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

D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Surgery; Surgical Site Infection; Colon Surgery; Post-Op Infection
• Intervention / Treatment: Drug: D-PLEX; Drug: Standard of Care (SoC)

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 Type: Interventional
• Enrollment (Actual): 977
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • "Multiprofile Hospital for Active Treatment - Blagoevgrad" AD
  • Dupnitsa, Bulgaria, 2600
    • "Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD
  • Haskovo, Bulgaria, 6304
    • "Multiprofile Hospital for Active Treatment - Haskovo" AD
  • Panagyurishte, Bulgaria, 4500
    • "Multiprofile Hospital for Active Treatment - Uni Hospital" OOD
  • Plovdiv, Bulgaria, 4004
    • "MHAT Sveta Caridad" EAD
  • Sofia, Bulgaria, 1606
    • "IV Multiprofile Hospital for Active Treatment - Sofia" EAD
  • Sofia, Bulgaria, 1606
    • "University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD
  • Sofia, Bulgaria, 1154
    • University First Multiprofile Hospital for Active Treatment - Sofia Sv. Yoan Krastitel EAD
  • Veliko Tarnovo, Bulgaria, 5002
    • "Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD
  • Vratsa, Bulgaria, 3000
    • Complex Oncology Center - Vratsa - EOOD
  • Vratsa, Bulgaria, 3001
    • Department - Surgery, "Multiprofile Hospital for Active Treatment - Hristo Botev" AD
  • Yambol, Bulgaria, 8600
    • "Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD
• Croatia
  • Rijeka, Croatia, 51000
    • KBC Rijeka
  • Zadar, Croatia, 23000
    • General Hospital Zadar
  • Zagreb, Croatia, 10000
    • KBC Sestre milosrdnice Klinika za tumore
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb (KBC Rebro)
• Czechia
  • Brno, Czechia, 62500
    • Fakultni Nemocnice Brno Chirurgicka klinika
  • Liberec, Czechia, 46001
    • Krajská nemocnice Liberec, a. s.
  • Prague, Czechia, 18081
    • Nemocnice Na Bulovce
  • Prague, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady Chirurgicka klinika
• Hungary
  • Budapest, Hungary, 1082
    • Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Sebeszeti es Intervencios Gasztroenterologiai
  • Gyula, Hungary, 5600
    • Békés-Megyei Központi Kórház, I. Sebészeti Osztály
  • Hódmezővásárhely, Hungary, 6800
    • Csongrad-Csanad Megyei Egeszsegugyi Ellato Kozpont Hodmezovasarhely - Mako, Sebeszeti Osztaly
  • Kaposvár, Hungary, 7400
    • Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály
  • Orosháza, Hungary, 5900
    • Orosházi Kórház, Invazív Mátrix Sebészet
  • Pécs, Hungary, 7624
    • Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika
  • Székesfehérvár, Hungary, 8000
    • Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály
  • Bács-Kiskun Megye
    • Baja, Bács-Kiskun Megye, Hungary, 6500
      • Bajai Szent Rókus Kórház, Sebészeti Osztály
• Israel
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center
  • Tel Aviv, Israel
    • Assuta Medical Center
  • Zrifin, Israel
    • Shamir (Assaf-Harofeh) Medical Center
  • Derech Sheba 2
    • Ramat Gan, Derech Sheba 2, Israel
      • The Chaim Sheba Medical Center
  • Nahariya-Cabri
    • Nahariya, Nahariya-Cabri, Israel, 22100
      • Galilee Medical Center
  • Pasternak
    • Rehovot, Pasternak, Israel, 76100
      • Kaplan Medical Center
• Moldova
  • Chisinau, Moldova, 2004
    • IMSP Institute of Emergency Medicine
  • Chisinau, Moldova, 2025
    • IMSP Clinical Republican Hospital "Timofei Mosneaga"
  • Chisinau, Moldova, 2025
    • IMSP Institute of Oncology
  • Chisinau, Moldova, 2068
    • IMSP Municipal Clinical Hospital "Sfanta Treime"
  • Chisinau, Moldova, MD-2001
    • PMSI Municipal Clinical Hospital No. 1 "Gheorghe Paladi" Department of General Surgery
• Poland
  • Bydgoszcz, Poland, 85-796
    • Oddzial Kliniczny Chirurgii Onkologicznej, Bydgoszczy
  • Krakow, Poland, 31-913
    • Szpital Specjalistyczny im. Zeromskiego,Oddzial Chirurgii Ogolnej Onkologicznej i Maloinwazyjnej
  • Skawina, Poland, 32-050
    • Szpital Skawina Sp. z o.o., im. Stanley Dudricka
  • Zielona Góra, Poland, 65-046
    • Oddzial Chirurgii Ogolnej i Onkologicznej, Szpital Uniwersytecki im.Karola Marcinkowskiego
• Romania
  • Brasov, Romania, 500388
    • "Sf. Constantin" Hospital
  • Bucharest, Romania, 11461
    • Emergency University Hospital Elias, Clinical Department of General Surgery
  • Bucharest, Romania, 30171
    • Coltea Clinical Hospital, Department of General Surgery
  • Cluj-Napoca, Romania, 400162
    • "Prof. Dr. Octavian Fodor"
  • Craiova, Romania, 200061
    • Medical Center Dr.Ianosi, Department of Surgery
  • Craiova, Romania, 200642
    • County Emergency Clinical Hospital Craiova, Department of General Surgery II
  • Craiova, Romania, 200642
    • Spitalul Clinic Judetean de Urgenta Targu-Mures
  • Craiova, Romania, 200642
    • County Emergency Clinical Hospital Craiova, Department of General Surgery III
  • Craiova, Romania, 200642
    • County Emergency Clinical Hospital Craiova, Department of General Surgery I
  • Timișoara, Romania, 300723
    • County Emergency Clinical Hospital Timisoara "Pius Brînzeu"
• Slovakia
  • Lučenec, Slovakia, 98401
    • Vseobecna Nemocnica s Poliklinikou Lucenec Chirurgicke Oddelenie
  • Prešov, Slovakia, 081 81
    • FNsP J.A. Reimana Presov Oddelenie chirurgie
  • Žilina, Slovakia, 01001
    • Fakultna nemocnica s poliklinikou Zilina Oddelenie chirurgie
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Shoals Medical Trials
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Redding, California, United States, 96001
      • Paradigm Clinical Research Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Oregon
    • Bend, Oregon, United States, 97701
      • Summit Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

1. 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).
2. Subjects are preoperative hemodynamically stable
3. Male or non-pregnant female.
4. Female of child-bearing potential should have a negative pregnancy test prior to index procedure.
5. Subjects' age 18 years old and above at screening.
6. Subjects who sign the written Informed Consent Form.
7. Subjects who are willing and able to participate and meet all study requirements.
8. Survival expectancy of at least 60 days post randomization

EXCLUSION CRITERIA

1. 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.)
2. Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
3. 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.
4. Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
5. Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
6. Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
9. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
10. 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.
11. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
12. Subjects with severe hepatic impairment.
13. Subjects with chronic urticaria.
14. Subjects diagnosed with CVA within the past 6 months prior to randomization.
15. 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.
16. Any subject with an active malignancy, other than resectable non-metastatic colorectal cancer, that is the reason for the index surgery, or carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin, or a malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years.
17. Subjects with other concurrent severe and/or uncontrolled medical conditions.
18. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
19. Chronic alcoholic or drug abuse subjects.
20. Pregnant or breast-feeding women or women of child-bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period.
21. Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study.
22. Subjects participating in any other interventional study.
23. Subjects, who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-PLEX+SoC; D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment	Drug: D-PLEX; 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.; Drug: Standard of Care (SoC); prophylactic, pre-operation per institution guidelines
Other: Standard of care; The SoC for prophylactic antibiotic treatment is based on international guidelines	Drug: Standard of Care (SoC); prophylactic, pre-operation per institution guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Rate	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)].	30 days post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	All-cause mortality within 30 days post index surgery will be analysed as treatment failure.	30 day post surgery

Collaborators and Investigators

• Sponsor: PolyPid Ltd.
• Investigators: Study Director: Shmuel Sharoni, MD, PolyPid Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Surgical site infection; Abdominal surgery; Colon and small bowl surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: D-PLEX 311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No