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

NCT ID: NCT04233424

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 977 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2022-09-02

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

D-PLEX+SoC

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

Group Type: EXPERIMENTAL

D-PLEX

Intervention Type: 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.

Standard of Care (SoC)

Intervention Type: DRUG

prophylactic, pre-operation per institution guidelines

Standard of care

The SoC for prophylactic antibiotic treatment is based on international guidelines

Group Type: OTHER

Standard of Care (SoC)

Intervention Type: DRUG

prophylactic, pre-operation per institution guidelines

Interventions

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.

Intervention Type: DRUG

Standard of Care (SoC)

prophylactic, pre-operation per institution guidelines

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PolyPid Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shmuel Sharoni, MD

Role: STUDY_DIRECTOR

PolyPid Ltd.

Locations

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

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 - Haskovo" AD

Haskovo, , Bulgaria

"Multiprofile Hospital for Active Treatment - Uni Hospital" OOD

Panagyurishte, , Bulgaria

"MHAT Sveta Caridad" EAD

Plovdiv, , Bulgaria

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

Sofia, , Bulgaria

"IV Multiprofile Hospital for Active Treatment - Sofia" EAD

Sofia, , 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

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

Vratsa, , Bulgaria

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

Yambol, , Bulgaria

KBC Rijeka

Rijeka, , Croatia

General Hospital Zadar

Zadar, , Croatia

KBC Sestre milosrdnice Klinika za tumore

Zagreb, , Croatia

University Hospital Centre Zagreb (KBC Rebro)

Zagreb, , Croatia

Fakultni Nemocnice Brno Chirurgicka klinika

Brno, , Czechia

Krajska nemocnice Liberec, a. s.

Liberec, , Czechia

Fakultni nemocnice Kralovske Vinohrady Chirurgicka klinika

Prague, , Czechia

Nemocnice Na Bulovce

Prague, , Czechia

Bajai Szent Rókus Kórház, Sebészeti Osztály

Baja, Bács-Kiskun Megye, Hungary

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Sebeszeti es Intervencios Gasztroenterologiai

Budapest, , Hungary

Békés-Megyei Központi Kórház, I. Sebészeti Osztály

Gyula, , Hungary

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

Hódmezővásárhely, , Hungary

Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály

Kaposvár, , Hungary

Orosházi Kórház, Invazív Mátrix Sebészet

Orosháza, , Hungary

Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika

Pécs, , Hungary

Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály

Székesfehérvár, , Hungary

The Chaim Sheba Medical Center

Ramat Gan, Derech Sheba 2, Israel

Galilee Medical Center

Nahariya, Nahariya-Cabri, Israel

Kaplan Medical Center

Rehovot, Pasternak, Israel

Rabin Medical Center

Petah Tikva, , Israel

Assuta Medical center

Tel Aviv, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

Shamir (Assaf-Harofeh) Medical Center

Zrifin, , Israel

IMSP Institute of Emergency Medicine

Chisinau, , Moldova

IMSP Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, , Moldova

IMSP Institute of Oncology

Chisinau, , Moldova

IMSP Municipal Clinical Hospital "Sfanta Treime"

Chisinau, , Moldova

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

Chisinau, , Moldova

Oddzial Kliniczny Chirurgii Onkologicznej, Bydgoszczy

Bydgoszcz, , Poland

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

Krakow, , Poland

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

Skawina, , Poland

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

Zielona Góra, , Poland

"Sf. Constantin" Hospital

Brasov, , Romania

Emergency University Hospital Elias, Clinical Department of General Surgery

Bucharest, , Romania

Coltea Clinical Hospital, Department of General Surgery

Bucharest, , Romania

"Prof. Dr. Octavian Fodor"

Cluj-Napoca, , Romania

Medical Center Dr.Ianosi, Department of Surgery

Craiova, , Romania

County Emergency Clinical Hospital Craiova, Department of General Surgery III

Craiova, , Romania

County Emergency Clinical Hospital Craiova, Department of General Surgery II

Craiova, , Romania

County Emergency Clinical Hospital Craiova, Department of General Surgery I

Craiova, , Romania

Spitalul Clinic Judetean de Urgentã Targu-Mures

Craiova, , Romania

County Emergency Clinical Hospital Timisoara "Pius Brînzeu"

Timișoara, , Romania

Vseobecna Nemocnica s Poliklinikou Lucenec Chirurgicke Oddelenie

Lučenec, , Slovakia

FNsP J.A. Reimana Presov Oddelenie chirurgie

Prešov, , Slovakia

Fakultna nemocnica s poliklinikou Zilina Oddelenie chirurgie

Žilina, , Slovakia

Countries

United States; Bulgaria; Croatia; Czechia; Hungary; Israel; Moldova; Poland; Romania; Slovakia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

D-PLEX 311

Identifier Type: -

Identifier Source: org_study_id