<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04476212</url>
  </required_header>
  <id_info>
    <org_study_id>20171013</org_study_id>
    <nct_id>NCT04476212</nct_id>
  </id_info>
  <brief_title>Prophylaxis of Surgical Wound Infection With Topical Antibiotics</brief_title>
  <official_title>Prophylaxis of Surgical Wound Infection With Topical Antibiotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Granollers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Granollers</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical site infection (SSI) is the main complication of surgery. The prevention of&#xD;
      superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with&#xD;
      topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive&#xD;
      results. In experimental conditions there is evidence in favor of the efficiency wound lavage&#xD;
      with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety&#xD;
      and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic&#xD;
      therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk&#xD;
      of infection. Method. Project comprising several randomized double-blind clinical trials with&#xD;
      a common methodology. Procedures with varying degrees of contamination, as emergency&#xD;
      abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied.&#xD;
      Follow-up will be 30 days after operation. Data will be collected anonymously and the&#xD;
      relationships between the variables will be analyzed using Pearson's chi-square, survival&#xD;
      analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on&#xD;
      hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several Surgical site infection (SSI) prevention guidelines have been published over the last&#xD;
      10 years. Topical prophylaxis of the surgical wound with antibiotics or antiseptics is one of&#xD;
      the most controversial measures proposed for SSI prevention. Two guidelines (British, Spanish&#xD;
      Ministry of Health) explicitly recommend not irrigating surgical wounds with any product. The&#xD;
      World Health Organization considers irrigation with antibiotics as an unresolved issue and,&#xD;
      together with the Centers for Disease Control, recommends irrigation with a solution of&#xD;
      povidone iodine. The other four guides do not mention the measure. In Catalonia, a SSI&#xD;
      prevention bundle recommends wound irrigation with saline, with a low level of&#xD;
      recommendation.&#xD;
&#xD;
      Therefore, topical prophylaxis with operational wound washings with different solutions has&#xD;
      been poorly studied, evokes contradictory recommendations and is not included in the majority&#xD;
      of clinical practice guidelines for SSI prevention.&#xD;
&#xD;
      However, there we detected a high level of use of wound irrigation at the end of an&#xD;
      intervention in actual clinical practice. In a survey conducted by 2017 by our group and&#xD;
      answered by 845 general surgeons of the Spanish Association of Surgeons, before closing the&#xD;
      skin, most surgeons (80.6%) irrigate the subcutaneous layer of the wound, either with saline&#xD;
      (51.2%), an antiseptic solution (23.8%) or an antibiotic solution (1.5%). Only 19.4% of&#xD;
      respondents do not irrigate. In another survey in 2018, focused on colorectal surgeons of two&#xD;
      Spanish associations, similar rates of irrigation with saline, antiseptic or antibiotic were&#xD;
      used (55%, 28.9% and 2.2%, respectively) The hypothesis of the study is that topical&#xD;
      prophylaxis of the surgical wound with irrigation with an antibiotic solution decreases the&#xD;
      rate of postoperative infection in patients undergoing abdominal surgery with different&#xD;
      levels of contamination.&#xD;
&#xD;
      The study will compare the efficacy of topical prophylaxis in the surgical wound with an&#xD;
      irrigation with an antibiotic solution in the incidence of SSI in abdominal surgery.&#xD;
&#xD;
      It is a randomized, controlled, multicenter, blind study by observer and patient, with two&#xD;
      parallel study groups, phase IV.&#xD;
&#xD;
      Design of studies The project includes several prospective comparative studies on the effect&#xD;
      of irrigation of surgical wounds with an antibiotic solution on the incisional SSI rate in&#xD;
      abdominal surgery. The studies share a unique methodology applied to various types of&#xD;
      abdominal surgery with different expected SSI rates and different risk factors.&#xD;
&#xD;
      In the trials, the irrigation of the wound with 0.9% physiological serum will be compared&#xD;
      with the irrigation with an active principle solution of a pharmaceutical specialty of proven&#xD;
      efficacy by parenteral route, administered topically and dissolved in physiological serum.&#xD;
&#xD;
      Four studies on different types of operations are defined according to the risk of infection:&#xD;
&#xD;
        -  Study 1. Complex abdominal wall surgery&#xD;
&#xD;
        -  Study 2. Cesarean section&#xD;
&#xD;
        -  Study 3. Colorectal elective surgery&#xD;
&#xD;
        -  Study 4. Emergency abdominal surgery For each study two groups will be formed, the study&#xD;
           group (irrigation with antibiotic solution) and the control group (irrigation with&#xD;
           saline).&#xD;
&#xD;
      The project has received the Spanish Drug Agency authorization as a low intervention study, a&#xD;
      grant from the Spanish Ministry of Health and the Ethics Committee authorization of the&#xD;
      Hospital General of Granollers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 27, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV. The irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with a solution of amoxicillin-clavulanate, administered topically and dissolved in saline.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>There will be masking for the patient, for the surgeon responsible for the case, for the investigator responsible for each study, for the coordinator of the center and for the main investigator. After the closure of the abdominal fascia, the patients will be randomized to one of the study groups. The circulating nurse will open the randomization envelope and prepare the solution indicated on the outside of the operating room. He/she will record the case on the database and will be the only person with knowledge of the group allocation of the case.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Site infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>signs of infection at any level of surgical site</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications after surgery</measure>
    <time_frame>30 days</time_frame>
    <description>Any complication after surgery, evaluated by the Clavien-dindo classification</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">560</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Surgery--Complications</condition>
  <condition>Colorectal Surgery</condition>
  <condition>Cesarean Section; Infection</condition>
  <condition>Hernia, Abdominal</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental arm, the surgical wound will be irrigated using an antibiotic solution (amoxicillin-clavulanate) for topical prophylaxis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control arm, the surgical wound will be irrigated with saline, which is our routine at present.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Topical antibiotic prophylaxis</intervention_name>
    <description>The surgical wound will be irrigated with an antibiotic solution, and then we will apply the same solution using gauze for two minutes on the wound</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted for elective abdominal wall surgery by open route&#xD;
&#xD;
          -  Patients admitted for urgent or elective cesarean section&#xD;
&#xD;
          -  Patients undergoing elective surgery of the colon or rectum for neoplastic pathology&#xD;
             (open or laparoscopy)&#xD;
&#xD;
          -  Patients undergoing emergency abdominal surgery (open or laparoscopy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under treatment with immunosuppressors, corticosteroids and patients on&#xD;
             hemodialysis&#xD;
&#xD;
          -  Patients with primary peritonitis and liver cirrhosis&#xD;
&#xD;
          -  Patients with suspected allergy to the antibiotic used in the study&#xD;
&#xD;
          -  Patients who have recently undergone open abdomen surgery (up to 30 days&#xD;
             pre-intervention) or to which the wound can not be closed surgical according to the&#xD;
             surgeon's criteria&#xD;
&#xD;
          -  Patients with American Society of Anaesthesiology classification 5.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josep Maria Badia, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Privada Hospital Asil de Granollers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Felipe Ojeda, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundació Privada Hospital Asil de Granollers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Josep Maria Badia, PhD</last_name>
    <phone>(+34) 938 425 000</phone>
    <phone_ext>2571</phone_ext>
    <email>jmbadia@fhag.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gemma Molist, PhD</last_name>
    <phone>(+34) 938 425 000</phone>
    <phone_ext>2973</phone_ext>
    <email>recerca@fjah.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fundació Privada Hospital Asil de Granollers</name>
      <address>
        <city>Granollers</city>
        <state>Barcelona</state>
        <zip>08402</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Josep Maria Badia, PhD</last_name>
      <phone>(+34) 938 425 000</phone>
      <phone_ext>2571</phone_ext>
      <email>jmbadia@fhag.es</email>
    </contact>
    <contact_backup>
      <last_name>Gemma Molist, PhD</last_name>
      <phone>(+34) 938 425 000</phone>
      <phone_ext>2973</phone_ext>
      <email>recerca@fhag.es</email>
    </contact_backup>
    <investigator>
      <last_name>Josep Maria Badia, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Felipe Ojeda, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical site infection</keyword>
  <keyword>Prevention</keyword>
  <keyword>Topical prophylaxis</keyword>
  <keyword>Wound irrigation</keyword>
  <keyword>Topical antibiotic prophylaxis</keyword>
  <keyword>Abdominal surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04476212
org study id: 20171013
nct id: NCT04476212
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Surgical site infection (SSI) is the main complication of surgery. The prevention of
      superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with
      topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive
      results. In experimental conditions there is evidence in favor of the efficiency wound lavage
      with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety
      and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic
      therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk
      of infection. Method. Project comprising several randomized double-blind clinical trials with
      a common methodology. Procedures with varying degrees of contamination, as emergency
      abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied.
      Follow-up will be 30 days after operation. Data will be collected anonymously and the
      relationships between the variables will be analyzed using Pearson's chi-square, survival
      analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on
      hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.
Several Surgical site infection (SSI) prevention guidelines have been published over the last
      10 years. Topical prophylaxis of the surgical wound with antibiotics or antiseptics is one of
      the most controversial measures proposed for SSI prevention. Two guidelines (British, Spanish
      Ministry of Health) explicitly recommend not irrigating surgical wounds with any product. The
      World Health Organization considers irrigation with antibiotics as an unresolved issue and,
      together with the Centers for Disease Control, recommends irrigation with a solution of
      povidone iodine. The other four guides do not mention the measure. In Catalonia, a SSI
      prevention bundle recommends wound irrigation with saline, with a low level of
      recommendation.

      Therefore, topical prophylaxis with operational wound washings with different solutions has
      been poorly studied, evokes contradictory recommendations and is not included in the majority
      of clinical practice guidelines for SSI prevention.

      However, there we detected a high level of use of wound irrigation at the end of an
      intervention in actual clinical practice. In a survey conducted by 2017 by our group and
      answered by 845 general surgeons of the Spanish Association of Surgeons, before closing the
      skin, most surgeons (80.6%) irrigate the subcutaneous layer of the wound, either with saline
      (51.2%), an antiseptic solution (23.8%) or an antibiotic solution (1.5%). Only 19.4% of
      respondents do not irrigate. In another survey in 2018, focused on colorectal surgeons of two
      Spanish associations, similar rates of irrigation with saline, antiseptic or antibiotic were
      used (55%, 28.9% and 2.2%, respectively) The hypothesis of the study is that topical
      prophylaxis of the surgical wound with irrigation with an antibiotic solution decreases the
      rate of postoperative infection in patients undergoing abdominal surgery with different
      levels of contamination.

      The study will compare the efficacy of topical prophylaxis in the surgical wound with an
      irrigation with an antibiotic solution in the incidence of SSI in abdominal surgery.

      It is a randomized, controlled, multicenter, blind study by observer and patient, with two
      parallel study groups, phase IV.

      Design of studies The project includes several prospective comparative studies on the effect
      of irrigation of surgical wounds with an antibiotic solution on the incisional SSI rate in
      abdominal surgery. The studies share a unique methodology applied to various types of
      abdominal surgery with different expected SSI rates and different risk factors.

      In the trials, the irrigation of the wound with 0.9% physiological serum will be compared
      with the irrigation with an active principle solution of a pharmaceutical specialty of proven
      efficacy by parenteral route, administered topically and dissolved in physiological serum.

      Four studies on different types of operations are defined according to the risk of infection:

        -  Study 1. Complex abdominal wall surgery

        -  Study 2. Cesarean section

        -  Study 3. Colorectal elective surgery

        -  Study 4. Emergency abdominal surgery For each study two groups will be formed, the study
           group (irrigation with antibiotic solution) and the control group (irrigation with
           saline).

      The project has received the Spanish Drug Agency authorization as a low intervention study, a
      grant from the Spanish Ministry of Health and the Ethics Committee authorization of the
      Hospital General of Granollers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV. The irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with a solution of amoxicillin-clavulanate, administered topically and dissolved in saline.
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: There will be masking for the patient, for the surgeon responsible for the case, for the investigator responsible for each study, for the coordinator of the center and for the main investigator. After the closure of the abdominal fascia, the patients will be randomized to one of the study groups. The circulating nurse will open the randomization envelope and prepare the solution indicated on the outside of the operating room. He/she will record the case on the database and will be the only person with knowledge of the group allocation of the case.
measure: Surgical Site infection rate
time frame: 30 days
description: signs of infection at any level of surgical site
measure: Complications after surgery
time frame: 30 days
description: Any complication after surgery, evaluated by the Clavien-dindo classification
arm group label: Intervention
arm group type: Experimental
description: In the experimental arm, the surgical wound will be irrigated using an antibiotic solution (amoxicillin-clavulanate) for topical prophylaxis
arm group label: Control
arm group type: No Intervention
description: In the control arm, the surgical wound will be irrigated with saline, which is our routine at present.
intervention type: Other
intervention name: Topical antibiotic prophylaxis
description: The surgical wound will be irrigated with an antibiotic solution, and then we will apply the same solution using gauze for two minutes on the wound
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josep Maria Badia, PhD
role: Principal Investigator
affiliation: Fundació Privada Hospital Asil de Granollers
last name: Felipe Ojeda, PhD
role: Principal Investigator
affiliation: Fundació Privada Hospital Asil de Granollers
last name: Josep Maria Badia, PhD
phone: (+34) 938 425 000
phone ext: 2571
email: jmbadia@fhag.es
last name: Gemma Molist, PhD
phone: (+34) 938 425 000
phone ext: 2973
email: recerca@fjah.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Spain
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Wound Infection
mesh term: Hernia, Abdominal
mesh term: Internal Hernia
mesh term: Surgical Wound
mesh term: Anti-Bacterial Agents