Status:
COMPLETED
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Lead Sponsor:
PolyPid Ltd.
Conditions:
Surgical Site Infection
Colon Surgery
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
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 (So...
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 a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is \>20cm (target incision).
- Subjects are preoperative hemodynamically stable. (BP≤180/110 and \>90/60 mmHg, and HR≤120 and \>60 bpm, and temperature ≤37.50C and \>35.50C).
- Male or non-pregnant female.
- Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) 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.
- Exclusion criteria:
- 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, etc.)
- 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 colorectal resection.
- Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor .
- Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
- Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, within the last 4 weeks of 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 or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years.
- Excluding: Subjects with potentially resectable non-metastatic colorectal cancer, that is the reason for the index surgery.
- Subjects who have had carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin.
- Subjects with any additional non-violent cancer that does not require treatment 4 weeks prior to the surgery, and throughout the entire study duration.
- Subjects with other concurrent severe and/or uncontrolled medical condition.
- 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).
Exclusion
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2025
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04411199
Start Date
December 15 2020
End Date
May 10 2025
Last Update
June 10 2025
Active Locations (58)
Enter a location and click search to find clinical trials sorted by distance.
1
Augusta Univeristy
Augusta, Georgia, United States, 30912
2
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033