D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional… (NCT04411199) | Clinical Trial Compass
CompletedPhase 3
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
United States, Bosnia and Herzegovina, Georgia975 participantsStarted 2020-12-15
Plain-language 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 (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >20 cm
. Survival expectancy of at least sixty 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 six months prior to randomization.
. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past one week prior to randomization, excluding pre-operative prophylaxis or antibiotics for the treatment of the disease that is the indication for surgery.
. 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 four weeks of surgery.
. Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, within the last four weeks of the planned abdominal surgery.
. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past four 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.