The Effect of Perineal Wound Infection on the Anal Sphincter
NCT ID: NCT04480684
Last Updated: 2021-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2020-08-14
2021-08-14
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Women over 18 years of age
* Ability to understand and read the patient information sheet (in English)
* Ability to give informed consent
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Croydon Health Services NHS Trust
OTHER
Responsible Party
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Mr Abdul H Sultan
Consultant Obstetrician & Gynaecologist
Principal Investigators
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Abdul H Sultan, MB.ChB, MD, FRCOG
Role: PRINCIPAL_INVESTIGATOR
Croydon Health Services NHS Trust
Locations
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Croydon University Hospital
London, , United Kingdom
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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278466
Identifier Type: -
Identifier Source: org_study_id
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