Prospective Study on Cesarean Wound Outcomes

  • STATUS
    Recruiting
  • participants needed
    660
  • sponsor
    Argentum Medical LLC
Updated on 7 November 2020

Summary

The study will investigate whether the placement of silver plated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver plated dressings are used compared to Telfa pads. The study will examine post-operative pain by review of anesthesia and analgesic use during hospitalization and scar-related pain scores at the post-operative visits. The study will compare the percentage of patients who develop a surgical site infection after application of silver plated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance of the cesarean section scar at the patient's one week and 6 wekk post-operative visits.

Description

This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver plated dressing. The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A panel of plastic surgeons will conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks. Finally, this study will examine post-operative pain by review of anesthesia and analgesic use during hospitalization and scar-related pain scores at the post-operative visits.

Details
Condition Postoperative pain
Treatment Silver Plated dressing, Telfa pad dressing
Clinical Study IdentifierNCT01927211
SponsorArgentum Medical LLC
Last Modified on7 November 2020

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