his/her family, to other health care providers not present during the surgery or to the study Sponsor representatives. Wound assessment throughout the study follow-up visits will be done by a blinded Investigator, that will not be involved in the surgery. An emergency card containing the Study Name, NIH number, Center Name/number, PI's name and contact details will be provided to the subjects.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is > 10cm (target incision).
- •Subjects are preoperative hemodynamically stable
- •Male or non-pregnant female.
- •Female of child-bearing potential should have a negative pregnancy test prior to index procedure.
- •Subjects' age 18 years old and above at screening.
- •Subjects who sign the written Informed Consent Form.
- •Subjects who are willing and able to participate and meet all study requirements.
- •Survival expectancy of at least 60 days post randomization
排除标准
- •Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis, volvulus, ect.)
- •Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
- •Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre-operative prophylaxis.
- •Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
- •Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
- •Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
- •Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
- •Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
- •Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
- •Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions.
- •Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
- •Subjects with severe hepatic impairment.
- •Subjects with chronic urticaria.
- •Subjects diagnosed with CVA within the past 6 months prior to randomization.
- •Subjects who underwent any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years.
- •Any subject with an active malignancy, other than resectable non-metastatic colorectal cancer, that is the reason for the index surgery, or carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin, or a malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years.
- •Subjects with other concurrent severe and/or uncontrolled medical conditions.
- •Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
- •Chronic alcoholic or drug abuse subjects.
- •Pregnant or breast-feeding women or women of child-bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period.
- •Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study.
- •Subjects participating in any other interventional study.
- •Subjects, who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).
研究组 & 干预措施
Standard of care
The SoC for prophylactic antibiotic treatment is based on international guidelines
干预措施: Standard of Care (SoC) (Drug)
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) (Drug)
D-PLEX+SoC
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
干预措施: D-PLEX (Drug)
结局指标
主要结局
To Assess the Anti-infective Efficacy of D-PLEX Over a Period of 30 Days Post Operation, by Preventing Surgical Site Infection (SSI), Defined as Superficial and Deep Infection, in the Target Incision(s), Compared to the SoC Treated Control.
时间窗: By day 30 post surgery
Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post-abdominal surgery. \[Abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\]. The blinded and independent adjudication committee review will include all index surgery incisions, regardless of any re-intervention at the target site, for the determination of infection status. The committee will also assess re-interventions at the primary incision site through the abdominal incision (target) for the determination of re-intervention due to suspected SSI or due to poor wound healing, including wound dehiscence. Such events, as well as all-cause mortality within 30 days post-index surgery will be analyzed as treatment failure.
次要结局
- Infection Rate(30 days post-surgery)
- Assessment of Infection Rate in Patient Undergoing Abdominal Colon Surgery(30 days post-surgery)