D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

Phase 3

Completed

Conditions: Surgical Site Infection
Colon Surgery
Post-Op Infection
Abdominal Surgery

Brief 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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of Care (SoC)	The SoC for prophylactic antibiotic treatment is based on international guidelines
D-PLEX+SoC	D-PLEX	D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment

Primary Outcome Measures

Name	Time	Method
To Assess the Anti-infective Efficacy of D-PLEX Over a Period of 30 Days Post Operation, by Preventing Surgical Site Infection (SSI), Defined as Superficial and Deep Infection, in the Target Incision(s), Compared to the SoC Treated Control.	By day 30 post surgery	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. \[Abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\]. The blinded and independent adjudication committee review will include all index surgery incisions, regardless of any re-intervention at the target site, for the determination of infection status. The committee will also assess re-interventions at the primary incision site through the abdominal incision (target) for the determination of re-intervention due to suspected SSI or due to poor wound healing, including wound dehiscence. Such events, as well as all-cause mortality within 30 days post-index surgery will be analyzed as treatment failure.

Secondary Outcome Measures

Name	Time	Method
Assessment of Infection Rate in Patient Undergoing Abdominal Colon Surgery	30 days post-surgery	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. \[abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\].

Locations (59): Shoals Medical Trials
🇺🇸
Sheffield, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Paradigm Clinical Research Center
🇺🇸
Redding, California, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Siteman Cancer Center - South County
🇺🇸
Saint Louis, Missouri, United States
Summit Medical Group
🇺🇸
Bend, Oregon, United States
"Multiprofile Hospital for Active Treatment - Blagoevgrad" AD
🇧🇬
Blagoevgrad, Bulgaria
"Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD
🇧🇬
Dupnitsa, Bulgaria
"Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oryahovitsa" EOOD
🇧🇬
Gorna Oryahovitsa, Bulgaria
"Multiprofile Hospital for Active Treatment - Haskovo" AD
🇧🇬
Haskovo, Bulgaria
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Shoals Medical Trials
🇺🇸Sheffield, Alabama, United States