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Surgical Site InfectionPhase 3NCT04233424

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

A Phase 3 study testing D-PLEX in people with Surgical Site Infection and Colon Surgery, run by PolyPid Ltd. at 62 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
D-PLEX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
977 participants
Where
62 sitesin 10 countries
Study dates
24 Jun 2020to 2 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • 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.
  • Subjects with other concurrent severe and/or uncontrolled medical conditions.
  • Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
  • Chronic alcoholic or drug abuse subjects.
  • 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.
  • 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.
  • Subjects participating in any other interventional study.
  • 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).

Trial locations and contacts

62 sites in 10 countries.

62 sites in 10 countries

Bulgaria12 sites

  • "Multiprofile Hospital for Active Treatment - Blagoevgrad" AD

    Blagoevgrad, 2700

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

    Dupnitsa, 2600

  • "Multiprofile Hospital for Active Treatment - Haskovo" AD

    Haskovo, 6304

  • "Multiprofile Hospital for Active Treatment - Uni Hospital" OOD

    Panagyurishte, 4500

  • "MHAT Sveta Caridad" EAD

    Plovdiv, 4004

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

    Sofia, 1154

  • "IV Multiprofile Hospital for Active Treatment - Sofia" EAD

    Sofia, 1606

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

    Sofia, 1606

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

    Veliko Tarnovo, 5002

  • Complex Oncology Center - Vratsa - EOOD

    Vratsa, 3000

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

    Vratsa, 3001

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

    Yambol, 8600

Other trials in Bulgaria

Romania10 sites

  • "Sf. Constantin" Hospital

    Brasov, 500388

  • Emergency University Hospital Elias, Clinical Department of General Surgery

    Bucharest, 11461

  • Coltea Clinical Hospital, Department of General Surgery

    Bucharest, 30171

  • "Prof. Dr. Octavian Fodor"

    Cluj-Napoca, 400162

  • Medical Center Dr.Ianosi, Department of Surgery

    Craiova, 200061

  • County Emergency Clinical Hospital Craiova, Department of General Surgery III

    Craiova, 200642

  • County Emergency Clinical Hospital Craiova, Department of General Surgery II

    Craiova, 200642

  • County Emergency Clinical Hospital Craiova, Department of General Surgery I

    Craiova, 200642

  • Spitalul Clinic Judetean de Urgentã Targu-Mures

    Craiova, 200642

  • County Emergency Clinical Hospital Timisoara "Pius Brînzeu"

    Timișoara, 300723

Other trials in Romania

Hungary8 sites

  • Bajai Szent Rókus Kórház, Sebészeti Osztály

    Baja, Bács-Kiskun Megye, 6500

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Sebeszeti es Intervencios Gasztroenterologiai

    Budapest, 1082

  • Békés-Megyei Központi Kórház, I. Sebészeti Osztály

    Gyula, 5600

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

    Hódmezővásárhely, 6800

  • Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály

    Kaposvár, 7400

  • Orosházi Kórház, Invazív Mátrix Sebészet

    Orosháza, 5900

  • Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika

    Pécs, 7624

  • Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály

    Székesfehérvár, 8000

Other trials in Hungary

Israel7 sites

  • Galilee Medical Center

    Nahariya, Nahariya-Cabri, 22100

  • Rabin Medical Center

    Petah Tikva

  • The Chaim Sheba Medical Center

    Ramat Gan, Derech Sheba 2

  • Kaplan Medical Center

    Rehovot, Pasternak, 76100

  • Assuta Medical center

    Tel Aviv

  • Sourasky Medical Center

    Tel Aviv

  • Shamir (Assaf-Harofeh) Medical Center

    Zrifin

Other trials in Israel

United States5 sites

  • Summit Medical Group

    Bend, Oregon, 97701

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Paradigm Clinical Research Center

    Redding, California, 96001

  • Shoals Medical Trials

    Sheffield, Alabama, 35660

Other trials in United States

Moldova5 sites

  • IMSP Institute of Emergency Medicine

    Chisinau, 2004

  • IMSP Clinical Republican Hospital "Timofei Mosneaga"

    Chisinau, 2025

  • IMSP Institute of Oncology

    Chisinau, 2025

  • IMSP Municipal Clinical Hospital "Sfanta Treime"

    Chisinau, 2068

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

    Chisinau, MD-2001

Other trials in Moldova

Croatia4 sites

  • KBC Rijeka

    Rijeka, 51000

  • General Hospital Zadar

    Zadar, 23000

  • KBC Sestre milosrdnice Klinika za tumore

    Zagreb, 10000

  • University Hospital Centre Zagreb (KBC Rebro)

    Zagreb, 10000

Other trials in Croatia

Czechia4 sites

  • Fakultni Nemocnice Brno Chirurgicka klinika

    Brno, 62500

  • Krajska nemocnice Liberec, a. s.

    Liberec, 46001

  • Fakultni nemocnice Kralovske Vinohrady Chirurgicka klinika

    Prague, 100 34

  • Nemocnice Na Bulovce

    Prague, 18081

Other trials in Czechia

Poland4 sites

  • Oddzial Kliniczny Chirurgii Onkologicznej, Bydgoszczy

    Bydgoszcz, 85-796

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

    Krakow, 31-913

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

    Skawina, 32-050

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

    Zielona Góra, 65-046

Other trials in Poland

Slovakia3 sites

  • Vseobecna Nemocnica s Poliklinikou Lucenec Chirurgicke Oddelenie

    Lučenec, 98401

  • FNsP J.A. Reimana Presov Oddelenie chirurgie

    Prešov, 081 81

  • Fakultna nemocnica s poliklinikou Zilina Oddelenie chirurgie

    Žilina, 01001

Other trials in Slovakia

About this study

Official title: 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.

Read the 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

Being tested
D-PLEX, Standard of Care (SoC)
Keywords
Surgical site infection, Abdominal surgery, Colon and small bowl surgery
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D-PLEXDrug

    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)Drug

    prophylactic, pre-operation per institution guidelines

Study groups in NCT04233424
Study groupRoleWhat they receive
D-PLEX+SoCExperimentalD-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment
Receives: Drug: D-PLEX; Drug: Standard of Care (SoC)
Standard of careOtherThe SoC for prophylactic antibiotic treatment is based on international guidelines
Receives: Drug: Standard of Care (SoC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: By day 30 post surgery

Secondary outcomes (1)

  1. 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)].

    Measured: 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start24 Jun 2020
  3. Primary completion2 Sep 2022
  4. Study completion2 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
977 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04233424
Sponsor's protocol ID
D-PLEX 311
Status last verified
Mar 2026
First submitted
6 Jan 2020
Last updated
21 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing D-PLEX in people with Surgical Site Infection and Colon Surgery, run by PolyPid Ltd. at 62 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Bulgaria, Romania, Hungary, Israel, United States and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: By day 30 post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04233424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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