The Effect of Perineal Wound Infection on the Anal Sphincter

• ClinicalTrials.gov Identifier: NCT04480684
• Recruitment Status: Completed
• First Posted: July 21, 2020
• Last Update Posted: September 16, 2021
• Sponsor: Croydon Health Services NHS Trust
• Information provided by (Responsible Party): Mr Abdul H Sultan, Croydon Health Services NHS Trust

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Obstetric Trauma; Perineum; Injury; Perineal Infection; Anal Sphincter Injury	Diagnostic Test: Three-dimensional Endoanal Ultrasound; Diagnostic Test: Transperineal Ultrasound(multiplanar); Diagnostic Test: The MolecuLight i:X: Bacterial autofluorescence camera; Device: Silhouette® 3D camera: Three-dimensional wound measuring camera

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Observational Study Evaluating the Sonographic Appearance of the Anal Sphincter in Women With Perineal Wound Infection Following Vaginal Delivery.
• Actual Study Start Date: August 14, 2020
• Actual Primary Completion Date: August 14, 2021
• Actual Study Completion Date: August 14, 2021

Groups and Cohorts

Intervention Details:

• Diagnostic Test: Three-dimensional Endoanal Ultrasound

  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.

• Diagnostic Test: Transperineal Ultrasound(multiplanar)

  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.

• Diagnostic Test: The MolecuLight i:X: Bacterial autofluorescence camera

  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.

• Device: Silhouette® 3D camera: Three-dimensional wound measuring camera
  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.

Outcome Measures

Primary Outcome Measures :

1. Change in sphincter defect 3-point radial angle [ Time Frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks ]

   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.

2. Change in sphincter defect Stark Score [ Time Frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks ]
   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.

Secondary Outcome Measures :

1. Change in bacterial fluorescence patterns [ Time Frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks ]
   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.
2. Change in wound dimensions [ Time Frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks ]
   Change in total wound size using the Silhouette® 3D camera.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

All patients who have been referred to the Croydon University Hospital dedicated perineal clinic with perineal wound infection will be invited to participate.

Criteria

Inclusion Criteria:

• Women with childbirth related perineal injury and wound infection
• Women over 18 years of age
• Ability to understand and read the patient information sheet (in English)
• Ability to give informed consent

Exclusion Criteria:

• Vulnerable Adult
• Fetal or neonatal death or poor neonatal outcome
• Women who are in an immunosuppressive state (e.g human immunodeficiency virus or pharmacologically induced immunodeficiencies by chemotherapy or steroids)
• Inability to give consent

Contacts and Locations

Locations

United Kingdom

Croydon University Hospital

London, United Kingdom, CR7 7YE

Sponsors and Collaborators

Croydon Health Services NHS Trust

Investigators

• Principal Investigator: Abdul H Sultan, MB.ChB, MD, FRCOG; Croydon Health Services NHS Trust

  Study Documents (Full-Text)

Documents provided by Mr Abdul H Sultan, Croydon Health Services NHS Trust:

Study Protocol and Statistical Analysis Plan  [PDF] June 10, 2020

Informed Consent Form  [PDF] June 8, 2020

More Information

Publications:

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.

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.

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

Sultan AH. Obstetric Perineal Injury and Anal Incontinence. AVMA Medical & Legal Journal. 1999 Nov;5(6):193-6

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.

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.

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.

European Centre for Disease Prevention and Control. Stockholm. Surgical site infections. In:ECDC. Annual epidemiological report for 2017. 2019.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Okeahialam NA, Thakar R, Sultan AH. Bacterial autofluorescence in infected perineal wounds: A prospective cohort study. Diagn Microbiol Infect Dis. 2023 Jan;105(1):115831. doi: 10.1016/j.diagmicrobio.2022.115831. Epub 2022 Oct 8.

• Responsible Party: Mr Abdul H Sultan, Consultant Obstetrician & Gynaecologist, Croydon Health Services NHS Trust
• ClinicalTrials.gov Identifier: NCT04480684
• Other Study ID Numbers: 278466
• First Posted: July 21, 2020
• Last Update Posted: September 16, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mr Abdul H Sultan, Croydon Health Services NHS Trust:

Obstetric Anal Sphincter Injury; Childbirth related perineal trauma; Perineal wound infection; Endoanal ultrasound; Transperineal ultrasound; 3D Ultrasound; 4D Ultrasound

Additional relevant MeSH terms:

Infections; Communicable Diseases; Wound Infection; Wounds and Injuries; Disease Attributes; Pathologic Processes