D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional … (NCT04233424) | Clinical Trial Compass
CompletedPhase 3
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
United States977 participantsStarted 2020-06-24
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 range18 Years – 99 Years
SexALL
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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 \> 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
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, 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.
✕
What they're measuring
1
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.
. 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.