Home › Trials › NCT04411199

Preventing infections after abdominal surgery with D-PLEX

D-PLEX 312 - Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

PHASE3 · PolyPid Ltd. · NCT04411199

This study is testing a new medication called D-PLEX to see if it can help prevent infections after abdominal surgeries in people who are having elective colorectal procedures.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment624 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorPolyPid Ltd. (industry)
Drugs / interventionsimmunotherapy, radiation
Locations68 sites (Augusta, Georgia and 67 other locations)
Trial IDNCT04411199 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the safety and efficacy of D-PLEX, a new formulation of doxycycline, in preventing surgical site infections following elective colorectal surgeries. Participants will be randomly assigned to receive either D-PLEX in addition to standard care or standard care alone. The study involves a double-blind, controlled design, with follow-up assessments over two months to monitor wound healing and safety. The trial aims to determine if D-PLEX can effectively reduce the incidence of infections in patients undergoing significant abdominal procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective colorectal surgery involving a significant incision.

Not a fit: Patients with emergency colorectal surgeries or those with existing complications like intestinal perforation will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of post-operative infections, improving recovery outcomes for patients undergoing abdominal surgery.

How similar studies have performed: Other studies have explored similar antibiotic delivery methods, but the specific use of D-PLEX in this context is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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).
2. 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).
3. Male or non-pregnant female.
4. Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure.
5. Subjects' age 18 years old and above at screening.
6. Subjects who sign the written Informed Consent Form.
7. Subjects who are willing and able to participate and meet all study requirements.
8. Survival expectancy of at least 60 days post randomization.

Exclusion criteria:

1. 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.)
2. Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
3. 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.
4. 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 .
5. Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
6. Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, prior to the planned abdominal surgery.
7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
9. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
10. 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.
11. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
12. Subjects with severe hepatic impairment.
13. Subjects with chronic urticaria.
14. Subjects diagnosed with CVA within the past 6 months prior to randomization.
15. 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.
16. 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.
17. Subjects with other concurrent severe and/or uncontrolled medical condition.
18. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
19. Chronic alcoholic or drug abuse subjects.
20. 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.
21. 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.
22. Subjects participating in any other interventional study.
23. 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).

Where this trial is running

Augusta, Georgia and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection, Surgical site infection, Abdominal surgery, Colon and small bowl surgery

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.