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Trial record 3 of 3 for:    d-plex

Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

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ClinicalTrials.gov Identifier: NCT03633123
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
PolyPid Ltd.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abdominal Surgery Colon Surgery Post-Op Infection Drug: D_PLEX Other: Standard of Care (SoC) Phase 2

Detailed Description:

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 manor 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 PK (for some only) as well as physicians assessment of the incisional wound.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Males and females, >18 years old, undergoing scheduled abdominal colon surgery involving resection and anastomosis or a stoma, who meet the inclusion criteria and none of the exclusion criteria and provide signed informed consent will be enrolled in the study.

Subjects will be randomized to either the investigational arm (SOC + D-PLEX) or to the control arm (SOC only) in a 1:1 ratio.

Subjects will be blinded to the study arm.

Masking: Single (Participant)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
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.
Other: Standard of Care (SoC)

Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.

Post-operation: this is each participating center standard practice for this type of procedure


Experimental: D-PLEX + SoC
D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
Drug: D_PLEX
D_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).

Other: Standard of Care (SoC)

Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.

Post-operation: this is each participating center standard practice for this type of procedure





Primary Outcome Measures :
  1. Infection rate as measured by the proportion of subjects with abdominal incisional infection event [ Time Frame: By day 30 post surgery ]
    Infection rate as measured by the proportion of subjects with abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery.


Secondary Outcome Measures :
  1. Average ASEPSIS assessment score (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay duration as inpatient) during 30 days post-surgery. [ Time Frame: At post surgery study visits : day 1, day 5, day 14 & day 30 ]

    ASEPSIS is acronym of wound assessment and treatment parameters (described in the title), which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection.

    Each parameter will be evaluated and numerically scored. Some (Serous discharge & Erythema) will be marked between 0 - 5 and others (Purulent exudate & Separation of deep tissue) are marked between 0 - 10 - based on the proportion of the wound they affect when 0 is none and either 5 or 10 are for over 80% of the wound.

    Other parameters (Additional antibiotic treatment, a requirement for pus drainage, solation of bacteria & Stay duration as an inpatient) are scored Yes or No. No equals 0. Yes is calculated as either 5 points (for some parameters) or 10 for others.

    The final score can in the range of 0 - 70. 0 - 10 for wound which heals satisfactorily and over 40 for a severe wound infection.


  2. Incidence of Deep Surgical Site Infection during 30 days post-surgery [ Time Frame: At study visits: day 1, day 5, day 14 and day 30 post surgery ]
    Number of deep surgical site infections events during the 30 days post surgery, as confirmed by an independent adjudication committee.

  3. Incidence of Superficial Surgical Site Infection during 30 days post-surgery [ Time Frame: At study visits: day 1, day 5, day 14 and day 30 post surgery ]
    Number of superficial surgical site infections events during the 30 days post surgery, as confirmed by an independent adjudication committee.

  4. Mortality rate within 60 days post abdominal surgery [ Time Frame: During 60 days of study participation ]
    Death from any reason

  5. Susceptibility to Doxycycline [ Time Frame: At study visits: day 1, day 5, day 14 and day 30 post surgery ]

    Susceptibility to Doxycycline for any organisms recovered from an abdominal surgery incisional Infection site will be done using a central lab.

    When an infection is suspected in the incisional wound, a sample will be taken and sent for a bacteriology test in a central lab. Any organism which will grow (if), will be further tested for Doxycycline susceptibility.


  6. Number of overall hospitalization days post surgery [ Time Frame: During 60 days of study participation ]
    Number of hospitalization days after surgery and until discharge. Will include prolongation of primary hospitalization compared to the average of the rest of the recruited patients and re-admission due to infection

  7. Number of antibiotic treatment days post surgery [ Time Frame: During 60 days of study participation ]
    Number of days antibiotic treatment is administered (any route) to treat an incisional infection.

  8. Time to surgical site infection [ Time Frame: At study visits: day 1, day 5, day 14 and day 30 post surgery ]
    Number of days between surgery and a confirmed incisional surgery infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects undergoing elective abdominal colon surgery involving resection and anastomosis or a stoma.
  2. Male or non-pregnant female Female of childbearing potential should have a negative serum pregnancy test prior to index procedure and agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
  3. Subjects who sign a written informed consent
  4. Subjects who are willing and able to participate and meet all study requirements.

Exclusion Criteria:

  1. Subjects scheduled for abdominal surgery which is classified as emergency.
  2. Subjects with any preoperative active infection that is currently being treated with antibiotics, excluding Gastrointestinal (GI) infections.
  3. Subjects receiving any antibiotic therapy in the past 4 weeks prior to enrolment besides prophylaxis or antibiotic for the treatment of the disease that consists the indication for surgery.
  4. Patients undergoing concomitant additional procedures besides colon resection surgery, e.g. Hyper-thermic Intraperitoneal Chemotherapy, liver resection etc. Female sterilization surgery (i.e. salpingo-oophorectomy, hysterectomy etc.), or involvement of a small bowel procedure or Cholecystectomy may be allowed, pending an advanced consultation and approval from the sponsor.
  5. Subject received chemotherapy within the last 4 weeks of surgery, or radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery (neo- adjuvant treatment).
  6. Subjects that received oral or IV doxycycline during the past 4 weeks prior to screening.
  7. Subjects with known sensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
  8. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled in during the screening process).
  9. Subjects with a 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 patient is at high risk of developing severe allergic/hypersensitivity reactions.
  10. Subjects with uncontrolled Asthma (GINA III-IV).
  11. Subjects with End Stage Renal Disease [Chronic Kidney Disease (CKD) stage 5].
  12. Subjects with chronic urticaria.
  13. Subjects diagnosed with severe neurological/cardiac events within the past 1 year prior to randomization.
  14. Subjects that undergone any abdominal surgery and current planned surgery involves re-opening the scar of prior abdominal surgery.
  15. Any subject with active malignancy or with malignancy that has not been in complete remission for at least 5 years.

    Excluding:

    • subjects with potentially resectable non-metastatic colorectal cancer which consists the indication for surgery. In addition,
    • patients Patients who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma of the skin
    • Non-violent cancer that does not require treatment 4 weeks prior to, and throughout the entire study duration will be eligible.
  16. 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 gastrointestinal (GI) tract ulceration).
  17. Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
  18. Chronic alcoholic or drug abuse subjects.
  19. Pregnant or breast-feeding women or women of childbearing age who refuse or prohibited of using an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) throughout study participation including safety follow-up period.
  20. Subjects that received any investigational drug within 30 days or 5½ half-lives of enrollment to the study (whichever is longer).
  21. Subjects participating in any other interventional studies.
  22. In the opinion of investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g. due to a cognitive or medical condition).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633123


Contacts
Contact: Iris Gelber, CPM +972 74 7195700 iris.g@polypid.com
Contact: Olga Belotsrekovsky, CDM +972 74 7195700 olga.b@polypid.com

Locations
Israel
Meir MC Not yet recruiting
Kfar Saba, Israel
Contact: Liron Berkovich    09-7472162    liron.berkovich@gmail.com   
Principal Investigator: Shmuel Avital, Prof.         
Rabin MC, Campus Beilinson Recruiting
Petach Tikva, Israel
Contact: Or Haim    +972 3 9376258    orha1@clalit.org.il   
Principal Investigator: Nir Wasserberg, Prof.         
Sheba MC, Tel-Hashomer Recruiting
Ramat Gan, Israel
Contact: Gal Levi    +972 3 5307595    gal.levi@sheba.health.gov.il   
Principal Investigator: Lior Segev, Dr.         
Kaplan MC Not yet recruiting
Reẖovot, Israel
Contact: Orit Mosko    08-9441393    oritmo22@clalit.org.il   
Principal Investigator: Guy Lin, Dr.         
Assuta Ramat-HaHayal Not yet recruiting
Tel Aviv, Israel
Contact: Osnat Elbak    03-7645282    osnatalb@assuta.co.il   
Principal Investigator: Sergio Susmallian, Dr.         
Tel-Aviv Sourasky MC Not yet recruiting
Tel Aviv, Israel
Contact: Anat Weizman    +972 3 6973209    anatw@tlvmc.gov.il   
Principal Investigator: Hagit Tulchinsky, Prof.         
Assaf-Harofeh MC Recruiting
Zrifin, Israel
Contact: Yishrat Elinson    +972 8 9542447    yishrat.asaf@gmail.com   
Principal Investigator: Oded Zmora, Prof.         
Sponsors and Collaborators
PolyPid Ltd.
Investigators
Study Director: Noam Emanuel, Dr. Chief Scientist

Responsible Party: PolyPid Ltd.
ClinicalTrials.gov Identifier: NCT03633123     History of Changes
Other Study ID Numbers: D-PLEX 310
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PolyPid Ltd.:
Surgical site infection
Abdominal surgery
Colon and small bowl surgery

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes