D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional … (NCT03633123) | Clinical Trial Compass
CompletedPhase 2
D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Israel202 participantsStarted 2018-10-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Subjects scheduled for abdominal surgery which is classified as emergency.
What they're measuring
1
The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery
✕. 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.).
✕. 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).