Abdominal Surgery Clinical Trial
Official title:
Phase II, Multicentre, Randomized, Controlled, Two Arm, Single Blind Study to Assess Safety and Efficacy of D-PLEX Administered Concomitantly With SOC, Compared to SOC, in Prevention of Post Abdominal Surgery Incisional Infection.
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study
entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered
concomitantly with the standard of care (SOC). The other half will receive the Standard of
Care treatment.
Following the surgery subjects will be followed up for additional 5 visits, at least half are
in line with the routine practice of surgery Follow-Ups.
Visits will include patient safety and wound assessments.
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.
Eligible and willing subjects will be randomly divided, in a single-blinded manor into 2
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, chemistry and PK (for some only) as well as physicians assessment of the
incisional wound.
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