Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04411199 | D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II) | PHASE3 | COMPLETED | 800 | — | — | Dec 15, 2020 | May 10, 2025 | Jun 10, 2025 | 58 | United States, Bosnia and Herzegovina +11 |
| NCT04233424 | D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection | PHASE3 | COMPLETED | 977 | — | — | Jun 24, 2020 | Sep 2, 2022 | Apr 21, 2026 | 62 | United States, Bulgaria +8 |
Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery. \[abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\].within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee. All-cause mortality and re-interventions in the target incision within 30 days post index surgery will be analysed as treatment failure. Incisional infection event only, occurred within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee. \[abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)\].
Safety parameters will be evaluated by adverse events
Incisional wound healing will be assessed by a blinded Investigator, using a visual examination as well as Modified Vancouver Scar Scale wound assessment questionnaires. The questionnaire has a numeric scale from 0-4 in Vascularity, Pigmentation, Pliability and height
| Arm | Type | Description |
|---|---|---|
| D-PLEX+SoC | EXPERIMENTAL | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment |
| Standard of Care | OTHER | The SoC for prophylactic antibiotic treatment is based on international guidelines |
| Name | Type | Description |
|---|---|---|
| D-PLEX | DRUG | D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable. |
| Standard of Care (SoC) | OTHER | prophylactic, pre-operation per institution guidelines |
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≤1...