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
• Interventions: Other: Standard of Care (SoC); Drug: D-PLEX

• Registration Number: NCT04233424
• Lead Sponsor: PolyPid Ltd.

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

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-18
• Study Start: 2020-06-24
• Status Verified: 2022-05
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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. \[abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\].

Secondary Outcome Measures

Name	Time	Method
Assessment of Infection rate in patient undergoing abdominal colon surgery	At study visits: day 1, day 5, day 14 and 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.; \[abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\].

Trial Locations

Locations (59)

Shoals Medical Trials; 🇺🇸 Sheffield, Alabama, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

"Multiprofile Hospital for Active Treatment - Haskovo" AD; 🇧🇬 Haskovo, Bulgaria

Békés-Megyei Központi Kórház, I. Sebészeti Osztály; 🇭🇺 Gyula, Hungary

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia

Paradigm Clinical Research Center; 🇺🇸 Redding, California, United States

"Multiprofile Hospital for Active Treatment - Blagoevgrad" AD; 🇧🇬 Blagoevgrad, Bulgaria

Summit Medical Group; 🇺🇸 Bend, Oregon, United States

Siteman Cancer Center - South County; 🇺🇸 Saint Louis, Missouri, United States

"Multiprofile Hospital for Active Treatment - Uni Hospital" OOD; 🇧🇬 Panagyurishte, Bulgaria

"MHAT "Rahila Angelova"" AD; 🇧🇬 Pernik, 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

University First Multiprofile Hospital for Active Treatment - Sofia; 🇧🇬 Sofia, Bulgaria

"MHAT Sveta Caridad" EAD; 🇧🇬 Plovdiv, Bulgaria

"IV Multiprofile Hospital for Active Treatment - Sofia" EAD; 🇧🇬 Sofia, Bulgaria

"Multiprofile hospital for active treatment - Plovdiv" AD; 🇧🇬 Plovdiv, Bulgaria

"University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD; 🇧🇬 Sofia, Bulgaria

"Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD; 🇧🇬 Veliko Tarnovo, Bulgaria

Complex Oncology Center - Vratsa - EOOD; 🇧🇬 Vratsa, Bulgaria

Multiprofile Hospital for Active Treatment; 🇧🇬 Vratsa, Bulgaria

General Hospital Zadar; 🇭🇷 Zadar, Croatia

Fakultní Nemocnice Brno; 🇨🇿 Brno, Czechia

KBC Rijeka; 🇭🇷 Rijeka, Croatia

"Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD; 🇧🇬 Yambol, Bulgaria

Krajská nemocnice Liberec; 🇨🇿 Liberec, Czechia

KBC Sestre milosrdnice; 🇭🇷 Zagreb, Croatia

Nemocnice Na Bulovce; 🇨🇿 Prague, Czechia

Fakultní Nemocnice Královské Vinohrady; 🇨🇿 Prague, Czechia

Ustredni Vojenska Nemocnice Praha; 🇨🇿 Praha, Czechia

Bajai Szent Rókus Kórház, Sebészeti Osztály; 🇭🇺 Baja, Bács-Kiskun Megye, Hungary

Csongrád-Csanád Megyei Egészségügyi Ellátó Központ Hódmezővásárhely - Makó; 🇭🇺 Hódmezővásárhely, Hungary

Orosházi Kórház, Invazív Mátrix Sebészet; 🇭🇺 Orosháza, Hungary

Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály; 🇭🇺 Kaposvár, Hungary

Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika; 🇭🇺 Pécs, Hungary

Sheba Medical Center; 🇮🇱 Ramat Gan, Derech Sheba 2, Israel

Shamir Medical Center; 🇮🇱 Zrifin, Israel

West Galilee medical Center; 🇮🇱 Nahariya, Nahariya-Cabri, Israel

Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály; 🇭🇺 Székesfehérvár, Hungary

Kaplan Medical Center; 🇮🇱 Reẖovot, Pasternak Saint, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

IMSP Institut of Emmergency Medicine; 🇲🇩 Chisinau, Moldova, Republic of

Rabin Medical Center; 🇮🇱 Pethah Tiqvā, Israel

Assuta Medical center; 🇮🇱 Tel Aviv, Israel

IMSP Clinical republican Hospital "Timofei Mosneaga"; 🇲🇩 Chisinau, Moldova, Republic of

IMSP Intitute of Oncology; 🇲🇩 Chisinau, Moldova, Republic of

IMSP Municipal Clinical Hospital "Sfanta Treime"; 🇲🇩 Chisinau, Moldova, Republic of

"Sf. Constantin" Hospital; 🇷🇴 Brasov, Romania

Emergency University Hospital Elias, Clinical Department of General Surgery; 🇷🇴 Bucharest, Romania

Clinical County Hospital Cluj Napoca; 🇷🇴 Cluj-Napoca, Romania

"Prof. Dr. Octavian Fodor"; 🇷🇴 Cluj-Napoca, Romania

County Emergency Clinical Hospital Craiova, Department of General Surgery II; 🇷🇴 Craiova, Romania

Spitalul Clinic Judetean de Urgentã Targu-Mures; 🇷🇴 Craiova, Romania

Coltea Clinical Hospital; 🇷🇴 Bucharest, Romania

Pelican Hospital Oradea; 🇷🇴 Oradea, Romania

County Emergency Clinical Hospital Timisoara "Pius Brînzeu"; 🇷🇴 Timisoara, Romania

Medical Center Dr.Ianosi, Department of Surgery; 🇷🇴 Craiova, Romania

Spitalul Clinic Judetean de Urgentã Craiova; 🇷🇴 Craiova, Romania