Breast AbscessNCT06594276
Comparison of Efficacy in Treating Breast Abscess, With Systemic Antibiotics Against Local Instillation of Antibiotics Along With Ultrasound Guided Aspiration.
A study testing Local instillation of antibiotics in people with Breast Abscess, run by Gujranwala medical college District Headquarters Hospital, Gujranwala at 1 site in Pakistan.
Trial summary
Breast abscess, marked by localized collection of pus, frequently follows mastitis. Its prevalence soars up to 16% in the developing world. It usually presents in lactating mothers but also develops in prepubertal females as well. Read more about this study
- Who is it for?
- Ages 14 to 60 years, women only
- Conditions the study is for
- Breast Abscess
- What is being tested?
- Local instillation of antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2024to Apr 2025
- Phase
- Interventional
- 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 14 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female gender Age range 14-60 years Lactating or non-lactating Clinical signs : erythema, tenderness, fever, fluctuation
Who cannot join
- Patients refusal Male gender Acute mastitis Malignant lesion (inflammatory carcinoma) Antibioma Draining abscess/Sinus Skin ulcers / gangrene Diagnosed case of Tuberclosis H.I.V
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gujranwala Medical College
Gujranwala, Punjab Province, 52250
Muhammad Noman, +92559201402, gmchospitalgrw@gmail.com
Arslan Anwar
About this study
Official title: Effectiveness of Local Instillation of Antibiotics Compared to Systemic Antibiotics, as Adjunct to Ultrasound Guided Aspiration in the Management of Breast Abscess; a Randomized Controlled Trial
Breast abscess, marked by localized collection of pus, frequently follows mastitis. Its prevalence soars up to 16% in the developing world. It usually presents in lactating mothers but also develops in prepubertal females as well. Conventionally it has been treated by surgical incision and drainage with antibiotic coverage, whether oral, intramuscular or intravenous. This approach requires hospital stay and general anesthesia but also have complications like scarring and disfigurement. With the financial and emotional impacts of this technique , surgeons have opted needle aspiration of breast abscess as a standardized treatment. It has been very successful in the management of breast abscess as it spares the patients from long hospital stays and the cosmetic complications. It may require to repeat the procedure till the complete resolution of symptoms which can be effectively assessed by the clinical symptoms of the patient like redness of the skin, pain, tenderness and ultrasonographical evidence of pus accumulation. Systemic antibiotics are still frequently administered for prophylactic and therapeutic purposes. It has been shown in previous studies that systemic antibiotics may not be as effective as deemed earlier due to local pathogenesis. The use of local antibiotics is not a novel concept but a firmly established fact , whether its the earliest sterilization of the operative field or treating open wounds and fractures . Studies have shown great effect of local use of antibiotics in different scenarios and this may help in limit the use of antibiotics and providing the systemic bypass with maximum local impact. In patients of breast abscess, along with ultrasound guided aspiration the inclusion of locally injecting the antibiotics may reduce the frequency of procedure till the absolute resolution of symptoms and also markedly decrease the failure rate of this technique , which usually resorts to the conventional incision and drainage.
Read the detailed description
A breast abscess is often characterized as a consequence of delayed or insufficient treatment following mastitis. The global prevalence of primary breast abscess in lactating women is estimated to be around 11%. In developing countries, where the quality of life and access to medical care may be limited, the prevalence of breast abscess tends to be higher. For instance, in Pakistan, the occurrence of breast abscess reaches up to 16%.
This condition typically arises due to local inflammation and/or infection of the terminal lactiferous ducts. Mastitis, a precursor to breast abscess, can be attributed to factors such as poor hygiene, inadequate breastfeeding practices, milk stasis, cracked nipples, and the colonization of Staphylococcus aureus. Patients with breast abscess typically present with a painful, tender, and either focally or diffusely swollen breast. It is noteworthy that breast abscesses can be broadly classified into lactational and non-lactational types, each contributing significantly to morbidity in adult women.
Several risk factors contribute to the development of both primary and recurrent lactational breast abscesses. These include increasing maternal age, obesity, primiparity, diabetes, smoking, and a history of mastitis. Additionally, rare predisposing factors encompass breast trauma, duct ectasia, fat necrosis, nipple piercing, and breast cancer.
Staphylococcus aureus remains the most common causative organism, although E. Coli and H. Influenza have also been identified. Of particular concern is the rising prevalence of Methicillin-Resistant Staphylococcus Aureus (MRSA).The traditional approach to managing breast abscesses involves Incision \& Drainage (I\&D) accompanied by antibiotic therapy. However, this method is primarily reserved for complicated cases with skin changes such as ulceration, necrosis, or recurrent abscesses. In recent years, needle aspiration has emerged as the preferred treatment for uncomplicated cases. Clinical examination and radiological assessments using ultrasound or CT are crucial for establishing the diagnosis. Notably, the breast surgery community increasingly adopts needle aspiration as a minimally invasive technique for cases where the abscess size is less than 5cm on ultrasound, and symptoms have persisted for up to 5 days. Needle aspiration offers advantages such as avoiding hospital stays,eliminating the need for general anesthesia, and allowing continued breast feeding. It also reduces the risk of complications like milk fistulae. Factors such as multiple dressings for wound care, pain, dissatisfaction with cosmetic results, and delayed healing with I\&D contribute to the growing acceptance of aspiration as a suitable alternative.
Effective antimicrobial therapy is integral to the treatment of breast abscesses. Post I\&D, antibiotic coverage is mandated for preventing Surgical Site Infection (SSI). The success of aspiration, similarly, hinges on judicious antimicrobial treatment. In an era marked by antibiotic resistance, providing effective and targeted antimicrobial therapy becomes crucial.
Studies highlight the benefits of local instillation of antibiotics, demonstrating promising results in preventing SSIs and managing wounds and abscesses. Local instillation not only provides bypasses systemic administration but also reduces the need for postoperative systemic antibiotics. The concentration of antibiotics at the local site is higher when instilled locally, as evidenced by in vitro studies showing a 100% kill rate after only 60 seconds of exposure to the antibiotic irrigating solution. With advancement and diversity in the field of surgery, it is adapting to minimally invasive procedures with efficient out comes and conserving cosmetics. Aspiration for breast abscesses is replacing the conventional I\&D to provide better care, fewer complications and better cosmetic results. In stemming the rise of resistance patterns antimicrobial stewardship has become surgical obligation. Some studies show that aspiration of the breast abscess with systemic antibiotics has a success rate of up to 94%, around 50%- 60% of the cases are recovered after single aspiration while some 20%-30% required a second time and rest needed multiple aspirations. The use of local instillation of antibiotics adjunct to aspiration in management of breast abscess may help limit the number of aspirations and recurrence, providing better cure and healing time for the patients. Abscess wall and edema makes it take longer to achieve MIC (minimal inhibitory concentration) than the local instillation. It can also help to limit the use of systemic antibiotics, and promote continued breast feeding. Combined they can not only cut down the morbidity but also prove to be better in treating the breast abscess and a key step against the emerging antibiotic resistance.
- Conditions
- Breast Abscess
- Being tested
- Local instillation of antibiotics
- Keywords
- treatment of breast abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local instillation of antibioticsOther
Systemic antibiotics are usually used with needle aspiration of breast abscess. However local instillation of antibiotics will be an in intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Needle aspiration with systemic antibiotics | No intervention | Not described |
| Needle aspiration with local instillation of antibiotics | Active comparator | Not described Receives: Other: Local instillation of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
The number of times the procedure is repeated till the resolution of symptoms
Measured: From enrollment to the end of treatment at 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast AbscessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gujranwala medical college District Headquarters Hospital, Gujranwala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Arslan Anwar, Gujranwala medical college District Headquarters Hospital, Gujranwala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594276
- Sponsor's protocol ID
- 341/GMC -23
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884Barron AU, Luk S, Phelan HA, Williams BH. Do acute-care surgeons follow best practices for breast abscess management? A single-institution analysis of 325 consecutive cases. J Surg Res. 2017 Aug;216:169-171. doi: 10.1016/j.jss.2017.05.013. Epub 2017 May 10.
PubMed 28807202Afridi SP, Alam SN, Ainuddin S. Aspiration of breast abscess through wide bore 14-gauge intravenous cannula. J Coll Physicians Surg Pak. 2014 Oct;24(10):719-21. doi: 10.2014/JCPSP.719721.
PubMed 25327913
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Local Instillation of Antibiotics Compared to Systemic Antibiotics, as Adjunct to Ultrasound Guided Aspiration in the Management of Breast Abscess; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06594276
- Acronym / sponsor ID
- 341/GMC -23
- Conditions
- Breast Abscess
- Keywords
- treatment of breast abscess
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Gujranwala medical college District Headquarters Hospital, GujranwalaUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Breast abscess, marked by localized collection of pus, frequently follows mastitis. Its prevalence soars up to 16% in the developing world. It usually presents in lactating mothers but also develops in prepubertal females as well. Conventionally it has been treated by surgical incision and drainage with antibiotic coverage, whether oral, intramuscular or intravenous. This approach requires hospital stay and general anesthesia but also have complications like scarring and disfigurement. With the financial and emotional impacts of this technique , surgeons have opted needle aspiration of breast abscess as a standardized treatment. It has been very successful in the management of breast abscess as it spares the patients from long hospital stays and the cosmetic complications. It may require to repeat the procedure till the complete resolution of symptoms which can be effectively assessed by the clinical symptoms of the patient like redness of the skin, pain, tenderness and ultrasonographical evidence of pus accumulation. Systemic antibiotics are still frequently administered for prophylactic and therapeutic purposes. It has been shown in previous studies that systemic antibiotics may not be as effective as deemed earlier due to local pathogenesis. The use of local antibiotics is not a novel concept but a firmly established fact , whether its the earliest sterilization of the operative field or treating open wounds and fractures . Studies have shown great effect of local use of antibiotics in different scenarios and this may help in limit the use of antibiotics and providing the systemic bypass with maximum local impact. In patients of breast abscess, along with ultrasound guided aspiration the inclusion of locally injecting the antibiotics may reduce the frequency of procedure till the absolute resolution of symptoms and also markedly decrease the failure rate of this technique , which usually resorts to the conventional incision and drainage.
Detailed description
A breast abscess is often characterized as a consequence of delayed or insufficient treatment following mastitis. The global prevalence of primary breast abscess in lactating women is estimated to be around 11%. In developing countries, where the quality of life and access to medical care may be limited, the prevalence of breast abscess tends to be higher. For instance, in Pakistan, the occurrence of breast abscess reaches up to 16%.
This condition typically arises due to local inflammation and/or infection of the terminal lactiferous ducts. Mastitis, a precursor to breast abscess, can be attributed to factors such as poor hygiene, inadequate breastfeeding practices, milk stasis, cracked nipples, and the colonization of Staphylococcus aureus. Patients with breast abscess typically present with a painful, tender, and either focally or diffusely swollen breast. It is noteworthy that breast abscesses can be broadly classified into lactational and non-lactational types, each contributing significantly to morbidity in adult women.
Several risk factors contribute to the development of both primary and recurrent lactational breast abscesses. These include increasing maternal age, obesity, primiparity, diabetes, smoking, and a history of mastitis. Additionally, rare predisposing factors encompass breast trauma, duct ectasia, fat necrosis, nipple piercing, and breast cancer.
Staphylococcus aureus remains the most common causative organism, although E. Coli and H. Influenza have also been identified. Of particular concern is the rising prevalence of Methicillin-Resistant Staphylococcus Aureus (MRSA).The traditional approach to managing breast abscesses involves Incision \& Drainage (I\&D) accompanied by antibiotic therapy. However, this method is primarily reserved for complicated cases with skin changes such as ulceration, necrosis, or recurrent abscesses. In recent years, needle aspiration has emerged as the preferred treatment for uncomplicated cases. Clinical examination and radiological assessments using ultrasound or CT are crucial for establishing the diagnosis. Notably, the breast surgery community increasingly adopts needle aspiration as a minimally invasive technique for cases where the abscess size is less than 5cm on ultrasound, and symptoms have persisted for up to 5 days. Needle aspiration offers advantages such as avoiding hospital stays,eliminating the need for general anesthesia, and allowing continued breast feeding. It also reduces the risk of complications like milk fistulae. Factors such as multiple dressings for wound care, pain, dissatisfaction with cosmetic results, and delayed healing with I\&D contribute to the growing acceptance of aspiration as a suitable alternative.
Effective antimicrobial therapy is integral to the treatment of breast abscesses. Post I\&D, antibiotic coverage is mandated for preventing Surgical Site Infection (SSI). The success of aspiration, similarly, hinges on judicious antimicrobial treatment. In an era marked by antibiotic resistance, providing effective and targeted antimicrobial therapy becomes crucial.
Studies highlight the benefits of local instillation of antibiotics, demonstrating promising results in preventing SSIs and managing wounds and abscesses. Local instillation not only provides bypasses systemic administration but also reduces the need for postoperative systemic antibiotics. The concentration of antibiotics at the local site is higher when instilled locally, as evidenced by in vitro studies showing a 100% kill rate after only 60 seconds of exposure to the antibiotic irrigating solution. With advancement and diversity in the field of surgery, it is adapting to minimally invasive procedures with efficient out comes and conserving cosmetics. Aspiration for breast abscesses is replacing the conventional I\&D to provide better care, fewer complications and better cosmetic results. In stemming the rise of resistance patterns antimicrobial stewardship has become surgical obligation. Some studies show that aspiration of the breast abscess with systemic antibiotics has a success rate of up to 94%, around 50%- 60% of the cases are recovered after single aspiration while some 20%-30% required a second time and rest needed multiple aspirations. The use of local instillation of antibiotics adjunct to aspiration in management of breast abscess may help limit the number of aspirations and recurrence, providing better cure and healing time for the patients. Abscess wall and edema makes it take longer to achieve MIC (minimal inhibitory concentration) than the local instillation. It can also help to limit the use of systemic antibiotics, and promote continued breast feeding. Combined they can not only cut down the morbidity but also prove to be better in treating the breast abscess and a key step against the emerging antibiotic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle aspiration with systemic antibiotics | No intervention | – |
| Needle aspiration with local instillation of antibiotics | Active comparator | Other: Local instillation of antibiotics |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female gender Age range 14-60 years Lactating or non-lactating Clinical signs : erythema, tenderness, fever, fluctuation
Key exclusion criteria (2 listed)
- Patients refusal Male gender Acute mastitis Malignant lesion (inflammatory carcinoma) Antibioma Draining abscess/Sinus Skin ulcers / gangrene Diagnosed case of Tuberclosis H.I.V
- -
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 |
|---|---|---|
| Local instillation of antibioticsSystemic antibiotics are usually used with needle aspiration of breast abscess. However local instillation of antibiotics will be an in intervention in this study. | Other | Needle aspiration with local instillation of antibiotics |
Primary outcome
Efficacy
Time frame: From enrollment to the end of treatment at 9 days
The number of times the procedure is repeated till the resolution of symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 23303884Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
- Background: PubMed 28807202Barron AU, Luk S, Phelan HA, Williams BH. Do acute-care surgeons follow best practices for breast abscess management? A single-institution analysis of 325 consecutive cases. J Surg Res. 2017 Aug;216:169-171. doi: 10.1016/j.jss.2017.05.013. Epub 2017 May 10.
- Background: PubMed 25327913Afridi SP, Alam SN, Ainuddin S. Aspiration of breast abscess through wide bore 14-gauge intravenous cannula. J Coll Physicians Surg Pak. 2014 Oct;24(10):719-21. doi: 10.2014/JCPSP.719721.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local instillation of antibiotics in people with Breast Abscess, run by Gujranwala medical college District Headquarters Hospital, Gujranwala at 1 site in Pakistan.
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 1 inclusion and 2 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 19 Sep 2024. 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 Pakistan. 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?
Contact Arslan Anwar, M.B.B.S (+923004644375, arsalbhatti@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: From enrollment to the end of treatment at 9 days). 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 NCT06594276, which also lists 3 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 19 Sep 2024.