Revista de investigacion clinica; organo del Hospital de Enfermedades de la Nutricion · 2015
Randomized Phase II Study of Talc Versus Iodopovidone for the Prevention of Seroma Formation Following Modified Radical Mastectomy.
Клиническое исследование II фазыСравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Garza-Gangemi Adrián M, Barquet-Muñoz Salim A, Villarreal-Colín Silvia P, Medina-Franco Heriberto, Cortés-González Rubén, Vilar-Compte Diana, Cantú-de-León David
Аннотация
BACKGROUND: The most common complication following modified radical mastectomy is seroma formation. Numerous approaches have been attempted to prevent this complication, ranging from the use of chemical substances to mechanical means, and none of these have proven to be consistently reliable.
AIM: The aim of this study was to evaluate the safety and efficacy of talc in preventing postoperative seromas compared with iodine and standard care.
METHODS: Patients with breast cancer undergoing modified radical mastectomy were randomly assigned to one of three study groups: control, subcutaneous talc, or iodine application. The primary endpoint was frequency of seroma formation. Secondary outcomes included wound complications (surgical site infection, flap necrosis, and wound dehiscence), analgesic use, postoperative pain, total drain outputs, and drainage duration.
RESULTS: Of the 86 patients randomized in the study, 80 were analyzed. After interim analysis, the iodine intervention was discontinued because of increased adverse outcomes (drainage duration and total amount of fluid drained). Talc failed to demonstrate that its application in subcutaneous breast tissue prevents seroma formation (19.4% for talc group vs. 23.3% for control group; p = 0.70). However, patients who developed seroma in the talc group had fewer aspirations per patient seroma and less volume drained when compared with the control group (88.2 ± 73 vs. 158.3 ± 90.5; p = 0.17).
CONCLUSIONS: Subcutaneous talc application was safe in the short term, but there was not sufficient evidence to support its use for seroma prevention following modified radical mastectomy in patients with breast cancer.
AIM: The aim of this study was to evaluate the safety and efficacy of talc in preventing postoperative seromas compared with iodine and standard care.
METHODS: Patients with breast cancer undergoing modified radical mastectomy were randomly assigned to one of three study groups: control, subcutaneous talc, or iodine application. The primary endpoint was frequency of seroma formation. Secondary outcomes included wound complications (surgical site infection, flap necrosis, and wound dehiscence), analgesic use, postoperative pain, total drain outputs, and drainage duration.
RESULTS: Of the 86 patients randomized in the study, 80 were analyzed. After interim analysis, the iodine intervention was discontinued because of increased adverse outcomes (drainage duration and total amount of fluid drained). Talc failed to demonstrate that its application in subcutaneous breast tissue prevents seroma formation (19.4% for talc group vs. 23.3% for control group; p = 0.70). However, patients who developed seroma in the talc group had fewer aspirations per patient seroma and less volume drained when compared with the control group (88.2 ± 73 vs. 158.3 ± 90.5; p = 0.17).
CONCLUSIONS: Subcutaneous talc application was safe in the short term, but there was not sufficient evidence to support its use for seroma prevention following modified radical mastectomy in patients with breast cancer.