Clinical trial NCT04480684: The Effect of Perineal Wound Infection on the Anal Sphincter
Official title: A Prospective Observational Study Evaluating the Sonographic Appearance of the Anal Sphincter in Women With Perineal Wound Infection Following Vaginal Delivery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Trauma
Perineum; Injury
Perineal Infection
Anal Sphincter Injury
Keywords: Obstetric Anal Sphincter Injury
Childbirth related perineal trauma
Perineal wound infection
Endoanal ultrasound
Transperineal ultrasound
3D Ultrasound
4D Ultrasound
Lead sponsor: Croydon Health Services NHS Trust
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: Change in sphincter defect 3-point radial angle
timeFrame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
measure: Change in sphincter defect Stark Score
timeFrame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
Secondary outcomes:
measure: Change in bacterial fluorescence patterns
timeFrame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
measure: Change in wound dimensions
timeFrame: Baseline until wound infection resolved and wound healed, or up to 16 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Croydon University Hospital
Study officials:
affiliation: Croydon Health Services NHS Trust
name: Abdul H Sultan, MB.ChB, MD, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.
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.
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.
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.
citation: 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.