Breast InfectionNCT05762016
Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess
An observational study of Breast Infection, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Conventional techniques for treatment of breast abscess, such as incision and drainage/percutaneous drainage, have disadvantages. Bedside Mini-Incision and Self-Express (MISE) is a novel technique for breast abscess. The outcomes of MISE were compared to the conventional techniques. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Infection
- What is being tested?
- Bedside Mini-Incision and Self-Express (MISE)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2018to 31 Oct 2024
- 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 to 70 years
- Women only
- Adult, Older adult
Study population: females with breast abscess
Who may be able to join
- Patients with a pathologically confirmed breast abscess and
- presenting at KK Women's and Children's Hospital, Singapore
Who cannot join
- mastitis
- granulomatous mastitis
- breast fillers with infection
- ruptured abscess prior to intervention
- other interventions or bilateral breast infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess With the Conventional Techniques: A Retrospective Comparative Cohort Study
Conventional techniques for treatment of breast abscess, such as incision and drainage/percutaneous drainage, have disadvantages. Bedside Mini-Incision and Self-Express (MISE) is a novel technique for breast abscess. The outcomes of MISE were compared to the conventional techniques.
Read the detailed description
outcomes such as recovery time, duration of antibiotics use etc will be compared between the various groups of intervention.
- Conditions
- Breast Infection
- Being tested
- Bedside Mini-Incision and Self-Express (MISE)
- Medical subject headings
- Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside Mini-Incision and Self-Express (MISE)Procedure or surgery
To perform bedside mini incision and encourage patients to self express the pus following the intervention
| Study group | Role | What they receive |
|---|---|---|
| incision and drainage group | patients with breast abscess who undergo incision and drainage | |
| percutaneous drainage group | patients with breast abscess who undergo percutaneous drainage | |
| MISE group | patients with breast abscess who undergo MISE Receives: Procedure: Bedside Mini-Incision and Self-Express (MISE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery time
recovery time for the abscess to resolve
Measured: from diagnosis to date of documented recovery defined as resolution of abscess, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start1 Jan 2018
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast InfectionStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762016
- Sponsor's protocol ID
- CIRB Ref:2021/2634
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess With the Conventional Techniques: A Retrospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT05762016
- Acronym / sponsor ID
- CIRB Ref:2021/2634
- Conditions
- Breast Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 9 Mar 2023 (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.
Conventional techniques for treatment of breast abscess, such as incision and drainage/percutaneous drainage, have disadvantages. Bedside Mini-Incision and Self-Express (MISE) is a novel technique for breast abscess. The outcomes of MISE were compared to the conventional techniques.
Detailed description
outcomes such as recovery time, duration of antibiotics use etc will be compared between the various groups of intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| incision and drainage group | – | –patients with breast abscess who undergo incision and drainage |
| percutaneous drainage group | – | –patients with breast abscess who undergo percutaneous drainage |
| MISE group | – | Procedure: Bedside Mini-Incision and Self-Express (MISE)patients with breast abscess who undergo MISE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- females with breast abscess
Key inclusion criteria (2 listed)
- Patients with a pathologically confirmed breast abscess and
- presenting at KK Women's and Children's Hospital, Singapore
Key exclusion criteria (5 listed)
- mastitis
- granulomatous mastitis
- breast fillers with infection
- ruptured abscess prior to intervention
- other interventions or bilateral breast infection
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 |
|---|---|---|
| Bedside Mini-Incision and Self-Express (MISE)To perform bedside mini incision and encourage patients to self express the pus following the intervention | Procedure or surgery | MISE group |
Primary outcome
recovery time
Time frame: from diagnosis to date of documented recovery defined as resolution of abscess, assessed up to 2 years
recovery time for the abscess to resolve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Infection, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2023. 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 Singapore. 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?
Results are not available in the source record.
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?
recovery time (time frame: from diagnosis to date of documented recovery defined as resolution of abscess, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2023.