The Effect of Perineal Wound Infection on the Anal Sphincter

September 14, 2021 updated by: Mr Abdul H Sultan, Croydon Health Services NHS Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, CR7 7YE
        • Croydon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sphincter defect 3-point radial angle
Time Frame: 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.
Baseline until wound infection resolved and wound healed, or up to 16 weeks
Change in sphincter defect Stark Score
Time Frame: 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.
Baseline until wound infection resolved and wound healed, or up to 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Croydon Health Services NHS Trust

Investigators

  • Principal Investigator: Abdul H Sultan, MB.ChB, MD, FRCOG, Croydon Health Services NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

August 14, 2021

Study Completion (Actual)

August 14, 2021

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 20, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 278466

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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