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    Summary
    EudraCT Number:2020-003617-36
    Sponsor's Protocol Code Number:D-PLEX312
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-10
    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 ConcernedPortugal - INFARMED
    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.
    Estudo de fase III, prospectivo, multinacional, multicêntrico, randomizado, controlado, com dois braços, duplo-cego para avaliar a eficácia e a segurança de D-PLEX administrado concomitantemente com os cuidados padrão (SoC), em comparação com um braço de controlo tratado com SoC, para a prevenção de infecções incisionais pós-cirurgia abdominal
    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.
    Estudo do D-PLEX na prevenção de infecções após cirurgias abdominais.
    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.
    Segurança e eficácia do D-PLEX na prevenção da infecção incisional pós-cirurgia abdominal.
    A.4.1Sponsor's protocol code numberD-PLEX312
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04411199
    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 pointPolyPid Clinical Department
    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 number0097274719 5700
    B.5.5Fax number0097274719 5718
    B.5.6E-mailclinical@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 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 typeequal
    D.3.10.3Concentration number1.26
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.
    Prevenção de infecção incisional pós-cirurgia abdominal.
    E.1.1.1Medical condition in easily understood language
    Prevention of post abdominal surgery incisional infection
    Prevenção de infecção incisional pós-cirurgia abdominal
    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).
    Avaliar a eficácia anti-infeciosa do D-PLEX administrado concomitantemente com os cuidados padrão (SoC) durante um período de 30 dias após a operação, prevenindo a infeção do local cirúrgico (ILC), definida como infeção superficial e/ou profunda, na incisão alvo, em comparação com o braço de controlo tratado com o SoC e avaliar a segurança do D-PLEX administrado concomitantemente com os cuidados padrão (SoC).
    E.2.2Secondary objectives of the trial
    Not applicable
    Não aplicável
    E.2.3Trial contains a sub-study No
    E.3Principal 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 ≥ 7cm (target incision).
    2.Subjects are preoperative hemodynamically stable. (BP≤180/110 and ≥90/60 mmHg, and HR≤100 and ≥60 bpm, and temperature ≤38.50C and ≥35.50C).
    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 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.
    1.Indivíduos submetidos a uma cirurgia colorretal eletiva que envolva ressecção, com ou sem formação de estoma, que inclua, pelo menos, 1 incisão abdominal ≥ 7 cm (incisão alvo).
    2.Indivíduos que estejam estáveis a nível hemodinâmico no pré-operatório. (TA≤180/110 e ≥90/60mmHg, e FC≤100 e ≥60bpm, e temperatura ≤38,5ºC e ≥35,5ºC.
    3.Homens ou mulheres que não estejam grávidas.
    4.As mulheres em idade fértil devem apresentar um teste de gravidez negativo (soro ou fita reagente urinária) antes do procedimento inicial.
    Nota: Todas as mulheres em idade fértil devem concordar com a utilização de um método de contraceção altamente eficaz de forma consistente e correta durante a duração do estudo (ver Secção 8.6 - MÉTODOS CONTRACETIVOS).
    5.Indivíduos maiores de 18 anos na altura do rastreio.
    6.Indivíduos que assinaram o Formulário de Consentimento Informado.
    7.Indivíduos que estejam dispostos e aptos a participar e preencham todos os requisitos do estudo.
    8.Expetativa de sobrevivência de, pelo menos, 60 dias após a aleatorização.
    E.4Principal 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, etc.)
    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 one week prior to randomization, excluding pre-operative prophylaxis or antibiotics for the treatment of the disease that is the indication for surgery.
    4. Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair for 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 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 condition.
    18. Psychiatric or any other disorder that compromises the 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).
    1. Indivíduos com perfuração intestinal suspeita/diagnosticada, abcesso intra-abdominal, ou qualquer cirurgia coloretal emergente/urgente com obstrução intestinal aguda (ex: colite tóxica, iléo/sub-iléo, megacólon, diverticulite, vólvulo, etc.)
    2. Indivíduos que foram submetidos a cirurgia intra-abdominal no período de 6 meses anteriores à aleatorização.
    3. Os indivíduos com qualquer infeção ativa pré-operatória ou que estejam a receber qualquer terapia antibiótica na semana anterior à aleatorização, excluindo profilaxia pré-operatória ou antibiótico para o tratamento da doença que consiste na indicação da cirurgia.
    4. Os indivíduos submetidos a procedimentos concomitantes significativos em adição à cirurgia abdominal, incluindo reparação concomitante de hérnia. Salpingo-ooforectomia e colecistectomia são permitidos..
    5. Indivíduos que receberam qualquer tratamento anti-cancro no período de 4 semanas antes da cirurgia.
    6. Indivíduos que receberam radiação para cancro colorretal na zona do abdómen, antes da cirurgia abdominal planeada.
    7. Indivíduos que receberam doxiciclina IV ou oral ou antibióticos da família da tetraciclina durante as últimas 4 semanas antes da aleatorização.
    8. Indivíduos com alergia conhecida à doxiciclina e/ou à medicamentos da família da tetraciclina ou aos excipientes do D-PLEX.
    9. Indivíduos com alergias conhecidas a mais de 3 substâncias (um questionário sobre alergias preenchido durante o processo de rastreio).
    10. Indivíduos com antecedentes de reações alérgicas graves a qualquer substância, tendo requerido tratamento com esteroides intravenosos/epinefrina intramuscular ou um indivíduo que, na opinião do Investigador, apresentem um alto risco de desenvolver reações alérgicas graves.
    11. Indivíduos com Doença Renal em Fase Terminal (DRFT/DRC na fase 5).
    12. Indivíduos com deficiência hepática grave.
    13. Indivíduos com urticária crónica.
    14. Indivíduos diagnosticados com AVC nos últimos 6 meses antes da aleatorização.
    15. Os indivíduos que foram submetidos a qualquer cirurgia abdominal e cuja cirurgia inicial atualmente planeada envolva a reabertura da cicatriz de uma cirurgia abdominal anterior realizada nos últimos 3 anos.
    16. Qualquer indivíduo com uma patologia maligna ativa, para além de cancro não-metastático colorectal potencialmente ressecável, que consiste na indicação da cirurgia inicial, ou carcinoma in situ (ou outro cancro "in situ = Fase 0"), ou carcinoma epidermoide ou carcinoma basocelular da pele, ou malignidade que não tenha estado em completa remissão clínica e sem quimioterapia ou imunoterapia há pelo menos 3 anos.
    17. Indivíduos com outras condições médicas concomitantes graves e/ou incontroladas .
    18. Perturbação psiquiátrica ou outra que comprometa a capacidade de disponibilizar o consentimento informado para a participação neste estudo.
    19. Indivíduos alcoólicos crónicos ou toxicodependentes.
    20. Mulheres grávidas ou a amamentar, ou mulheres em idade fértil que se recusem ou que estejam proibidas de utilizar um método contracetivo eficaz de controlo da natalidade durante a participação no estudo, incluindo o período de acompanhamento de segurança.
    21. Indivíduos que tenham recebido qualquer fármaco de investigação no período de 30 dias ou 5 meias-vidas anteriores à aleatorização doestudo (o que for mais longo) e durante o estudo.
    22. Indivíduos que estejam a participar em qualquer outro estudo de intervenção.
    23. Indivíduos que na opinião do Investigador, não sejam elegíveis para participar no estudo e/ou para cumprir os requisitos do protocolo (por exemplo, devido a uma condição cognitiva ou médica).
    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, occurring 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 re-interventions through the abdominal incision (target) within 30 days post index surgery will be analysed as treatment failure.
    Reintervention is defined as re-opening of the same target incision, used for the original index surgery, in the operation room (OR).
    An independent and blinded adjudication committee will review each case suspected for SSI and will adjudicate if meets the SSI endpoint criteria.
    Taxa de infeção, medida pela proporção de indivíduos com, pelo menos, um evento de infeção incisional abdominal alvo, que ocorra no período de 30 dias após a cirurgia abdominal e determinado por uma comissão de avaliação cega e independente.
    (A infeção incisional abdominal é definida como Infeção Incisional Profunda do Local Cirúrgico [IIPLC] e/ou Infeção Incisional Superficial do Local Cirúrgico [IISLC]).
    A mortalidade por todas as causas e as reintervenções através da incisão abdominal (alvo) no período de 30 dias após a cirurgia inicial serão analisadas como fracasso do tratamento.
    Reintervenção é definida como a reabertura da mesma incisão alvo, utilizada para a cirurgia inicial, no bloco operatório (BO).

    Uma comissão de avaliação independente e cega analisará cada caso suspeito de ILC e decidirá se preenche os parâmetros de ILC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 dias
    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, occurring 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 bacteriology 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)
    Parâmetros chave:
    -Taxa de infeção, medida pela proporção de indivíduos com, pelo menos, apenas um evento de infeção incisional abdominal alvo, que ocorra no período de 30 dias após a cirurgia abdominal e determinado por uma comissão de avaliação cega e independente.
    -Número (percentagem) de indivíduos com, pelo menos, 1 pontuação de ASEPSIS > 20, no período de 30 dias após a cirurgia abdominal.
    Parâmetros adicionais:
    -Incidência de IISLC no período de 30 dias após a cirurgia inicial.
    -Incidência de IIPLC no período de 30 dias após a cirurgia inicial.
    -Taxa de mortalidade por todas as causas no período de 30 dias após a aleatorização.
    -Taxa de mortalidade por todas as causas no período de 60 dias após a aleatorização.
    -Tempo decorrido até à ILC confirmada no período de 30 dias após a cirurgia inicial.
    -Número (percentagem) de indivíduos readmitidos no período de 30 dias pós-cirurgia (por qualquer razão) que tenham contraído a ILC confirmada durante esta readmissão.
    -Número (percentagem) de indivíduos que foram submetidos a, pelo menos, 1 reintervenção cirúrgica devido à ILC confirmada no período de 30 dias pós-cirurgia.
    Parâmetros Adicionais Relacionados com a ILC:
    -Número (percentagem) de indivíduos com a ILC confirmada, nos quais se tenha desenvolvido, pelo menos, uma bactéria resistente à doxiciclina em testes bacteriológicos.
    -Número (percentagem) de bactérias resistentes à doxiciclina de todas as bactérias que foram cultivadas durante o teste bacteriológico de indivíduos com a ILC confirmada.
    -Número (percentagem) de indivíduos que tenham contraído a ILC confirmada no período de 30 dias pós-cirurgia que foram tratados com antibiótico IV.
    -Número de dias de tratamento com antibiótico IV, administrado a indivíduos que contraiam a ILC confirmada no período de 30 dias pós-cirurgia.
    -Média da pontuação acumulada de avaliação ASEPSIS (AUC) dos indivíduos com a ILC confirmada durante 30 dias.
    -Número (percentagem) de indivíduos com, pelo menos, 1 pontuação de ASEPSIS > 20 em indivíduo com a ILC confirmada, no período de 30 dias após a cirurgia abdominal inicial.
    A identificação de uma ILC terá por base os critérios do "CDC/NHSN Patient Safety Component Manual" (janeiro 2020, capítulo 9)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days, 60 days
    30 dias, 60 dias
    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
    Cuidados padrão tratamento antibiótico profilático IV
    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 concerned5
    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 No
    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
    United States
    Serbia
    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
    Última visita do último paciente
    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 state72
    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.
    O produto deve ser administrado numa ocasião única antes da sutura da incisão, após os procedimentos cirúrgicos abdominais.
    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 Decision2021-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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