The Effect of Perineal Wound Infection on the Anal Sphincter

Completed

• Conditions: Perineal Infection; Obstetric Trauma; Perineum; Injury; Anal Sphincter Injury

• Registration Number: NCT04480684
• Lead Sponsor: Croydon Health Services NHS Trust

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-21
• Study Start: 2020-08-14
• Primary Completion: 2021-08-14
• Study Completion: 2021-08-14
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in sphincter defect 3-point radial angle	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.
Change in sphincter defect Stark Score	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

Name	Time	Method
Change in wound dimensions	Baseline until wound infection resolved and wound healed, or up to 16 weeks	Change in total wound size using the Silhouette® 3D camera.
Change in bacterial fluorescence patterns	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.

Trial Locations

Locations (1)

Croydon University Hospital; 🇬🇧 London, United Kingdom