D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Condition: Surgical Site Infection; Colon Surgery; Abdominal Surgery; Post-Op Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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 resection, with or without a stoma, that
      includes at least 1 incision that is > 10 cm (target incision). Eligible and willing subjects
      will be randomly allocated into 2 blinded study arms D-PLEX with SOC or SOC alone.

      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 well as
      physicians assessment of the incisional wound.

      The final number of subjects will be determined following a comparative interim analysis for
      an early efficacy or futility stop or unblinded sample size re-estimation: when about 750
      subjects will complete their 30 days (1 month) follow-up and evaluated for primary endpoint
    

Intervention name(s): D-PLEX; Standard of Care (SoC)
Intervention type(s): Drug; Other
Intervention description(s): 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.; prophylactic, pre-operation per institution guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Males and females, >18 years old, undergoing scheduled abdominal colon surgery involving resection and anastomosis or a stoma, who meet the inclusion criteria and none of the exclusion criteria and provide signed informed consent will be enrolled in the study.
The final number of subjects will be determined following a comparative interim analysis for an early efficacy or futility stop or unblinded sample size re-estimation: when about 750 subjects will complete their 30 days (1 month) follow-up and evaluated for primary endpoint.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Surgical site infection; Abdominal surgery; Colon and small bowl surgery