Comparison of Efficacy in Treating Breast Abscess, With Systemic Antibiotics Against Local Instillation of Antibiotics Along With Ultrasound Guided Aspiration.

NCT06594276 | Recruiting

• 1 other identifier: 341/GMC -23
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Abscess

Keywords

treatment of breast abscess

Outcome Measures

Primary Outcomes (1)

• Efficacy

  The number of times the procedure is repeated till the resolution of symptoms

  From enrollment to the end of treatment at 9 days

Study Arms (2)

Needle aspiration with systemic antibiotics

NO INTERVENTION

Needle aspiration with local instillation of antibiotics

ACTIVE COMPARATOR

Other: Local instillation of antibiotics

Interventions

Local instillation of antibiotics OTHER

Systemic antibiotics are usually used with needle aspiration of breast abscess. However local instillation of antibiotics will be an in intervention in this study.

Needle aspiration with local instillation of antibiotics

Eligibility Criteria

• Age: 14 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Female gender Age range 14-60 years Lactating or non-lactating Clinical signs : erythema, tenderness, fever, fluctuation

You may not qualify if:

• Patients refusal Male gender Acute mastitis Malignant lesion (inflammatory carcinoma) Antibioma Draining abscess/Sinus Skin ulcers / gangrene Diagnosed case of Tuberclosis H.I.V

Sponsors & Collaborators

• Gujranwala medical college District Headquarters Hospital, Gujranwala: lead

Study Sites (1)

Gujranwala Medical College

Gujranwala, Punjab Province, 52250, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 23303884 BACKGROUND

• Barron 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.

  PMID: 28807202 BACKGROUND

• Afridi 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.

  PMID: 25327913 BACKGROUND

Central Study Contacts

Arslan Anwar, M.B.B.S

CONTACT

+923004644375; arsalbhatti@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Graduate Resident, Master of Surgery, General Surgery.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

PA (1)