The Effect of Perineal Wound Infection on the Anal Sphincter

CompletedOBSERVATIONAL
Enrollment

80

Participants

Timeline

Start Date

August 14, 2020

Primary Completion Date

August 14, 2021

Study Completion Date

August 14, 2021

Conditions
Obstetric TraumaPerineum; InjuryPerineal InfectionAnal Sphincter Injury
Interventions
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.

Trial Locations (1)

CR7 7YE

Croydon University Hospital, London

All Listed Sponsors
lead

Croydon Health Services NHS Trust

OTHER

NCT04480684 - The Effect of Perineal Wound Infection on the Anal Sphincter | Biotech Hunter | Biotech Hunter