Surgical Site InfectionPhase 3D-PLEX312NCT04411199
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
A Phase 3 study testing D-PLEX in people with Surgical Site Infection and Colon Surgery, run by PolyPid Ltd. at 58 sites in 13 countries.
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
- Conditions the study is for
- Surgical Site Infection, Colon Surgery, Abdominal Surgery
- What is being tested?
- D-PLEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 58 sitesin 13 countries
- Study dates
- 15 Dec 2020to 10 May 2025
- Phase
- Phase 3
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 >20cm (target incision).
- Subjects are preoperative hemodynamically stable. (BP≤180/110 and >90/60 mmHg, and HR≤120 and >60 bpm, and temperature ≤37.50C and >35.50C).
- Male or non-pregnant female.
- Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) 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 sixty 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, etc.)
- Subjects who underwent an intra-abdominal surgery within the last six months prior to randomization.
- Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past one week prior to randomization, excluding pre-operative prophylaxis or antibiotics for the treatment of the disease that is the indication for surgery.
- Subjects undergoing concomitant major procedures in addition to the colorectal resection. Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor.
- Subjects who received any anti-cancer treatment within the last four weeks of surgery.
- Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, within the last four weeks of the planned abdominal surgery.
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- Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past four 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 three substances.
- 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.
- Uncontrolled medical condition.
- 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 three years.
- Any subject with an active malignancy or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least three years.
Trial locations and contacts
58 sites in 13 countries.
58 sites in 13 countries
Hungary9 sites
Bajai Szent Rokus Korhaz, Sebeszeti Osztaly
Baja, 6500
Uzsoki Utcai Kórház, Sebészeti Osztály
Budapest, 1145
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet Sebeszeti es Ersebeszeti osztaly
Eger, 3300
Bugát Pál Kórház, Gasztroenterológia - Sebészet
Gyöngyös, 3200
Bács-Kiskun Megyei Kórház
Kecskemét, 6000
Pest Megyei Flór Ferenc Kórház Sebészeti Osztály
Kistarcsa, 2143
Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Sebeszeti Osztaly
Nyíregyháza, 4400
University of Szeged, Faculty of Medicine, Dep.of Surgery
Szeged, 6725
Fejer-County Saint George University Teaching Hospital, Department of Surgery
Székesfehérvár, 8000
Israel8 sites
Soroka Medical Center
Beersheba, 8457108
Bnai Zion Medical Center
Haifa, 3339419
Carmel Medical Center
Haifa, 3436212
Shaare Zedek Medical Center
Jerusalem, 9372212
Galilee Medical Center
Nahariya, 2210001
Sheba Medical Center
Ramat Gan, 5262000
Kaplan Medical Center
Rehovot, 7661041
Assaf Harofeh Medical Center
Ẕerifin, 70300
Moldova6 sites
IMSP Institutul de Medicina Urgenta
Chisinau, MD2004
IMSP Clinical republican Hospital "Timofei Mosneaga"
Chisinau, MD2025
IMSP Institutul of Oncologic
Chisinau, MD2025
IMSP Spitalul Clinic Republican "Timofei Mosneaga"
Chisinau, MD2025
IMSP Spitalul Clinic Municipal "Gheorghe Paladi"
Chisinau, MD2038
IMSP Spitalul Clinic Municipal "Sfanta Treime"
Chisinau, MD2068
United States5 sites
Augusta Univeristy
Augusta, Georgia, 30912
Baylor University Medical Center
Dallas, Texas, 75246
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Ochsner Medical Center
New Orleans, Louisiana, 70121
Washington University School of Medicine
St Louis, Missouri, 63110
North Macedonia5 sites
PHI General Hospital "Borka Taleski" Prilep
Prilep, 7500
PHI University Clinic for digestive Surgery
Skopje, 1000
PHI University Clinic for Surgical Diseases "st.Naum Ohridski - Skopje"
Skopje, 1000
PHI Clinical Hospital - Shtip
Skopje, 2000
PHI General Hospital - Strumica
Strumica, 2400
Romania5 sites
Sf. Constantin Hospital
Brasov, 500388
Spitalul Clinic Judetean de Urgenta Craiova, Sectia Cbirurgie Generala II
Craiova, 200642
Spitalul Clinic Judetean de Urgenta Craiova, Sectia Chirurgie Generala III
Craiova, 200642
Mures County Clinical Hospital
Târgu Mureş, 540103
Spitalul Clinic JudeIean de Urgenta "Pius Brinzeu", Sectia Chirurgie Generala II
Timișoara, 300723
Serbia5 sites
First Surgical Clinic
Belgrade, 11000
Oncology Institute of Vojvodina
Kamenitz, 21204
UCC Nis
Niš, 18000
General Hospital Sremska Mitrovica
Sremska Mitrovica, 22000
Health Center Valjevo
Valjevo, 14000
Georgia4 sites
LLC American Hospital Network
Tbilisi, 0102
LTD "Israeli - Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
LTD New Hospitals
Tbilisi, 0114
LTD Multiprofile Clinic Consillium Medulla
Tbilisi, 0186
Bosnia and Herzegovina3 sites
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000
University Clinical Center Tuzla
Tuzla, 75000
Cantonal Hospital Zenica
Zenica, 72000
Portugal3 sites
Unidade Local de Saúde da Região de Aveiro E. P. E.
Aveiro, 3810-164
Centro Clinico Academico de Braga Associação - Hospital de Braga
Braga, 4710-243
Unidade de Saúde Local da Guarda
Guarda, 6300-749
Germany2 sites
University Hospital Erlangen
Erlangen, 91054
University of Muenster
Münster, 48149
Poland2 sites
Centrum Medyczne Med-Gastr
Lodz, 91-034
Szpital Powiatowy im. Marii Skłodowskiej - Curie w Ostrowie Mazowieckiej SPZZOZ
Ostrów Mazowiecka, 07-300
About this study
Official title: D-PLEX 312 - 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 II)
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 colon or rectal resection, with or without a stoma formation, that includes at least 1 incision that is > 20cm (target incision).
Eligible and willing subjects will be randomly allocated into 2 blinded study arms, either to the investigational arm (D-PLEX + SoC) or to the control arm (SoC only) in a 1:1 ratio. Subjects will be stratified by type of prophylactic SoC (IV antibiotic only, IV antibiotic with mechanical bowel preparation or IV antibiotic with oral antibiotics combined with mechanical bowel preparation) and by region (US versus Europe + Israel).
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 as well as physician's assessment of the incisional wound.
- 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.
Standard of Care (SoC)Other
prophylactic, pre-operation per institution guidelines
| Study group | Role | What they receive |
|---|---|---|
| D-PLEX+SoC | Experimental | D-PLEX is provided as an adjunct to the SoC treatment Receives: Drug: D-PLEX; Other: Standard of Care (SoC) |
| Standard of Care | Other | The SoC for prophylactic antibiotic treatment is based on international guidelines Receives: Other: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >20 cm
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure for the primary ITT analysis.
Measured: By day 30 post surgery
Secondary outcomes (3)
The Percentage of Subjects With at Least One SSI Event in the Target Incision
Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, occurring within 30 days post abdominal (index) surgery and determined by a blinded and independent adjudication committee. [abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)].
Measured: By day 30 post surgery
Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >7 cm
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, and target incision length > 7 cm, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure.
Measured: 30 days post surgery
Percentage of Subjects With at Least 1 Score of ASEPSIS> 20, Within 30 Days Post Abdominal (Index) Surgery
ASEPSIS (Additional Treatment, Serous Discharge, Erythema, Purulent Exudates, Separation of Deep Tissue, Isolation of Bacteria, Stay as In Patient) is an acronym of wound assessment and treatment parameters, which provides numerically score during an inspection of the surgical site. The final score is being interpreted to severity of wound appearance and the clinical consequences of the infection.
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.
- First posted2 Jun 2020
- Study start15 Dec 2020
- Primary completion14 Apr 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyPid Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411199
- Sponsor's protocol ID
- D-PLEX 312
- Acronym
- D-PLEX312
- Status last verified
- Jun 2026
- First submitted
- 27 May 2020
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No