Clinical Research Directory

A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses

The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous breast abscess drainage for disinfection of breast abscesses. The study includes two arms: (1) standard of care breast abscess drainage and (2) MB-PDT plus standard of care breast abscess drainage. The primary endpoint is time to resolution of clinical symptoms. Secondary endpoints include imaging evidence of abscess resolution, abscess recurrence, need for repeated intervention, and cure rate across treatment groups. Responses will be compared between the two study arms for the per protocol population to determine the efficacy of MB-PDT relative to standard of care. The investigators hypothesize that the addition of MB-PDT to standard of care will significantly reduce the time to symptom resolution, compared to standard of care alone.

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

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.