Obstetric TraumaNCT04480684
The Effect of Perineal Wound Infection on the Anal Sphincter
An observational study of Obstetric Trauma and Perineum; Injury, run by Croydon Health Services NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Trauma, Perineum; Injury, Perineal Infection
- What is being tested?
- Three-dimensional Endoanal Ultrasound, Transperineal Ultrasound(multiplanar) and The MolecuLight i:X: Bacterial autofluorescence camera
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2020to 14 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Three-dimensional Endoanal Ultrasound, Transperineal Ultrasound(multiplanar), The MolecuLight i:X: Bacterial autofluorescence camera, Silhouette® 3D camera: Three-dimensional wound measuring camera
- Keywords
- Obstetric Anal Sphincter Injury, Childbirth related perineal trauma, Perineal wound infection, Endoanal ultrasound, Transperineal ultrasound, 3D Ultrasound, 4D Ultrasound
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional Endoanal UltrasoundDiagnostic test
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)Diagnostic test
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 cameraDiagnostic test
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.
Silhouette® 3D camera: Three-dimensional wound measuring cameraDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline until wound infection resolved and wound healed, or up to 16 weeks
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.
Measured: Baseline until wound infection resolved and wound healed, or up to 16 weeks
Secondary outcomes (2)
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.
Measured: Baseline until wound infection resolved and wound healed, or up to 16 weeks
Change in wound dimensions
Change in total wound size using the Silhouette® 3D camera.
Measured: Baseline until wound infection resolved and wound healed, or up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start14 Aug 2020
- Primary completion14 Aug 2021
- Study completion14 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Obstetric TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Croydon Health Services NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Abdul H Sultan, Croydon Health Services NHS Trust
- Investigators
- Abdul H Sultan, MB.ChB, MD, FRCOG, Principal investigator, Croydon Health Services NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480684
- Sponsor's protocol ID
- 278466
- Status last verified
- Sep 2021
- First submitted
- 10 Jul 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9883917Royal 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.
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
Sultan AH. Obstetric Perineal Injury and Anal Incontinence. AVMA Medical & Legal Journal. 1999 Nov;5(6):193-6
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.
PubMed 25425212Arendsen 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.
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.
PubMed 30981717European Centre for Disease Prevention and Control. Stockholm. Surgical site infections. In:ECDC. Annual epidemiological report for 2017. 2019.
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.
PubMed 9307520National 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.
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.
PubMed 29575180Okeahialam 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.
PubMed 36332560
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Evaluating the Sonographic Appearance of the Anal Sphincter in Women With Perineal Wound Infection Following Vaginal Delivery.
- ClinicalTrials.gov ID
- NCT04480684
- Acronym / sponsor ID
- 278466
- Keywords
- Obstetric Anal Sphincter Injury, Childbirth related perineal trauma, Perineal wound infection, Endoanal ultrasound, Transperineal ultrasound, 3D Ultrasound, 4D Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Croydon Health Services NHS TrustUniversity, hospital or other
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 14 Aug 2021 (actual)
- Study completion
- 14 Aug 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional Endoanal UltrasoundThree-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 cameraThe 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. | Diagnostic test | – |
| Silhouette® 3D camera: Three-dimensional wound measuring cameraFor 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. | Device | – |
Primary outcome
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.
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.
2 secondary outcomes
Change in bacterial fluorescence patterns
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 9883917McCandlish 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.
- BackgroundRoyal 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.
- BackgroundThakar 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
- BackgroundSultan AH. Obstetric Perineal Injury and Anal Incontinence. AVMA Medical & Legal Journal. 1999 Nov;5(6):193-6
- Background: PubMed 25425212Webb S, Sherburn M, Ismail KM. Managing perineal trauma after childbirth. BMJ. 2014 Nov 25;349:g6829. doi: 10.1136/bmj.g6829. No abstract available.
- BackgroundArendsen 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.
- Background: PubMed 30981717Taithongchai 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.
- BackgroundEuropean Centre for Disease Prevention and Control. Stockholm. Surgical site infections. In:ECDC. Annual epidemiological report for 2017. 2019.
- Background: PubMed 9307520Sultan 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.
- BackgroundNational 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.
- Background: PubMed 29575180Eisenberg 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.
- Derived from this study: PubMed 36332560Okeahialam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul H Sultan, MB.ChB, MD, FRCOG principal investigator
Croydon Health Services NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Trauma and Perineum; Injury, run by Croydon Health Services NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sphincter defect 3-point radial angle (time frame: Baseline until wound infection resolved and wound healed, or up to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480684, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.