The Effect of Perineal Wound Infection on the Anal Sphincter

Obstetric Trauma Clinical Trial

Official title:

A Prospective Observational Study Evaluating the Sonographic Appearance of the Anal Sphincter in Women With Perineal Wound Infection Following Vaginal Delivery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480684
• Other study ID #: 278466
• Status: Completed
• Start date: August 14, 2020
• Est. completion date: August 14, 2021

Study information

• Verified date: September 2021
• Source: Croydon Health Services NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 14, 2021
• Est. primary completion date: August 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Sphincter Injury
• Communicable Diseases
• Infections
• Obstetric Trauma
• Perineal Infection
• Perineum; Injury
• Wound Infection
• Wounds and Injuries

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
United Kingdom	Croydon University Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Croydon Health Services NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

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.

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. — View Citation

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

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. — View 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.

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.

Sultan AH, Kamm MA. Faecal incontinence after childbirth. Br J Obstet Gynaecol. 1997 Sep;104(9):979-82. — View Citation

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

Taithongchai A, van Gruting IMA, Volløyhaug 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. — View 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

Webb S, Sherburn M, Ismail KM. Managing perineal trauma after childbirth. BMJ. 2014 Nov 25;349:g6829. doi: 10.1136/bmj.g6829. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sphincter defect 3-point radial angle	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.	Baseline until wound infection resolved and wound healed, or up to 16 weeks
Primary	Change in sphincter defect Stark Score	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.	Baseline until wound infection resolved and wound healed, or up to 16 weeks
Secondary	Change in bacterial fluorescence patterns	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.	Baseline until wound infection resolved and wound healed, or up to 16 weeks
Secondary	Change in wound dimensions	Change in total wound size using the Silhouette® 3D camera.	Baseline until wound infection resolved and wound healed, or up to 16 weeks