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    Summary
    EudraCT Number:2020-003617-36
    Sponsor's Protocol Code Number:D-PLEX312
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003617-36
    A.3Full title of the trial
    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.
    Studio di fase III, prospettico, multinazionale, multicentrico, randomizzato, controllato, a due bracci, in doppio cieco per valutare l'efficacia e la sicurezza di D-PLEX somministrato in concomitanza con lo standard di cura (SoC) rispetto a un braccio di controllo trattato con SoC nella prevenzione dell'infezione incisionale post-operatoria.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of D-PLEX in prevention of infections following abdominal surgeries.
    Studio di D-PLEX nella prevenzione delle infezioni a seguito di interventi chirurgici addominali.
    A.3.2Name or abbreviated title of the trial where available
    Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection.
    D-PLEX-312
    A.4.1Sponsor's protocol code numberD-PLEX312
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04411199
    A.5.4Other Identifiers
    Name:NANumber:NA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPolyPid Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPolyPid Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPolyPid Ltd.
    B.5.2Functional name of contact pointVP Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressHasivim 18
    B.5.3.2Town/ cityPetach Tikva
    B.5.3.3Post code4959376
    B.5.3.4CountryIsrael
    B.5.4Telephone number00972747195700
    B.5.5Fax number00972747195718
    B.5.6E-mailDalit.H@polypid.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameD-PLEX
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder and solvent for implantation paste
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXYCYCLINE HYCLATE
    D.3.9.1CAS number 24390-14-5
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB01830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of post abdominal surgery incisional infection.
    Prevenzione dell'infezione incisionale post chirurgia addominale.
    E.1.1.1Medical condition in easily understood language
    Prevention of post abdominal surgery incisional infection
    Prevenzione dell'infezione incisionale post chirurgia addominale
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10078408
    E.1.2Term Surgical site infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the anti-infective efficacy of D-PLEX administered concomitantly with the Standard of Care (SoC) over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and/or deep infection, in the target incision, compared to the SoC treated control arm and to assess the safety of D-PLEX administered concomitantly with the Standard of Care (SoC).
    Valutare l'efficacia antinfettiva di D-PLEX somministrato in concomitanza con lo standard di cura (SoC, Standard of Care) per un periodo di 30 giorni dall'intervento, prevenendo l'infezione del sito chirurgico (SSI), definita come infezione superficiale e/o profonda dell'incisione target rispetto al braccio di controllo trattato con SoC e per valutare la sicurezza di D-PLEX somministrato in concomitanza con lo Standard of Care (SoC).
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects undergoing a colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 incision that is = 7cm (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 (serum or urine dipstick) prior to index procedure.
    Note: All female subjects of child-bearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study.
    5. Subjects' age 18 years old and above at screening.
    6. Subjects who sign a 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.
    1. Soggetti sottoposti a chirurgia del colon-retto con resezione, con o senza formazione di stoma, che comprende almeno 1 incisione =7 cm (incisione target).
    2. I soggetti devono essere stabili dal punto di vista emodinamico prima dell'intervento.
    3. Soggetti di sesso maschile o femminile non in gravidanza.
    4. Le donne in età fertile devono presentare un test di gravidanza negativo (mediante test sierico o delle urine) prima della procedura indice.
    Nota: tutti i soggetti di sesso femminile in età fertile devono accettare di utilizzare un metodo contraccettivo altamente efficace in modo corretto per tutta la durata dello studio.
    5. Soggetti con età pari o superiore a 18 anni allo screening.
    6. Soggetti che firmano un modulo di consenso informato scritto.
    7. Soggetti disposti e in grado di partecipare allo studio e che soddisfano tutti i requisiti dello studio.
    8. Aspettativa di sopravvivenza di almeno 60 giorni dopo la randomizzazione.
    E.4Principal exclusion criteria
    1. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization besides pre-operative prophylaxis or antibiotic for the treatment of the disease that consists the indication for surgery.
    2. Subjects undergoing concomitant additional major procedures besides abdominal surgery. 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.
    3. Subject received anti-cancer treatment within the last 4 weeks of surgery, or radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
    4. Subjects that received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 weeks prior to randomization.
    5. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
    6. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled in during the screening process).
    7. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or in the opinion of the Investigator the subject is at high risk of developing severe allergic reactions.
    8. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
    9. Subjects with chronic urticaria.
    10. Subjects diagnosed with CVA within the past 6 months prior to randomization.
    11. Subjects who underwent any abdominal surgery and current planned surgery involves re-opening the scar of a prior abdominal surgery performed within the last 5 years.
    12. Any subject with active malignancy or with malignancy that has not been in remission for at least 3 years. Excluding:
    -Subjects with potentially resectable non-metastatic cancer which consists of the indication for the surgery.
    -Subjects who have had carcinoma in situ (or other cancer "in situ = Stage 0"), squamous cell carcinoma of the skin and basal cell carcinoma of the skin.
    -Subjects with any additional non-violent cancer (slowly growing, localized or chronic cancers, that does not require immediate intervention or chemo- or immunotherapy 4 weeks prior to the surgery, and throughout the entire study duration.
    13. Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study.
    14. Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
    15. Chronic alcoholic or drug abuse subjects.
    16. Pregnant or breast-feeding women or women of childbearing age who refuse or prohibited of using an effective contraceptive method of birth control throughout study participation, including safety follow-up period.
    17. Subjects that received any investigational drug within 30 days or 5 half-lives of randomization to the study (whichever is longer).
    18. Subjects participating in any other interventional studies.
    19. In the opinion of Investigator, the subject is not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).
    1. Soggetti con qualsiasi infezione attiva pre-operatoria o sottoposti a terapia antibiotica nell'ultima settimana precedente alla randomizzazione o antibiotici prima della randomizzazione, oltre alla profilassi pre-operatoria o agli antibiotici per il trattamento della malattia che è alla base della necessità dell'intervento chirurgico.
    2. Soggetti sottoposti ad altre procedure rilevanti e concomitanti oltre all'intervento chirurgico addominale. Intervento chirurgico di sterilizzazione femminile (ad es., salpingo-ooforectomia ecc.); può essere ammesso l'esecuzione di una procedura dell'intestino tenue o colecistectomia, in attesa di un consulto specialistico e dell'approvazione dello Sponsor.
    3. Soggetto che ha ricevuto un trattamento antitumorale nelle ultime 4 settimane dall'intervento chirurgico, o radioterapia dovuta a tumore del colon-retto nell'area dell'addome prima dell'intervento chirurgico programmato.
    4. Soggetti che hanno ricevuto antibiotici della famiglia delle doxicicline o delle tetracicline somministrati per via orale o endovenosa nelle 4 settimane precedenti alla randomizzazione.
    5. Soggetti con allergia nota alla famiglia di farmaci delle doxicicline e/o delle tetracicline o agli eccipienti di D-PLEX.
    6. Soggetti con allergie note a più di 3 sostanze (un questionario allergologico verrà compilato durante il processo di screening).
    7. Soggetti con anamnesi di gravi reazioni allergiche a qualsiasi sostanza, che hanno ricevuto trattamento con steroidi per via endovenosa/epinefrina per via intramuscolare o che siano, secondo il parere dello sperimentatore, a rischio elevato di sviluppare reazioni allergiche gravi.
    8. Soggetti con malattia renale allo stadio terminale (ESRD/CKD fase 5).
    9. Soggetti con orticaria cronica.
    10. Soggetti con diagnosi di CVA negli ultimi 6 mesi prima della randomizzazione.
    11. I soggetti sottoposti a chirurgia addominale e per i quali è attualmente programmato un intervento chirurgico che comporta la riapertura di una cicatrice relativa a un intervento addominale eseguito negli ultimi 5 anni.
    12. Qualsiasi soggetto affetto da neoplasia maligna attiva o con neoplasia maligna non in remissione da almeno 3 anni. Sono esclusi:
    • Soggetti con tumore non metastatico potenzialmente resecabile, che costituisce l'indicazione per l'intervento chirurgico.
    • Soggetti con carcinoma in situ (o altri tumori "in situ = stadio 0"), carcinoma a cellule squamose della cute e carcinoma basocellulare della cute.
    • Soggetti con qualsiasi ulteriore cancro non aggressivo (crescita lenta, tumori localizzati o cronici, tumori che non richiedono un intervento immediato o chemio-immunoterapia 4 settimane prima dell'intervento chirurgico e per tutta la durata dello studio).
    13. Soggetti con altre condizioni mediche gravi e/o non controllate che potrebbero compromettere la partecipazione allo studio.
    14. Disturbo psichiatrico o qualsiasi altro disturbo che compromette la capacità di fornire il consenso informato per la partecipazione a questo studio.
    15. Soggetti con abuso cronico di alcol o sostanze stupefacenti.
    16. Donne in gravidanza o che allattano al seno o donne in età fertile che rifiutano o non fanno uso di un metodo contraccettivo efficace durante l'intera partecipazione allo studio, compreso il periodo di follow-up di sicurezza.
    17. Soggetti che hanno ricevuto un qualsiasi farmaco sperimentale entro 30 giorni o 5 emivite dalla randomizzazione allo studio (a seconda di quale sia il termine più lungo).
    18. Soggetti che partecipano a qualsiasi altro studio interventistico.
    19. Secondo lo sperimentatore, il soggetto non è idoneo a partecipare allo studio e/o a rispettare i requisiti del protocollo (ad esempio a causa di una condizione cognitiva o medica).
    E.5 End points
    E.5.1Primary end point(s)
    Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event, occurred within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee. [Abdominal incisional infection is composed defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)].
    All cause mortality and new target incision surgery within 30 days of index surgery will be analyzed as treatment failure. An independent blinded judging committee will review each suspected case of SSI and judge whether it meets the SSI endpoint criteria.
    Tasso di infezioni misurato in base alla percentuale di soggetti con almeno un evento di infezione incisionale addominale, verificato entro 30 giorni dopo l'intervento chirurgico addominale, in base a quanto determinato da un comitato giudicante in cieco e indipendente. [L'infezione dell'incisione addominale è definita come infezione profonda dell'incisione chirurgica (DSSI) e/o infezione superficiale dell'incisione chirurgica (SSSI)].
    La mortalità da qualsiasi causa e i nuovi interventi relativi all'incisione target entro 30 giorni dall'intervento chirurgico indice verranno analizzati come fallimento del trattamento. Un comitato giudicante indipendente e in cieco esaminerà ogni caso sospetto di SSI e giudicherà se è conforme ai criteri dell'endpoint SSI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 giorni
    E.5.2Secondary end point(s)
    Key endpoints:
    - Infection rate as measured by the proportion of subjects with at least one abdominal target incisional infection event only, occurred within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee.
    - Number (percent) of subjects with at least 1 score of ASEPSIS > 20, within 30 days post abdominal surgery.
    Additional endpoints:
    - Incidence of SSSI during 30 days post index surgery.
    - Incidence of DSSI during 30 days post index surgery.
    - All-cause mortality rate within 30 days post randomization.
    - All-cause mortality rate within 60 days post randomization.
    - Time to adjudicated SSI during 30 days post index surgery.
    - Number (percent) of subjects re-admitted during 30 days post-surgery (for any reason) that have experienced adjudicated SSI during this re-admission.
    - Number (percent) of subjects who experienced at least 1 surgical re-intervention due to adjudicated SSIs during 30 days post-surgery.
    SSI related Additional Endpoints:
    - Number (percent) of subjects with adjudicated SSI where at least one Doxycycline-resistant bacteria have grown in bacteriological tests.
    - Number (percent) of Doxycycline-resistant bacteria out of all bacteria that were cultured during bacteriology test from subjects with adjudicated SSI.
    - Number (percent) of subjects who experienced adjudicated SSI during 30 days post-surgery that were treated by IV antibiotic.
    - Number of IV antibiotic treatment days, administered to subjects who experience adjudicated SSI during 30 days postsurgery.
    - Average of subjects’ cumulative ASEPSIS assessment score (AUC) for subjects with adjudicated SSI during 30 days.
    - Number (percent) of subjects with at least 1 score of ASEPSIS > 20 in subject with adjudicated SSI within 30 days post abdominal index surgery.
    Identification of an SSI will be based on CDC/NHSN Patient Safety
    Component Manual criteria (January 2020, chapter 9)
    Endpoint chiave:
    - Tasso di infezioni misurato dalla proporzione di soggetti con almeno un evento di infezione dell'incisione addominale target, verificatosi entro 30 giorni dall'intervento chirurgico addominale e determinato da un comitato giudicante indipendente e in cieco.
    - Numero (percentuale) di soggetti con almeno 1 punteggio ASEP-SIS > 20, entro 30 giorni dall'intervento chirurgico addominale.
    Ulteriori endpoint:
    - Incidenza di SSSI nei 30 giorni successivi all'intervento chirurgico indice.
    - Incidenza di DSSI nei 30 giorni successivi all'intervento chirurgico indice.
    - Tasso di mortalità da qualsiasi causa entro 30 giorni dalla randomizzazione.
    - Tasso di mortalità da qualsiasi causa entro 60 giorni dalla randomizzazione.
    - Tempo fino al riconoscimento della SSI nei 30 giorni successivi all'intervento chirurgico indice.
    - Numero (percentuale) di soggetti nuovamente ricoverati durante i 30 giorni successivi all'intervento chirurgico (per qualsiasi motivo) che hanno sofferto di SSI riconosciute durante tale nuovo ricovero.
    - Numero (percentuale) di soggetti che hanno fatto registrare almeno 1 nuovo intervento chirurgico a causa di SSI riconosciute nel corso dei 30 giorni dopo l'intervento.
    Endpoint aggiuntivi correlati a SSI:
    - Numero (percentuale) di soggetti con SSI riconosciuta per i quali nei test batteriologici si è sviluppato almeno un tipo di batteri resistente alla doxiciclina.
    - Numero (percentuale) di batteri resistenti alla doxiciclina rispetto a tutti i batteri sottoposti a esame colturale durante il test batteriologico relativo ai soggetti con SSI confermata.
    - Numero (percentuale) di soggetti che con SSI confermata durante i 30 giorni successivi all'intervento chirurgico trattati con antibiotici EV.
    - Numero di giorni di trattamento antibiotico EV somministrato ai soggetti con SSI confermata nei 30 giorni successivi all'intervento.
    - Media del punteggio cumulativo di valutazione ASEPSIS (AUC) per i soggetti con SSI confermata nel corso di 30 giorni.
    - Numero (percentuale) di soggetti con almeno 1 punteggio ASEPSIS > 20 in soggetti con SSI confermata entro 30 giorni dall'intervento chirurgico addominale indice.
    L'identificazione di una SSI si baserà sui criteri del Manuale CDC/NHSN per la sicurezza dei pazienti (gennaio 2020, capitolo 9)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 60 days
    30 giorni, 60 giorni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Trattamento antibiotico profilattico secondo Standard di Cura
    Standard of Care IV prophylactic Antibiotic Treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Serbia
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS (Last Visit Last Subject)
    UVUS (Ultima Visita Ultimo Soggetto)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state144
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 1400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The product is to be administered on a single occasion prior to surgical wound closure following abdominal surgical procedures.
    Il prodotto deve essere somministrato una sola volta prima della chiusura chirurgica dell'incisione dopo procedure chirurgiche addominali.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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