- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05762016
Outcomes of a Novel Technique of Mini- Incision and Self-Express (MISE) for Breast Abscess
March 7, 2023 updated by: KK Women's and Children's Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
outcomes such as recovery time, duration of antibiotics use etc will be compared between the various groups of intervention.
Study Type
Observational
Enrollment (Anticipated)
30
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
-
-
-
Singapore, Singapore
- KK Women's and Children's 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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
females with breast abscess
Description
Inclusion Criteria:
- Patients with a pathologically confirmed breast abscess and
- presenting at KK Women's and Children's Hospital, Singapore
Exclusion Criteria: Patients with:
- mastitis
- granulomatous mastitis
- breast fillers with infection
- ruptured abscess prior to intervention
- other interventions or bilateral breast infection
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
To perform bedside mini incision and encourage patients to self express the pus following the intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from diagnosis to date of documented recovery defined as resolution of abscess, assessed up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2018
Primary Completion (Anticipated)
October 31, 2024
Study Completion (Anticipated)
October 31, 2024
Study Registration Dates
First Submitted
February 22, 2023
First Submitted That Met QC Criteria
March 7, 2023
First Posted (Estimate)
March 9, 2023
Study Record Updates
Last Update Posted (Estimate)
March 9, 2023
Last Update Submitted That Met QC Criteria
March 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB Ref:2021/2634
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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