Mino-Wrap Medical Need - CitiusPharma2018

Medical Need (Mino-Wrap)

The highest risk for TE-related infections occurs at the time of surgery and while the drain remains in place allowing portals for microbial colonization (about two weeks post-operatively).

Rate of Infection Post-Mastectomy

  • The rate of infection post-mastectomy with the use of a tissue expander (TE) is 2.4 to 24%. Estimated mean is 12-14%*.
  • Once an implant becomes infected, the patient requires increased hospitalization and approximately 2 weeks of IV and/or oral antimicrobials. The TE is removed, leading to a possible delay of lifesaving chemo or radiation therapy, along with a more complex reconstruction in the future.

A mastectomy is an emotional, life-changing ordeal. An infection and subsequent delay in reconstructive surgery would delay the patient’s resuming pre-surgical activities.

The preventive measures used to decrease the rate of TE infections are: (a) systemic perioperative antimicrobial agents, (b) perioperative immersion of the implant or irrigation of the surgical pocket with an antimicrobial solution prior to insertion of the device, and (c) immediate postoperative oral antimicrobials. Except for (a), all of the other preventive modalities are of debatable use.

Armstrong RW. Ann Plast Surg 1989;23:284-8
Francis SH. Plast Reconstr Surg 2009;124:1790-6
Rosenblatt et al. 2015. Novel in situ liquefying antimicrobial wrap for preventing tissue expander infections following breast reconstructive surgeries. J Biomed Mater Res Part B 2015:00B.

*Please note that the 12-14% estimate for mean infection rates is an estimate from clinicians and is not a published data point.