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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
975
D-PLEX is a new formulation of extended release of Doxycycline.
prophylactic, pre-operation per institution guidelines
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
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure for the primary ITT analysis.
Time frame: By day 30 post surgery
The Percentage of Subjects With at Least One SSI Event in the Target Incision
Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, occurring within 30 days post abdominal (index) surgery and determined by a blinded and independent adjudication committee. \[abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)\].
Time frame: By day 30 post surgery
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 >7 cm
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, and target incision length \> 7 cm, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure.
Time frame: 30 days post surgery
Percentage of Subjects With at Least 1 Score of ASEPSIS> 20, Within 30 Days Post Abdominal (Index) Surgery
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Augusta Univeristy
Augusta, Georgia, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Bosnia and Herzegovina
Cantonal Hospital Zenica
Zenica, Bosnia and Herzegovina
LLC American Hospital Network
Tbilisi, Georgia
LTD "Israeli - Georgian Medical Research Clinic Healthycore"
Tbilisi, Georgia
...and 48 more locations
ASEPSIS (Additional Treatment, Serous Discharge, Erythema, Purulent Exudates, Separation of Deep Tissue, Isolation of Bacteria, Stay as In Patient) is an acronym of wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection.
Time frame: 30 days post surgery