<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/NCT04434820</url>
  </required_header>
  <id_info>
    <org_study_id>642357</org_study_id>
    <nct_id>NCT04434820</nct_id>
  </id_info>
  <brief_title>External Negative Pressure Dressing System vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.</brief_title>
  <official_title>External Negative Pressure Dressing System (ENPDS) vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity is associated with increased cesarean section delivery rates and surgical site&#xD;
      infections with associated increased post-operative morbidity, post-operative pain and length&#xD;
      of hospital stay.&#xD;
&#xD;
      Negative pressure wound therapy (NPWT) technology could be used as a prophylactic measure to&#xD;
      reduce surgical site infections in obese women undergoing cesarean section by immediate&#xD;
      postoperative application in clean-contaminated, closed surgical incisions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity, defined as body mass index (BMI, calculated as weight (kg)/ [height (m)] 2) of 30 or&#xD;
      greater, is a common medical comorbidity of pregnancy affecting one third of&#xD;
      reproductive-aged women. Maternal obesity is also a well-recognized risk factor for&#xD;
      dysfunctional labor and cesarean delivery with a cesarean section rate of 33% in obese women&#xD;
      with BMI of 30 or greater and 43% in women with BMIs of 40 or greater.&#xD;
&#xD;
      Obesity is an independent risk factor for post-operative surgical site infection. The risk of&#xD;
      post-cesarean surgical site infection has been shown to double for every 5 unit increase in&#xD;
      body mass index (BMI) above 30 kg/m , occurring in about 10% of obese women undergoing&#xD;
      caesarean section despite prophylactic strategies (e.g. antibiotics).&#xD;
&#xD;
      This can be explained partly by a decreased blood flow in adipose tissue and an&#xD;
      obesity-associated inflammation causing vascular dysfunction, which results in a local&#xD;
      hypoxic response. Hypoxia impairs oxidative bacterial killing and leads to an increased risk&#xD;
      of surgical site infection.&#xD;
&#xD;
      Wound healing is a sequence of physiologic events that include inflammation,&#xD;
      epithelialization, fibroplasia, and maturation. Failure of wound healing at the surgical site&#xD;
      can lead to seroma, hematoma, wound dehiscence, incisional hernia and surgical site&#xD;
      infection.&#xD;
&#xD;
      Surgical site infection SSI according to The Centers for Disease Control and Prevention is as&#xD;
      an infection occurring within 30 days from the operative procedure in the part of the body&#xD;
      where the surgery took place, where there is purulent drainage from incision, isolated&#xD;
      organisms from the incision, dehiscence or deliberate opening by the surgeon when the patient&#xD;
      has at least one sign or symptom of clinical infection: localized pain, edema, erythema,&#xD;
      warmth and fever greater than 38 c (unless culture of incision is negative) or there is an&#xD;
      abscess or other evidence of infection is found during examination of incision, reoperation,&#xD;
      or pathologic or radiologic exam.&#xD;
&#xD;
      SSIs is divided into incisional SSI and organ/space SSI. Incisional SSI is further divided&#xD;
      into superficial and deep incisional SSI. Superficial Incisional Surgical Site Infection&#xD;
      involves skin or subcutaneous tissue cellulitis, seroma, hematoma, wound healing disruption,&#xD;
      or dehiscence. Deep Incisional Surgical Site Infection involves deep soft tissues such as&#xD;
      fascia or muscle within incision. Organ/Space Surgical Site Infection involves any part of&#xD;
      the anatomy other than the incision. SSI is associated with a maternal mortality rate of up&#xD;
      to 3%.&#xD;
&#xD;
      Wound complication, even if not accompanied by an infection, is a significant cause of&#xD;
      postoperative morbidity following cesarean delivery. In addition to the increased cost of&#xD;
      care, there is the inconvenience of therapy, increased postoperative pain and convalescence,&#xD;
      as well as difficulty with activities of daily living.&#xD;
&#xD;
      It is logical to employ novel risk reducing approaches including negative pressure wound&#xD;
      therapy at the time of surgery that may prevent wound complications and to ensure that there&#xD;
      is a demonstrable benefit to their use for wound complication prophylaxis.&#xD;
&#xD;
      Negative pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC),&#xD;
      involves the controlled application of sub-atmospheric pressure to the local wound&#xD;
      environment, using a sealed wound dressing connected to a vacuum to promote healing by&#xD;
      primary intention by reducing the risk of hematoma / seroma due to improved lymphatic&#xD;
      drainage and reduces the risk of wound dehiscence by decreasing the lateral and shear stress&#xD;
      on sutures and decreasing bacterial load and wound fluids and by increasing blood flow,&#xD;
      oxygenation, angiogenesis, and epithelialization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">February 4, 2021</completion_date>
  <primary_completion_date type="Actual">February 3, 2021</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>Basic information included age, ethnicity, weight, height, body mass index (BMI).&#xD;
Full obstetric, medical and surgical history. Informed written consent will be obtained Patients will receive standard preoperative antibiotic prophylaxis Wound dressing will be applied in a sterile fashion after primary closure of the Pfannenstiel incision closure by interrupted PROLENE Polypropylene Sutures The intervention group: placement of a sterile multilayer dressing (wicking fabric, reticulated foam, and occlusive adhesive). The dressing's tubing will then be attached to a (Yuwell 7E-A portable suction unit) that will deliver 125 mm Hg of continuous pressure to the dressing for 4 days.&#xD;
The comparison group: traditional sterile wound dressing of gauze and tape for 4 days.&#xD;
Post-operative data including: type of dressing used, postoperative hemoglobin, degree of pain, length of hospital stay, readmission for surgical site infection and the type of the surgical site infection.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of wound dehiscence</measure>
    <time_frame>till 30 days post operative</time_frame>
    <description>separation of the incision line prior to complete healing resulting in an open wound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post operative pain</measure>
    <time_frame>till 30 days post operative</time_frame>
    <description>post-operative pain assessed by Wong-Baker Faces pain rating scale,from 0=no pain to 10=maximal pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>till 30 days post operative</time_frame>
    <description>days spent admitted to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the need for re-admission</measure>
    <time_frame>till 30 days post operative</time_frame>
    <description>if the patient encountered surgical site infection requiring re admission to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>further need for additional antibiotics</measure>
    <time_frame>till 30 days post operative</time_frame>
    <description>if the surgical site infection required additional post operative antibiotics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peri-incision blistering</measure>
    <time_frame>till 30 days post operative</time_frame>
    <description>if any skin blistering occurs under the occlusive adhesive layer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient mobility</measure>
    <time_frame>4 days</time_frame>
    <description>if attachment to a negative pressure pump affects patients mobility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical site infection</measure>
    <time_frame>30 days post operative</time_frame>
    <description>as defined by the CDC</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Wound Dehiscence</condition>
  <arm_group>
    <arm_group_label>standard dressing group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients will receive sterile wound dressing of gauze and tape for 4 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>External negative pressure dressing system group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>External negative pressure dressing system (Yuwell 7E-A portable suction unit)</intervention_name>
    <description>A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.</description>
    <arm_group_label>External negative pressure dressing system group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 or older&#xD;
&#xD;
          -  BMI: 30 or greater&#xD;
&#xD;
          -  undergoing Cesarean section through a Pfannenstiel incision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prolonged Rupture of membranes &gt;18 hours&#xD;
&#xD;
          -  Intra amniotic infection&#xD;
&#xD;
          -  Severe anemia&#xD;
&#xD;
          -  Vasculopathies as in hypertension/pre-eclampsia, pregestational / gestational diabetes&#xD;
             mellitus, smoking and substance abuse&#xD;
&#xD;
          -  Prolonged steroids therapy as in SLE, ITP&#xD;
&#xD;
          -  Intraoperative complications as bladder or bowel injury , placenta previa / accreta,&#xD;
             difficult fetal extraction , ovarian cysts, pelvic abscess&#xD;
&#xD;
          -  Intra-abdominal or subcutaneous drain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dalia M Mokhtar, MBBCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>resident of obstetrics and gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marwan O Elkady, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of obstetrics and gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammed S El Sokkary, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of obstetrics and gynecology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AinShams maternity hospital</name>
      <address>
        <city>Cairo</city>
        <state>Al-Waili</state>
        <zip>11658</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7.</citation>
    <PMID>30066454</PMID>
  </reference>
  <reference>
    <citation>Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.</citation>
    <PMID>24056202</PMID>
  </reference>
  <reference>
    <citation>Orth TA, Gerkovich MM, Heitmann E, Overcash J, Gibbs C, Parrish M. Cesarean Delivery with External Negative Pressure Dressing System: A Retrospective Cohort Study. Surg J (N Y). 2016 Jul 20;2(3):e59-e65. doi: 10.1055/s-0036-1585470. eCollection 2016 Jul.</citation>
    <PMID>28824992</PMID>
  </reference>
  <reference>
    <citation>Scalise A, Tartaglione C, Bolletta E, Calamita R, Nicoletti G, Pierangeli M, Grassetti L, Di Benedetto G. The enhanced healing of a high-risk, clean, sutured surgical incision by prophylactic negative pressure wound therapy as delivered by Prevena Customizable: cosmetic and therapeutic results. Int Wound J. 2015 Apr;12(2):218-23. doi: 10.1111/iwj.12370. Epub 2014 Sep 19.</citation>
    <PMID>25234139</PMID>
  </reference>
  <reference>
    <citation>Smid MC, Dotters-Katz SK, Grace M, Wright ST, Villers MS, Hardy-Fairbanks A, Stamilio DM. Prophylactic Negative Pressure Wound Therapy for Obese Women After Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Nov;130(5):969-978. doi: 10.1097/AOG.0000000000002259.</citation>
    <PMID>29016508</PMID>
  </reference>
  <reference>
    <citation>Todd B. New CDC Guideline for the Prevention of Surgical Site Infection. Am J Nurs. 2017 Aug;117(8):17. doi: 10.1097/01.NAJ.0000521963.77728.c0.</citation>
    <PMID>28749874</PMID>
  </reference>
  <reference>
    <citation>Wells CI, Ratnayake CBB, Perrin J, Pandanaboyana S. Prophylactic Negative Pressure Wound Therapy in Closed Abdominal Incisions: A Meta-analysis of Randomised Controlled Trials. World J Surg. 2019 Nov;43(11):2779-2788. doi: 10.1007/s00268-019-05116-6.</citation>
    <PMID>31396673</PMID>
  </reference>
  <reference>
    <citation>Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.</citation>
    <PMID>28255256</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Dalia Magdy Mokhtar</investigator_full_name>
    <investigator_title>resident of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>wound dehiscence</keyword>
  <keyword>obesity</keyword>
  <keyword>negative pressure therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>patient's age ,ethnicity,gravidity,parity,gestational age ,previous cesarean section, previous surgeries,weight, height,BMI,pre/post operative haemoglobin,degree of post operative pain,incidence and type of surgical site infection,length of hospital stay, need for re-admission,need for additional antibiotics</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>after completing the study and henceforth .</ipd_time_frame>
    <ipd_access_criteria>everyone can review the IPD on this site for any type of analysis they desire .</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04434820
org study id: 642357
nct id: NCT04434820
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Obesity is associated with increased cesarean section delivery rates and surgical site
      infections with associated increased post-operative morbidity, post-operative pain and length
      of hospital stay.

      Negative pressure wound therapy (NPWT) technology could be used as a prophylactic measure to
      reduce surgical site infections in obese women undergoing cesarean section by immediate
      postoperative application in clean-contaminated, closed surgical incisions.
Obesity, defined as body mass index (BMI, calculated as weight (kg)/ [height (m)] 2) of 30 or
      greater, is a common medical comorbidity of pregnancy affecting one third of
      reproductive-aged women. Maternal obesity is also a well-recognized risk factor for
      dysfunctional labor and cesarean delivery with a cesarean section rate of 33% in obese women
      with BMI of 30 or greater and 43% in women with BMIs of 40 or greater.

      Obesity is an independent risk factor for post-operative surgical site infection. The risk of
      post-cesarean surgical site infection has been shown to double for every 5 unit increase in
      body mass index (BMI) above 30 kg/m , occurring in about 10% of obese women undergoing
      caesarean section despite prophylactic strategies (e.g. antibiotics).

      This can be explained partly by a decreased blood flow in adipose tissue and an
      obesity-associated inflammation causing vascular dysfunction, which results in a local
      hypoxic response. Hypoxia impairs oxidative bacterial killing and leads to an increased risk
      of surgical site infection.

      Wound healing is a sequence of physiologic events that include inflammation,
      epithelialization, fibroplasia, and maturation. Failure of wound healing at the surgical site
      can lead to seroma, hematoma, wound dehiscence, incisional hernia and surgical site
      infection.

      Surgical site infection SSI according to The Centers for Disease Control and Prevention is as
      an infection occurring within 30 days from the operative procedure in the part of the body
      where the surgery took place, where there is purulent drainage from incision, isolated
      organisms from the incision, dehiscence or deliberate opening by the surgeon when the patient
      has at least one sign or symptom of clinical infection: localized pain, edema, erythema,
      warmth and fever greater than 38 c (unless culture of incision is negative) or there is an
      abscess or other evidence of infection is found during examination of incision, reoperation,
      or pathologic or radiologic exam.

      SSIs is divided into incisional SSI and organ/space SSI. Incisional SSI is further divided
      into superficial and deep incisional SSI. Superficial Incisional Surgical Site Infection
      involves skin or subcutaneous tissue cellulitis, seroma, hematoma, wound healing disruption,
      or dehiscence. Deep Incisional Surgical Site Infection involves deep soft tissues such as
      fascia or muscle within incision. Organ/Space Surgical Site Infection involves any part of
      the anatomy other than the incision. SSI is associated with a maternal mortality rate of up
      to 3%.

      Wound complication, even if not accompanied by an infection, is a significant cause of
      postoperative morbidity following cesarean delivery. In addition to the increased cost of
      care, there is the inconvenience of therapy, increased postoperative pain and convalescence,
      as well as difficulty with activities of daily living.

      It is logical to employ novel risk reducing approaches including negative pressure wound
      therapy at the time of surgery that may prevent wound complications and to ensure that there
      is a demonstrable benefit to their use for wound complication prophylaxis.

      Negative pressure wound therapy (NPWT), also known as a vacuum assisted closure (VAC),
      involves the controlled application of sub-atmospheric pressure to the local wound
      environment, using a sealed wound dressing connected to a vacuum to promote healing by
      primary intention by reducing the risk of hematoma / seroma due to improved lymphatic
      drainage and reduces the risk of wound dehiscence by decreasing the lateral and shear stress
      on sutures and decreasing bacterial load and wound fluids and by increasing blood flow,
      oxygenation, angiogenesis, and epithelialization.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Basic information included age, ethnicity, weight, height, body mass index (BMI).
Full obstetric, medical and surgical history. Informed written consent will be obtained Patients will receive standard preoperative antibiotic prophylaxis Wound dressing will be applied in a sterile fashion after primary closure of the Pfannenstiel incision closure by interrupted PROLENE Polypropylene Sutures The intervention group: placement of a sterile multilayer dressing (wicking fabric, reticulated foam, and occlusive adhesive). The dressing's tubing will then be attached to a (Yuwell 7E-A portable suction unit) that will deliver 125 mm Hg of continuous pressure to the dressing for 4 days.
The comparison group: traditional sterile wound dressing of gauze and tape for 4 days.
Post-operative data including: type of dressing used, postoperative hemoglobin, degree of pain, length of hospital stay, readmission for surgical site infection and the type of the surgical site infection.
primary purpose: Prevention
masking: None (Open Label)
measure: incidence of wound dehiscence
time frame: till 30 days post operative
description: separation of the incision line prior to complete healing resulting in an open wound.
measure: post operative pain
time frame: till 30 days post operative
description: post-operative pain assessed by Wong-Baker Faces pain rating scale,from 0=no pain to 10=maximal pain
measure: length of hospital stay
time frame: till 30 days post operative
description: days spent admitted to the hospital
measure: the need for re-admission
time frame: till 30 days post operative
description: if the patient encountered surgical site infection requiring re admission to the hospital
measure: further need for additional antibiotics
time frame: till 30 days post operative
description: if the surgical site infection required additional post operative antibiotics
measure: peri-incision blistering
time frame: till 30 days post operative
description: if any skin blistering occurs under the occlusive adhesive layer
measure: patient mobility
time frame: 4 days
description: if attachment to a negative pressure pump affects patients mobility
measure: surgical site infection
time frame: 30 days post operative
description: as defined by the CDC
arm group label: standard dressing group
arm group type: No Intervention
description: patients will receive sterile wound dressing of gauze and tape for 4 days.
arm group label: External negative pressure dressing system group
arm group type: Active Comparator
description: patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.
intervention type: Device
intervention name: External negative pressure dressing system (Yuwell 7E-A portable suction unit)
description: A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.
arm group label: External negative pressure dressing system group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dalia M Mokhtar, MBBCh
role: Principal Investigator
affiliation: resident of obstetrics and gynecology
last name: Marwan O Elkady, MD
role: Study Director
affiliation: Lecturer of obstetrics and gynecology
last name: Mohammed S El Sokkary, MD
role: Study Chair
affiliation: Professor of obstetrics and gynecology
facility: 
country: Egypt
citation: Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7.
PMID: 30066454
citation: Mark KS, Alger L, Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: a pilot study. Surg Innov. 2014 Aug;21(4):345-9. doi: 10.1177/1553350613503736. Epub 2013 Sep 20.
PMID: 24056202
citation: Orth TA, Gerkovich MM, Heitmann E, Overcash J, Gibbs C, Parrish M. Cesarean Delivery with External Negative Pressure Dressing System: A Retrospective Cohort Study. Surg J (N Y). 2016 Jul 20;2(3):e59-e65. doi: 10.1055/s-0036-1585470. eCollection 2016 Jul.
PMID: 28824992
citation: Scalise A, Tartaglione C, Bolletta E, Calamita R, Nicoletti G, Pierangeli M, Grassetti L, Di Benedetto G. The enhanced healing of a high-risk, clean, sutured surgical incision by prophylactic negative pressure wound therapy as delivered by Prevena Customizable: cosmetic and therapeutic results. Int Wound J. 2015 Apr;12(2):218-23. doi: 10.1111/iwj.12370. Epub 2014 Sep 19.
PMID: 25234139
citation: Smid MC, Dotters-Katz SK, Grace M, Wright ST, Villers MS, Hardy-Fairbanks A, Stamilio DM. Prophylactic Negative Pressure Wound Therapy for Obese Women After Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Nov;130(5):969-978. doi: 10.1097/AOG.0000000000002259.
PMID: 29016508
citation: Todd B. New CDC Guideline for the Prevention of Surgical Site Infection. Am J Nurs. 2017 Aug;117(8):17. doi: 10.1097/01.NAJ.0000521963.77728.c0.
PMID: 28749874
citation: Wells CI, Ratnayake CBB, Perrin J, Pandanaboyana S. Prophylactic Negative Pressure Wound Therapy in Closed Abdominal Incisions: A Meta-analysis of Randomised Controlled Trials. World J Surg. 2019 Nov;43(11):2779-2788. doi: 10.1007/s00268-019-05116-6.
PMID: 31396673
citation: Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
PMID: 28255256
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Dalia Magdy Mokhtar
investigator title: resident of obstetrics and gynecology
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: patient's age ,ethnicity,gravidity,parity,gestational age ,previous cesarean section, previous surgeries,weight, height,BMI,pre/post operative haemoglobin,degree of post operative pain,incidence and type of surgical site infection,length of hospital stay, need for re-admission,need for additional antibiotics
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: after completing the study and henceforth .
ipd access criteria: everyone can review the IPD on this site for any type of analysis they desire .