<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/NCT04496180</url>
  </required_header>
  <id_info>
    <org_study_id>UNGeneva</org_study_id>
    <nct_id>NCT04496180</nct_id>
  </id_info>
  <brief_title>Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy</brief_title>
  <acronym>CiPNT/SSI</acronym>
  <official_title>Standard Wound Dressing Versus Prophylactic Negative-pressure Wound Therapy After Emergency Laparotomy: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-operative wound complications in abdominal surgery have a major impact on patient&#xD;
      outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not&#xD;
      clear in the literature moreover concerning its potential economic benefits The hypothesis of&#xD;
      this study is that CINPt has the potential to reduce Surgical Site Infections.&#xD;
&#xD;
      Secondly the investigators aim to study the economic impact of CINPt used after abdominal&#xD;
      emergency laparotomies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the&#xD;
      most frequent wound occurrences are represented by wound infections, skin dehiscence or&#xD;
      parietal hernias.&#xD;
&#xD;
      Despite standard surgical aseptically technique and perioperative prevention management of&#xD;
      infections (e.g. antibiotics), wound complications after emergency laparotomies are still an&#xD;
      important unmet challenge.&#xD;
&#xD;
      Moreover, all these complications increase the cost of care requiring new managements.&#xD;
&#xD;
      CINPt has been longly used to favour the successful healing of a plethora of open wounds.&#xD;
&#xD;
      In particular CINPt is based on the application of local negative pressure to the wound&#xD;
      surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal&#xD;
      dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed&#xD;
      central foam, which is placed on the surface of the viscera. Then, two layers of porous&#xD;
      sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is&#xD;
      placed over the foam and the wound to seal the abdominal cavity. The entire system is then&#xD;
      connected, by suction tubes, to a device which ubiquitously applies negative pressure&#xD;
      (cyclically or continuously) on the surface. The fluid from the wound is collected into a&#xD;
      container. The benefits of negative pressure wound therapy have been reported to include&#xD;
      removal of infectious material, reduction in oedema and improved perfusion to tissue. Since&#xD;
      few years, a new negative pressure wound therapy has been created for closed wounds to reduce&#xD;
      time of healing and avoid wound complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Study Type: Interventional (Clinical Trial)&#xD;
Estimated Enrollment: 334&#xD;
Allocation: Randomized control trial&#xD;
Intervention Model: Parallel Assignment&#xD;
Intervention Model Description: 2 separate treatment arms&#xD;
Primary Purpose: Prevention&#xD;
Official Title: Standard wound dressing versus prophylactic negative-pressure wound therapy after emergency laparotomy&#xD;
Estimated Study Start Date: 09.2020&#xD;
Estimated Primary Completion Date:09.2021&#xD;
Estimated Study Completion Date: 09.2025</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine if the use of prophylactic negative-pressure wound therapy (Prevena) reduces the incidence of superficial surgical site infection after emergency laparotomy in patients at high-risk for SSI</measure>
    <time_frame>up to 30 days post procedure</time_frame>
    <description>Any SSI may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Superficial site infection will be assessed by Wound Classification System Using the American College of Surgeons National Surgical Quality Improvement Program ACS-NSQIP :&#xD;
Clean; these are uninfected operative wounds in which no inflammation.&#xD;
Clean/contaminated; These are operative wounds in which the respiratory, alimentary, genital, or urinary tract is entered Under controlled conditions and without unusual contamination.&#xD;
Contaminated; These include open, fresh, accidental wounds, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, non-purulent inflammation is encountered.&#xD;
Dirty ; These include old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay (LOS) in days.</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Return to Operating Room (ROR)</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rates of wound complications</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Individual rates of the incidence of each of the following: dehiscence (skin or fascia), seroma, lymph leak, infection, hematoma, ischemia and necrosis.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>A rate of parietal incisional hernia apparition after surgery</measure>
    <time_frame>2 years post procedure</time_frame>
    <description>This complication rate is multifactorial can be related to:&#xD;
An wall abcess&#xD;
Obesity with a BMI &gt; 35 Kg/m2&#xD;
medications&#xD;
Malnutrition&#xD;
Being an elderly adult&#xD;
Smoking&#xD;
Cancer&#xD;
a weak immune system&#xD;
diabetes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">334</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Length of Stay</condition>
  <condition>Seroma</condition>
  <condition>Hematoma</condition>
  <arm_group>
    <arm_group_label>PREVENA (CiPNT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply all parts just after the surgical procedure.&#xD;
A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators.&#xD;
The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital.&#xD;
The specialized nurse who will take a photo and assess the condition of the wound in the treatment room.&#xD;
One of the investigators, non-operators, who will also assess the condition of the wound by photo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simple dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Simple dressing; standard, waterproof dressing applied to wound</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies</intervention_name>
    <description>Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply the PREVENA just after the surgical procedure.&#xD;
A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators.&#xD;
The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital.&#xD;
The specialized nurse who will take a photo and assess the condition of the wound in the treatment room.&#xD;
One of the investigators, non-operators, who will also assess the condition of the wound by photo.</description>
    <arm_group_label>PREVENA (CiPNT)</arm_group_label>
    <arm_group_label>Simple dressing</arm_group_label>
    <other_name>PREVENA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient&#xD;
&#xD;
          -  ≥10cm emergency median laparotomy&#xD;
&#xD;
          -  Abdominal wall and skin closure in first intent&#xD;
&#xD;
          -  Septic peritoneal cavity (purulent and/or fecaloid free liquid and/or abscess)&#xD;
&#xD;
          -  Informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No abdominal wound closure in first intent&#xD;
&#xD;
          -  Allergy or hypersensitivity to silver&#xD;
&#xD;
          -  Application of a mesh for abdominal wall closure&#xD;
&#xD;
          -  Patients under corticosteroids or other immunosuppressive treatment.&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding.&#xD;
&#xD;
          -  Intention to become pregnant during the course of the study.&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant.&#xD;
&#xD;
          -  Previous enrolment in the current study.&#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_contact>
    <last_name>Ziad Abbassi, M.D.</last_name>
    <phone>0041766931667</phone>
    <email>Ziad.abbassi@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jérémy Meyer, Ph.D.</last_name>
    <phone>0041763161984</phone>
    <email>Jeremy.meyer@hcuge.ch</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Conde-Green A, Chung TL, Holton LH 3rd, Hui-Chou HG, Zhu Y, Wang H, Zahiri H, Singh DP. Incisional negative-pressure wound therapy versus conventional dressings following abdominal wall reconstruction: a comparative study. Ann Plast Surg. 2013 Oct;71(4):394-7. doi: 10.1097/SAP.0b013e31824c9073.</citation>
    <PMID>22868327</PMID>
  </results_reference>
  <results_reference>
    <citation>Gorgulu T. A Complication of Management of Closed Incision with Negative-Pressure Wound Therapy. Aesthet Surg J. 2015 Jul;35(5):NP113-5. doi: 10.1093/asj/sju120. Epub 2015 May 29. No abstract available.</citation>
    <PMID>26026135</PMID>
  </results_reference>
  <results_reference>
    <citation>Dohmen PM, Misfeld M, Borger MA, Mohr FW. Closed incision management with negative pressure wound therapy. Expert Rev Med Devices. 2014 Jul;11(4):395-402. doi: 10.1586/17434440.2014.911081. Epub 2014 Apr 22.</citation>
    <PMID>24754343</PMID>
  </results_reference>
  <results_reference>
    <citation>Ingargiola MJ, Daniali LN, Lee ES. Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Eplasty. 2013 Sep 20;13:e49. eCollection 2013.</citation>
    <PMID>24106562</PMID>
  </results_reference>
  <results_reference>
    <citation>Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25.</citation>
    <PMID>21868417</PMID>
  </results_reference>
  <results_reference>
    <citation>Vargo D. Negative pressure wound therapy in the prevention of wound infection in high risk abdominal wound closures. Am J Surg. 2012 Dec;204(6):1021-3; discussion 1023-4. doi: 10.1016/j.amjsurg.2012.10.004.</citation>
    <PMID>23231938</PMID>
  </results_reference>
  <results_reference>
    <citation>Zaidi A, El-Masry S. Closed-incision negative-pressure therapy in high-risk general surgery patients following laparotomy: a retrospective study. Colorectal Dis. 2017 Mar;19(3):283-287. doi: 10.1111/codi.13458.</citation>
    <PMID>27416813</PMID>
  </results_reference>
  <results_reference>
    <citation>Gunatilake RP, Swamy GK, Brancazio LR, Smrtka MP, Thompson JL, Gilner JB, Gray BA, Heine RP. Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial. AJP Rep. 2017 Jul;7(3):e151-e157. doi: 10.1055/s-0037-1603956. Epub 2017 Jul 14.</citation>
    <PMID>28717587</PMID>
  </results_reference>
  <results_reference>
    <citation>Reddix RN Jr, Tyler HK, Kulp B, Webb LX. Incisional vacuum-assisted wound closure in morbidly obese patients undergoing acetabular fracture surgery. Am J Orthop (Belle Mead NJ). 2009 Sep;38(9):446-9.</citation>
    <PMID>19911098</PMID>
  </results_reference>
  <results_reference>
    <citation>Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.</citation>
    <PMID>21804414</PMID>
  </results_reference>
  <results_reference>
    <citation>Pauser J, Nordmeyer M, Biber R, Jantsch J, Kopschina C, Bail HJ, Brem MH. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. 2016 Oct;13(5):663-7. doi: 10.1111/iwj.12344. Epub 2014 Aug 14.</citation>
    <PMID>25125244</PMID>
  </results_reference>
  <results_reference>
    <citation>Redfern RE, Cameron-Ruetz C, O'Drobinak SK, Chen JT, Beer KJ. Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3333-3339. doi: 10.1016/j.arth.2017.06.019. Epub 2017 Jun 17.</citation>
    <PMID>28705547</PMID>
  </results_reference>
  <results_reference>
    <citation>Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.</citation>
    <PMID>23539123</PMID>
  </results_reference>
  <results_reference>
    <citation>Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.</citation>
    <PMID>26313829</PMID>
  </results_reference>
  <results_reference>
    <citation>Wiegering A, Dietz UA, Corteville C, Plassmeier L, Jurowich C, Germer CT, Krajinovic K. Impact of incisional negative pressure wound therapy on perineal wound healing after abdominoperineal rectum extirpation. Int J Colorectal Dis. 2017 Feb;32(2):291-293. doi: 10.1007/s00384-016-2704-5. Epub 2016 Nov 14.</citation>
    <PMID>27844201</PMID>
  </results_reference>
  <results_reference>
    <citation>Bonds AM, Novick TK, Dietert JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 2013 Dec;56(12):1403-8. doi: 10.1097/DCR.0b013e3182a39959.</citation>
    <PMID>24201395</PMID>
  </results_reference>
  <results_reference>
    <citation>Webster J, Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD009261. doi: 10.1002/14651858.CD009261.pub4.</citation>
    <PMID>30912582</PMID>
  </results_reference>
  <results_reference>
    <citation>Zwanenburg PR, Tol BT, Obdeijn MC, Lapid O, Gans SL, Boermeester MA. Meta-analysis, Meta-regression, and GRADE Assessment of Randomized and Nonrandomized Studies of Incisional Negative Pressure Wound Therapy Versus Control Dressings for the Prevention of Postoperative Wound Complications. Ann Surg. 2020 Jul;272(1):81-91. doi: 10.1097/SLA.0000000000003644.</citation>
    <PMID>31592899</PMID>
  </results_reference>
  <results_reference>
    <citation>Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015 Jan 1;4(1):1. doi: 10.1186/2046-4053-4-1.</citation>
    <PMID>25554246</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Abbassi Ziad</investigator_full_name>
    <investigator_title>Principal investigator, M.D.</investigator_title>
  </responsible_party>
  <keyword>pNPWT</keyword>
  <keyword>PREVENA</keyword>
  <keyword>SSI</keyword>
  <keyword>morbidity</keyword>
  <keyword>dehiscence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_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/NCT04496180
org study id: UNGeneva
nct id: NCT04496180
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Post-operative wound complications in abdominal surgery have a major impact on patient
      outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not
      clear in the literature moreover concerning its potential economic benefits The hypothesis of
      this study is that CINPt has the potential to reduce Surgical Site Infections.

      Secondly the investigators aim to study the economic impact of CINPt used after abdominal
      emergency laparotomies.
Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the
      most frequent wound occurrences are represented by wound infections, skin dehiscence or
      parietal hernias.

      Despite standard surgical aseptically technique and perioperative prevention management of
      infections (e.g. antibiotics), wound complications after emergency laparotomies are still an
      important unmet challenge.

      Moreover, all these complications increase the cost of care requiring new managements.

      CINPt has been longly used to favour the successful healing of a plethora of open wounds.

      In particular CINPt is based on the application of local negative pressure to the wound
      surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal
      dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed
      central foam, which is placed on the surface of the viscera. Then, two layers of porous
      sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is
      placed over the foam and the wound to seal the abdominal cavity. The entire system is then
      connected, by suction tubes, to a device which ubiquitously applies negative pressure
      (cyclically or continuously) on the surface. The fluid from the wound is collected into a
      container. The benefits of negative pressure wound therapy have been reported to include
      removal of infectious material, reduction in oedema and improved perfusion to tissue. Since
      few years, a new negative pressure wound therapy has been created for closed wounds to reduce
      time of healing and avoid wound complications.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 334
Allocation: Randomized control trial
Intervention Model: Parallel Assignment
Intervention Model Description: 2 separate treatment arms
Primary Purpose: Prevention
Official Title: Standard wound dressing versus prophylactic negative-pressure wound therapy after emergency laparotomy
Estimated Study Start Date: 09.2020
Estimated Primary Completion Date:09.2021
Estimated Study Completion Date: 09.2025
primary purpose: Prevention
masking: None (Open Label)
measure: To determine if the use of prophylactic negative-pressure wound therapy (Prevena) reduces the incidence of superficial surgical site infection after emergency laparotomy in patients at high-risk for SSI
time frame: up to 30 days post procedure
description: Any SSI may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Superficial site infection will be assessed by Wound Classification System Using the American College of Surgeons National Surgical Quality Improvement Program ACS-NSQIP :
Clean; these are uninfected operative wounds in which no inflammation.
Clean/contaminated; These are operative wounds in which the respiratory, alimentary, genital, or urinary tract is entered Under controlled conditions and without unusual contamination.
Contaminated; These include open, fresh, accidental wounds, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, non-purulent inflammation is encountered.
Dirty ; These include old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera.
measure: Length of stay (LOS) in days.
time frame: 30 days post procedure
description: LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complications.
measure: 30-day Return to Operating Room (ROR)
time frame: 30 days post procedure
description: Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation.
measure: Incidence rates of wound complications
time frame: 30 days post procedure
description: Individual rates of the incidence of each of the following: dehiscence (skin or fascia), seroma, lymph leak, infection, hematoma, ischemia and necrosis.
measure: A rate of parietal incisional hernia apparition after surgery
time frame: 2 years post procedure
description: This complication rate is multifactorial can be related to:
An wall abcess
Obesity with a BMI > 35 Kg/m2
medications
Malnutrition
Being an elderly adult
Smoking
Cancer
a weak immune system
diabetes
arm group label: PREVENA (CiPNT)
arm group type: Experimental
description: Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply all parts just after the surgical procedure.
A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators.
The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital.
The specialized nurse who will take a photo and assess the condition of the wound in the treatment room.
One of the investigators, non-operators, who will also assess the condition of the wound by photo.
arm group label: Simple dressing
arm group type: Active Comparator
description: Simple dressing; standard, waterproof dressing applied to wound
intervention type: Device
intervention name: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies
description: Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply the PREVENA just after the surgical procedure.
A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators.
The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital.
The specialized nurse who will take a photo and assess the condition of the wound in the treatment room.
One of the investigators, non-operators, who will also assess the condition of the wound by photo.
arm group label: PREVENA (CiPNT)
arm group label: Simple dressing
other name: PREVENA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ziad Abbassi, M.D.
phone: 0041766931667
email: Ziad.abbassi@hcuge.ch
last name: Jérémy Meyer, Ph.D.
phone: 0041763161984
email: Jeremy.meyer@hcuge.ch
citation: Conde-Green A, Chung TL, Holton LH 3rd, Hui-Chou HG, Zhu Y, Wang H, Zahiri H, Singh DP. Incisional negative-pressure wound therapy versus conventional dressings following abdominal wall reconstruction: a comparative study. Ann Plast Surg. 2013 Oct;71(4):394-7. doi: 10.1097/SAP.0b013e31824c9073.
PMID: 22868327
citation: Gorgulu T. A Complication of Management of Closed Incision with Negative-Pressure Wound Therapy. Aesthet Surg J. 2015 Jul;35(5):NP113-5. doi: 10.1093/asj/sju120. Epub 2015 May 29. No abstract available.
PMID: 26026135
citation: Dohmen PM, Misfeld M, Borger MA, Mohr FW. Closed incision management with negative pressure wound therapy. Expert Rev Med Devices. 2014 Jul;11(4):395-402. doi: 10.1586/17434440.2014.911081. Epub 2014 Apr 22.
PMID: 24754343
citation: Ingargiola MJ, Daniali LN, Lee ES. Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Eplasty. 2013 Sep 20;13:e49. eCollection 2013.
PMID: 24106562
citation: Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25.
PMID: 21868417
citation: Vargo D. Negative pressure wound therapy in the prevention of wound infection in high risk abdominal wound closures. Am J Surg. 2012 Dec;204(6):1021-3; discussion 1023-4. doi: 10.1016/j.amjsurg.2012.10.004.
PMID: 23231938
citation: Zaidi A, El-Masry S. Closed-incision negative-pressure therapy in high-risk general surgery patients following laparotomy: a retrospective study. Colorectal Dis. 2017 Mar;19(3):283-287. doi: 10.1111/codi.13458.
PMID: 27416813
citation: Gunatilake RP, Swamy GK, Brancazio LR, Smrtka MP, Thompson JL, Gilner JB, Gray BA, Heine RP. Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial. AJP Rep. 2017 Jul;7(3):e151-e157. doi: 10.1055/s-0037-1603956. Epub 2017 Jul 14.
PMID: 28717587
citation: Reddix RN Jr, Tyler HK, Kulp B, Webb LX. Incisional vacuum-assisted wound closure in morbidly obese patients undergoing acetabular fracture surgery. Am J Orthop (Belle Mead NJ). 2009 Sep;38(9):446-9.
PMID: 19911098
citation: Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.
PMID: 21804414
citation: Pauser J, Nordmeyer M, Biber R, Jantsch J, Kopschina C, Bail HJ, Brem MH. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. 2016 Oct;13(5):663-7. doi: 10.1111/iwj.12344. Epub 2014 Aug 14.
PMID: 25125244
citation: Redfern RE, Cameron-Ruetz C, O'Drobinak SK, Chen JT, Beer KJ. Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3333-3339. doi: 10.1016/j.arth.2017.06.019. Epub 2017 Jun 17.
PMID: 28705547
citation: Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3.
PMID: 23539123
citation: Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519.
PMID: 26313829
citation: Wiegering A, Dietz UA, Corteville C, Plassmeier L, Jurowich C, Germer CT, Krajinovic K. Impact of incisional negative pressure wound therapy on perineal wound healing after abdominoperineal rectum extirpation. Int J Colorectal Dis. 2017 Feb;32(2):291-293. doi: 10.1007/s00384-016-2704-5. Epub 2016 Nov 14.
PMID: 27844201
citation: Bonds AM, Novick TK, Dietert JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 2013 Dec;56(12):1403-8. doi: 10.1097/DCR.0b013e3182a39959.
PMID: 24201395
citation: Webster J, Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD009261. doi: 10.1002/14651858.CD009261.pub4.
PMID: 30912582
citation: Zwanenburg PR, Tol BT, Obdeijn MC, Lapid O, Gans SL, Boermeester MA. Meta-analysis, Meta-regression, and GRADE Assessment of Randomized and Nonrandomized Studies of Incisional Negative Pressure Wound Therapy Versus Control Dressings for the Prevention of Postoperative Wound Complications. Ann Surg. 2020 Jul;272(1):81-91. doi: 10.1097/SLA.0000000000003644.
PMID: 31592899
citation: Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015 Jan 1;4(1):1. doi: 10.1186/2046-4053-4-1.
PMID: 25554246
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Abbassi Ziad
investigator title: Principal investigator, M.D.
mesh term: Infections
mesh term: Surgical Wound Infection
mesh term: Emergencies
mesh term: Hematoma