<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/NCT04480684</url>
  </required_header>
  <id_info>
    <org_study_id>278466</org_study_id>
    <nct_id>NCT04480684</nct_id>
  </id_info>
  <brief_title>The Effect of Perineal Wound Infection on the Anal Sphincter</brief_title>
  <official_title>A Prospective Observational Study Evaluating the Sonographic Appearance of the Anal Sphincter in Women With Perineal Wound Infection Following Vaginal Delivery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Croydon Health Services NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Croydon Health Services NHS Trust</source>
  <oversight_info>
    <has_dmc>No</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>
      Perineal injury following childbirth can result in complications such as wound infection. The&#xD;
      perineum has closely related anatomical structures including the external genital organs and&#xD;
      the anal triangle which contains the anal sphincter muscles. Therefore as wound infection can&#xD;
      extend and as muscles of the perineum sit in such close proximity to each other, the anal&#xD;
      sphincter muscles could potentially be affected. This could also potentially include cases of&#xD;
      perineal injury where the anal sphincter was not injured.&#xD;
&#xD;
      However ultrasound has never been used to investigate this. Endoanal ultrasound is the gold&#xD;
      standard diagnostic tool in the assessment of obstetric anal sphincter injury. The anal&#xD;
      sphincter can also be visualised using multiplanar transperineal&#xD;
      ultrasound(three/four-dimensional. Therefore both modalities could be used. However, it has&#xD;
      been shown that transperineal ultrasound has a high positive predictive value and therefore&#xD;
      is able to correctly identify an intact anal sphincter, but low positive predictive value;&#xD;
      meaning poor detection of sphincter defects. Therefore, although it cannot completely&#xD;
      substitute endoanal ultrasound (the gold standard in investigating obstetric anal sphincter&#xD;
      injuries), it provides and adjunct/alternative for women who cannot tolerate endoanal&#xD;
      ultrasound.&#xD;
&#xD;
      The investigators plan to perform an observational study to evaluate to the natural history&#xD;
      of perineal wound infections. Patients will be assessed weekly with endoanal ultrasound&#xD;
      and/or transperineal ultrasound until the wound infection has resolved and the wound has&#xD;
      clinically healed.&#xD;
&#xD;
      If a bacterial wound swab has not been taken prior to recruitment or wound swab results are&#xD;
      not available, one will be taken to detect the causative organisms. Appropriate antibiotics&#xD;
      will then be given to cover the detected organism.&#xD;
&#xD;
      Bacterial burden and will also be measured weekly using the MolecuLight i:X; a bacterial&#xD;
      autofluorescence camera which captures the presence and load of bacteria.&#xD;
&#xD;
      In wounds that have superficially dehisced; exact wound measurements including wound surface&#xD;
      area, depth, volume and healing progress will be precisely measured using the Silhouette® 3D&#xD;
      camera&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">August 14, 2021</completion_date>
  <primary_completion_date type="Actual">August 14, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sphincter defect 3-point radial angle</measure>
    <time_frame>Baseline until wound infection resolved and wound healed, or up to 16 weeks</time_frame>
    <description>Endoanal ultrasound and/or transperineal ultrasound will be performed to assess involvement of the anal sphincter.&#xD;
Anal sphincter defects will measured on both modalities with a 3-point angle, with the angle vertex in the middle of the anal canal. The 3D volume will be assessed at the deep, superficial, and subcutaneous levels for defects. A change in radial angle size will be measured.&#xD;
On transperineal ultrasound the extent of the defect will be measured circumferentially using a 3-point radial angle(0 degrees being no defect). A change in radial angle size will be measured.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sphincter defect Stark Score</measure>
    <time_frame>Baseline until wound infection resolved and wound healed, or up to 16 weeks</time_frame>
    <description>On endoanal ultrasound, anal sphincter defects will also be scored using a validated Starck score which accounts for depth, length and size of the defect for both internal and external anal sphincter, with a range from 0 being no defect to 16 being maximal defect. Therefore, a change in this score will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in bacterial fluorescence patterns</measure>
    <time_frame>Baseline until wound infection resolved and wound healed, or up to 16 weeks</time_frame>
    <description>The bacterial load of the perineal wound will be measured every week using the MolecuLight i:X. This is a system, which uses fluorescent illumination to capture and document the presence of bacteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in wound dimensions</measure>
    <time_frame>Baseline until wound infection resolved and wound healed, or up to 16 weeks</time_frame>
    <description>Change in total wound size using the Silhouette® 3D camera.</description>
  </secondary_outcome>
  <enrollment type="Actual">80</enrollment>
  <condition>Obstetric Trauma</condition>
  <condition>Perineum; Injury</condition>
  <condition>Perineal Infection</condition>
  <condition>Anal Sphincter Injury</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Three-dimensional Endoanal Ultrasound</intervention_name>
    <description>Three-dimensional endoanal ultrasound is the gold standard diagnostic tool in the assessment of obstetric anal sphincter injury. The anorectal transducer is inserted directly into the anal canal which allows assessment of the anal sphincter complex.&#xD;
Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transperineal Ultrasound(multiplanar)</intervention_name>
    <description>If endoanal ultrasound is declined or not tolerated, the anal sphincter will also be assessed using three-/four-dimensional (3D/4D) transperineal ultrasound with the probe placed externally on the area of the fourchette.&#xD;
Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.</description>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>The MolecuLight i:X: Bacterial autofluorescence camera</intervention_name>
    <description>The bacterial load of the perineal wound will be measured every week using the MolecuLight i:X. This is a system, which uses fluorescent illumination to capture and document the presence of bacteria.&#xD;
Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.&#xD;
These findings will be supported by microbiological analysis of the wound fluid with swab culture and sensitivity.</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Silhouette® 3D camera: Three-dimensional wound measuring camera</intervention_name>
    <description>For wound that have superficially dehisced, the wound surface area, depth, volume and healing progress will be precisely measured using the Silhouette® 3D camera. This is a system that uses 3D laser technology to track wound healing progression.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who have been referred to the Croydon University Hospital dedicated perineal&#xD;
        clinic with perineal wound infection will be invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with childbirth related perineal injury and wound infection&#xD;
&#xD;
          -  Women over 18 years of age&#xD;
&#xD;
          -  Ability to understand and read the patient information sheet (in English)&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable Adult&#xD;
&#xD;
          -  Fetal or neonatal death or poor neonatal outcome&#xD;
&#xD;
          -  Women who are in an immunosuppressive state (e.g human immunodeficiency virus or&#xD;
             pharmacologically induced immunodeficiencies by chemotherapy or steroids)&#xD;
&#xD;
          -  Inability to give consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdul H Sultan, MB.ChB, MD, FRCOG</last_name>
    <role>Principal Investigator</role>
    <affiliation>Croydon Health Services NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Croydon University Hospital</name>
      <address>
        <city>London</city>
        <zip>CR7 7YE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>McCandlish R, Bowler U, van Asten H, Berridge G, Winter C, Sames L, Garcia J, Renfrew M, Elbourne D. A randomised controlled trial of care of the perineum during second stage of normal labour. Br J Obstet Gynaecol. 1998 Dec;105(12):1262-72. doi: 10.1111/j.1471-0528.1998.tb10004.x.</citation>
    <PMID>9883917</PMID>
  </reference>
  <reference>
    <citation>Royal College of Obstetricians and Gynaecologists (RCOG). Methods and Materials used in Perineal repair, Guideline No 23. London: Royal College of Obstetricians and Gynaecologists Press; 2004.</citation>
  </reference>
  <reference>
    <citation>Thakar R, Fenner DE. Anatomy of the Perineum and the Anal Sphincter. In: Sultan AH, Thakar R, Fenner DE, editors. Perineal and Anal Sphincter Trauma: Diagnosis and Clinical Management [Internet]. London: Springer London; 2007. p. 1-12. Available from: https://doi.org/10.1007/978-1-84628-503-5_1</citation>
  </reference>
  <reference>
    <citation>Sultan AH. Obstetric Perineal Injury and Anal Incontinence. AVMA Medical &amp; Legal Journal. 1999 Nov;5(6):193-6</citation>
  </reference>
  <reference>
    <citation>Webb S, Sherburn M, Ismail KM. Managing perineal trauma after childbirth. BMJ. 2014 Nov 25;349:g6829. doi: 10.1136/bmj.g6829. No abstract available.</citation>
    <PMID>25425212</PMID>
  </reference>
  <reference>
    <citation>Arendsen L, Thakar R, Sultan A. Can perineal wound infection following vagina delivery be reduced? A double blind randomised controlled trial using copper impregnated maternity sanitary towels. European Journal of Obstetrics &amp; Gynecology and Reproductive Biology. 2019 Mar;234:e180.</citation>
  </reference>
  <reference>
    <citation>Taithongchai A, van Gruting IMA, Volloyhaug I, Arendsen LP, Sultan AH, Thakar R. Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries. Am J Obstet Gynecol. 2019 Aug;221(2):134.e1-134.e9. doi: 10.1016/j.ajog.2019.04.009. Epub 2019 Apr 11.</citation>
    <PMID>30981717</PMID>
  </reference>
  <reference>
    <citation>European Centre for Disease Prevention and Control. Stockholm. Surgical site infections. In:ECDC. Annual epidemiological report for 2017. 2019.</citation>
  </reference>
  <reference>
    <citation>Sultan AH, Kamm MA. Faecal incontinence after childbirth. Br J Obstet Gynaecol. 1997 Sep;104(9):979-82. doi: 10.1111/j.1471-0528.1997.tb12052.x. No abstract available.</citation>
    <PMID>9307520</PMID>
  </reference>
  <reference>
    <citation>National Healthcare Safety Network, Centers for Disease Control and Prevention. Surgical site infection (SSI) event. [Internet]. 2017. Available from: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.</citation>
  </reference>
  <reference>
    <citation>Eisenberg VH, Valsky DV, Yagel S. Transperineal ultrasound assessment of the anal sphincter after obstetric anal sphincter injury (OASI). Ultrasound Obstet Gynecol. 2019 Feb;53(2):158-165. doi: 10.1002/uog.19058. No abstract available.</citation>
    <PMID>29575180</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Croydon Health Services NHS Trust</investigator_affiliation>
    <investigator_full_name>Mr Abdul H Sultan</investigator_full_name>
    <investigator_title>Consultant Obstetrician &amp; Gynaecologist</investigator_title>
  </responsible_party>
  <keyword>Obstetric Anal Sphincter Injury</keyword>
  <keyword>Childbirth related perineal trauma</keyword>
  <keyword>Perineal wound infection</keyword>
  <keyword>Endoanal ultrasound</keyword>
  <keyword>Transperineal ultrasound</keyword>
  <keyword>3D Ultrasound</keyword>
  <keyword>4D Ultrasound</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>Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04480684/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT04480684/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04480684
org study id: 278466
nct id: NCT04480684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perineal injury following childbirth can result in complications such as wound infection. The
      perineum has closely related anatomical structures including the external genital organs and
      the anal triangle which contains the anal sphincter muscles. Therefore as wound infection can
      extend and as muscles of the perineum sit in such close proximity to each other, the anal
      sphincter muscles could potentially be affected. This could also potentially include cases of
      perineal injury where the anal sphincter was not injured.

      However ultrasound has never been used to investigate this. Endoanal ultrasound is the gold
      standard diagnostic tool in the assessment of obstetric anal sphincter injury. The anal
      sphincter can also be visualised using multiplanar transperineal
      ultrasound(three/four-dimensional. Therefore both modalities could be used. However, it has
      been shown that transperineal ultrasound has a high positive predictive value and therefore
      is able to correctly identify an intact anal sphincter, but low positive predictive value;
      meaning poor detection of sphincter defects. Therefore, although it cannot completely
      substitute endoanal ultrasound (the gold standard in investigating obstetric anal sphincter
      injuries), it provides and adjunct/alternative for women who cannot tolerate endoanal
      ultrasound.

      The investigators plan to perform an observational study to evaluate to the natural history
      of perineal wound infections. Patients will be assessed weekly with endoanal ultrasound
      and/or transperineal ultrasound until the wound infection has resolved and the wound has
      clinically healed.

      If a bacterial wound swab has not been taken prior to recruitment or wound swab results are
      not available, one will be taken to detect the causative organisms. Appropriate antibiotics
      will then be given to cover the detected organism.

      Bacterial burden and will also be measured weekly using the MolecuLight i:X; a bacterial
      autofluorescence camera which captures the presence and load of bacteria.

      In wounds that have superficially dehisced; exact wound measurements including wound surface
      area, depth, volume and healing progress will be precisely measured using the Silhouette® 3D
      camera
observational model: Cohort
time perspective: Prospective
measure: Change in sphincter defect 3-point radial angle
time frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
description: Endoanal ultrasound and/or transperineal ultrasound will be performed to assess involvement of the anal sphincter.
Anal sphincter defects will measured on both modalities with a 3-point angle, with the angle vertex in the middle of the anal canal. The 3D volume will be assessed at the deep, superficial, and subcutaneous levels for defects. A change in radial angle size will be measured.
On transperineal ultrasound the extent of the defect will be measured circumferentially using a 3-point radial angle(0 degrees being no defect). A change in radial angle size will be measured.
measure: Change in sphincter defect Stark Score
time frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
description: On endoanal ultrasound, anal sphincter defects will also be scored using a validated Starck score which accounts for depth, length and size of the defect for both internal and external anal sphincter, with a range from 0 being no defect to 16 being maximal defect. Therefore, a change in this score will be measured.
measure: Change in bacterial fluorescence patterns
time frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
description: The bacterial load of the perineal wound will be measured every week using the MolecuLight i:X. This is a system, which uses fluorescent illumination to capture and document the presence of bacteria.
measure: Change in wound dimensions
time frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
description: Change in total wound size using the Silhouette® 3D camera.
intervention type: Diagnostic Test
intervention name: Three-dimensional Endoanal Ultrasound
description: Three-dimensional endoanal ultrasound is the gold standard diagnostic tool in the assessment of obstetric anal sphincter injury. The anorectal transducer is inserted directly into the anal canal which allows assessment of the anal sphincter complex.
Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.
intervention type: Diagnostic Test
intervention name: Transperineal Ultrasound(multiplanar)
description: If endoanal ultrasound is declined or not tolerated, the anal sphincter will also be assessed using three-/four-dimensional (3D/4D) transperineal ultrasound with the probe placed externally on the area of the fourchette.
Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.
intervention type: Diagnostic Test
intervention name: The MolecuLight i:X: Bacterial autofluorescence camera
description: The bacterial load of the perineal wound will be measured every week using the MolecuLight i:X. This is a system, which uses fluorescent illumination to capture and document the presence of bacteria.
Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.
These findings will be supported by microbiological analysis of the wound fluid with swab culture and sensitivity.
intervention type: Device
intervention name: Silhouette® 3D camera: Three-dimensional wound measuring camera
description: For wound that have superficially dehisced, the wound surface area, depth, volume and healing progress will be precisely measured using the Silhouette® 3D camera. This is a system that uses 3D laser technology to track wound healing progression.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abdul H Sultan, MB.ChB, MD, FRCOG
role: Principal Investigator
affiliation: Croydon Health Services NHS Trust
facility: 
country: United Kingdom
citation: McCandlish R, Bowler U, van Asten H, Berridge G, Winter C, Sames L, Garcia J, Renfrew M, Elbourne D. A randomised controlled trial of care of the perineum during second stage of normal labour. Br J Obstet Gynaecol. 1998 Dec;105(12):1262-72. doi: 10.1111/j.1471-0528.1998.tb10004.x.
PMID: 9883917
citation: Royal College of Obstetricians and Gynaecologists (RCOG). Methods and Materials used in Perineal repair, Guideline No 23. London: Royal College of Obstetricians and Gynaecologists Press; 2004.
citation: Thakar R, Fenner DE. Anatomy of the Perineum and the Anal Sphincter. In: Sultan AH, Thakar R, Fenner DE, editors. Perineal and Anal Sphincter Trauma: Diagnosis and Clinical Management [Internet]. London: Springer London; 2007. p. 1-12. Available from: https://doi.org/10.1007/978-1-84628-503-5_1
citation: Sultan AH. Obstetric Perineal Injury and Anal Incontinence. AVMA Medical & Legal Journal. 1999 Nov;5(6):193-6
citation: Webb S, Sherburn M, Ismail KM. Managing perineal trauma after childbirth. BMJ. 2014 Nov 25;349:g6829. doi: 10.1136/bmj.g6829. No abstract available.
PMID: 25425212
citation: Arendsen L, Thakar R, Sultan A. Can perineal wound infection following vagina delivery be reduced? A double blind randomised controlled trial using copper impregnated maternity sanitary towels. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2019 Mar;234:e180.
citation: Taithongchai A, van Gruting IMA, Volloyhaug I, Arendsen LP, Sultan AH, Thakar R. Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries. Am J Obstet Gynecol. 2019 Aug;221(2):134.e1-134.e9. doi: 10.1016/j.ajog.2019.04.009. Epub 2019 Apr 11.
PMID: 30981717
citation: European Centre for Disease Prevention and Control. Stockholm. Surgical site infections. In:ECDC. Annual epidemiological report for 2017. 2019.
citation: Sultan AH, Kamm MA. Faecal incontinence after childbirth. Br J Obstet Gynaecol. 1997 Sep;104(9):979-82. doi: 10.1111/j.1471-0528.1997.tb12052.x. No abstract available.
PMID: 9307520
citation: National Healthcare Safety Network, Centers for Disease Control and Prevention. Surgical site infection (SSI) event. [Internet]. 2017. Available from: http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf.
citation: Eisenberg VH, Valsky DV, Yagel S. Transperineal ultrasound assessment of the anal sphincter after obstetric anal sphincter injury (OASI). Ultrasound Obstet Gynecol. 2019 Feb;53(2):158-165. doi: 10.1002/uog.19058. No abstract available.
PMID: 29575180
responsible party type: Principal Investigator
investigator affiliation: Croydon Health Services NHS Trust
investigator full name: Mr Abdul H Sultan
investigator title: Consultant Obstetrician & Gynaecologist
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Wound Infection
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 
provided document: 