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

NCT04233424 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: D-PLEX 311
• Study Type: interventional
• Target: 977
• Locations: 10 countries
• Sites: 62

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.

Conditions

Surgical Site Infection; Colon Surgery; Abdominal Surgery; Post-Op Infection

Keywords

Surgical site infection; Abdominal surgery; Colon and small bowl surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  By day 30 post surgery

Secondary Outcomes (1)

• Infection Rate

  30 days post-surgery

Other Outcomes (1)

• All-cause Mortality

  30 day post surgery

Study Arms (2)

D-PLEX+SoC

EXPERIMENTAL

D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment

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

Standard of care

OTHER

The SoC for prophylactic antibiotic treatment is based on international guidelines

Drug: Standard of Care (SoC)

Interventions

D-PLEX DRUG

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.

D-PLEX+SoC

Standard of Care (SoC) DRUG

prophylactic, pre-operation per institution guidelines

D-PLEX+SoC; Standard of care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is \> 10cm (target incision).
• Subjects are preoperative hemodynamically stable
• Male or non-pregnant female.
• Female of child-bearing potential should have a negative pregnancy test prior to index procedure.
• Subjects' age 18 years old and above at screening.
• Subjects who sign the written Informed Consent Form.
• Subjects who are willing and able to participate and meet all study requirements.
• Survival expectancy of at least 60 days post randomization

You may not qualify if:

• Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis, volvulus, ect.)
• Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
• Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre-operative prophylaxis.
• Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
• Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
• Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
• Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
• Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
• Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
• Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions.
• Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
• Subjects with severe hepatic impairment.
• Subjects with chronic urticaria.
• Subjects diagnosed with CVA within the past 6 months prior to randomization.
• Subjects who underwent any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years.

Sponsors & Collaborators

• PolyPid Ltd.: lead

Study Sites (62)

Shoals Medical Trials

Sheffield, Alabama, 35660, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Paradigm Clinical Research Center

Redding, California, 96001, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Summit Medical Group

Bend, Oregon, 97701, United States

Location

"Multiprofile Hospital for Active Treatment - Blagoevgrad" AD

Blagoevgrad, 2700, Bulgaria

Location

"Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD

Dupnitsa, 2600, Bulgaria

Location

"Multiprofile Hospital for Active Treatment - Haskovo" AD

Haskovo, 6304, Bulgaria

Location

"Multiprofile Hospital for Active Treatment - Uni Hospital" OOD

Panagyurishte, 4500, Bulgaria

Location

"MHAT Sveta Caridad" EAD

Plovdiv, 4004, Bulgaria

Location

University First Multiprofile Hospital for Active Treatment - Sofia Sv. Yoan Krastitel EAD

Sofia, 1154, Bulgaria

Location

"IV Multiprofile Hospital for Active Treatment - Sofia" EAD

Sofia, 1606, Bulgaria

Location

"University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD

Sofia, 1606, Bulgaria

Location

"Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD

Veliko Tarnovo, 5002, Bulgaria

Location

Complex Oncology Center - Vratsa - EOOD

Vratsa, 3000, Bulgaria

Location

Department - Surgery, "Multiprofile Hospital for Active Treatment - Hristo Botev" AD

Vratsa, 3001, Bulgaria

Location

"Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD

Yambol, 8600, Bulgaria

Location

KBC Rijeka

Rijeka, 51000, Croatia

Location

General Hospital Zadar

Zadar, 23000, Croatia

Location

KBC Sestre milosrdnice Klinika za tumore

Zagreb, 10000, Croatia

Location

University Hospital Centre Zagreb (KBC Rebro)

Zagreb, 10000, Croatia

Location

Fakultni Nemocnice Brno Chirurgicka klinika

Brno, 62500, Czechia

Location

Krajska nemocnice Liberec, a. s.

Liberec, 46001, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady Chirurgicka klinika

Prague, 100 34, Czechia

Location

Nemocnice Na Bulovce

Prague, 18081, Czechia

Location

Bajai Szent Rókus Kórház, Sebészeti Osztály

Baja, Bács-Kiskun Megye, 6500, Hungary

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Sebeszeti es Intervencios Gasztroenterologiai

Budapest, 1082, Hungary

Location

Békés-Megyei Központi Kórház, I. Sebészeti Osztály

Gyula, 5600, Hungary

Location

Csongrad-Csanad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely - Mako, Sebeszeti Osztaly

Hódmezővásárhely, 6800, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály

Kaposvár, 7400, Hungary

Location

Orosházi Kórház, Invazív Mátrix Sebészet

Orosháza, 5900, Hungary

Location

Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika

Pécs, 7624, Hungary

Location

Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály

Székesfehérvár, 8000, Hungary

Location

The Chaim Sheba Medical Center

Ramat Gan, Derech Sheba 2, Israel

Location

Galilee Medical Center

Nahariya, Nahariya-Cabri, 22100, Israel

Location

Kaplan Medical Center

Rehovot, Pasternak, 76100, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Assuta Medical center

Tel Aviv, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Shamir (Assaf-Harofeh) Medical Center

Zrifin, Israel

Location

IMSP Institute of Emergency Medicine

Chisinau, 2004, Moldova

Location

IMSP Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, 2025, Moldova

Location

IMSP Institute of Oncology

Chisinau, 2025, Moldova

Location

IMSP Municipal Clinical Hospital "Sfanta Treime"

Chisinau, 2068, Moldova

Location

PMSI Municipal Clinical Hospital No. 1 "Gheorghe Paladi" Department of General Surgery

Chisinau, MD-2001, Moldova

Location

Oddzial Kliniczny Chirurgii Onkologicznej, Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Szpital Specjalistyczny im. Zeromskiego,Oddzial Chirurgii Ogolnej Onkologicznej i Maloinwazyjnej

Krakow, 31-913, Poland

Location

Szpital Skawina Sp. z o.o., im. Stanley Dudricka

Skawina, 32-050, Poland

Location

Oddzial Chirurgii Ogolnej i Onkologicznej, Szpital Uniwersytecki im.Karola Marcinkowskiego

Zielona Góra, 65-046, Poland

Location

"Sf. Constantin" Hospital

Brasov, 500388, Romania

Location

Emergency University Hospital Elias, Clinical Department of General Surgery

Bucharest, 11461, Romania

Location

Coltea Clinical Hospital, Department of General Surgery

Bucharest, 30171, Romania

Location

"Prof. Dr. Octavian Fodor"

Cluj-Napoca, 400162, Romania

Location

Medical Center Dr.Ianosi, Department of Surgery

Craiova, 200061, Romania

Location

County Emergency Clinical Hospital Craiova, Department of General Surgery III

Craiova, 200642, Romania

Location

County Emergency Clinical Hospital Craiova, Department of General Surgery II

Craiova, 200642, Romania

Location

County Emergency Clinical Hospital Craiova, Department of General Surgery I

Craiova, 200642, Romania

Location

Spitalul Clinic Judetean de Urgentã Targu-Mures

Craiova, 200642, Romania

Location

County Emergency Clinical Hospital Timisoara "Pius Brînzeu"

Timișoara, 300723, Romania

Location

Vseobecna Nemocnica s Poliklinikou Lucenec Chirurgicke Oddelenie

Lučenec, 98401, Slovakia

Location

FNsP J.A. Reimana Presov Oddelenie chirurgie

Prešov, 081 81, Slovakia

Location

Fakultna nemocnica s poliklinikou Zilina Oddelenie chirurgie

Žilina, 01001, Slovakia

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Eyal Shoshani, VP Clinical Affairs
• Organization: PolyPid

eyal.s@polypid.com

+972-74-7195700

Study Officials

• Shmuel Sharoni, MD

  PolyPid Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind clinical trial. The sponsor, the subjects, outcomes assessor and all staff involved in the collection and recording of the clinical and laboratory data, based on which the independent adjudication committee will perform their assessment, will be blind to treatment assignment. In addition, all aspects of data management and clean-up will be done in blinded datasets. The study site personnel, who perform the index surgery (Operation room staff), will be trained not to disclose the treatment arm to the blinded Investigator, to the subject, his/her family, to other health care providers not present during the surgery or to the study Sponsor representatives. Wound assessment throughout the study follow-up visits will be done by a blinded Investigator, that will not be involved in the surgery. An emergency card containing the Study Name, NIH number, Center Name/number, PI's name and contact details will be provided to the subjects.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: June 24, 2020
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: April 21, 2026
• Results First Posted: June 22, 2025

Record last verified: 2026-03

Locations

MO (5); CZ (4); IL (7); HU (8); US (5); SL (3); RO (10); BU (12); CR (4); PL (4)