Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

D-PLEX is a new formulation of extended controlled release of Doxycycline in the applied area for about 30 days. This study is aimed to assess the safety and efficacy of D-PLEX in prevention of post abdominal surgery incisional infection. The study population includes male and female, 18 years old and above at screening, undergoing an elective colorectal surgery involving colon or rectal resection, with or without a stoma formation, that includes at least 1 incision that is > 20cm (target incision). Eligible and willing subjects will be randomly allocated into 2 blinded study arms, either to the investigational arm (D-PLEX + SoC) or to the control arm (SoC only) in a 1:1 ratio. Subjects will be stratified by type of prophylactic SoC (IV antibiotic only, IV antibiotic with mechanical bowel preparation or IV antibiotic with oral antibiotics combined with mechanical bowel preparation) and by region (US versus Europe + Israel). D-PLEX will be applied during the surgery at the final stage of incision closure. All patients will be followed up for additional 5 visits over 2 months, for safety and incisional wound assessment. This will include blood tests for hematology and chemistry as well as physician's assessment of the incisional wound. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04411199
Study type Interventional
Source PolyPid Ltd.
Contact Michal Lavi
Phone +972 74-7195700
Email michal.l@polypid.com
Status Recruiting
Phase Phase 3
Start date December 6, 2020
Completion date September 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04096885 - The Inselspital Surgical Cohort Study
Terminated NCT03820648 - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy N/A
Completed NCT04067843 - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study N/A
Terminated NCT04042077 - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections Phase 3
Completed NCT05841576 - Anaesthetic Management Guided by COMET Measurements N/A
Withdrawn NCT05338281 - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Terminated NCT01789697 - Text Message Study N/A
Recruiting NCT05966961 - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Recruiting NCT05763602 - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) Phase 4
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Recruiting NCT03221023 - Intrawound Vancomycin Prophylaxis for Neural Stimulator Phase 2/Phase 3
Completed NCT03257202 - Topical Treatment and Prevalence of P. Acnes Phase 2
Completed NCT06154720 - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting NCT06465901 - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI N/A
Not yet recruiting NCT04820075 - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A