Prospective Study on Cesarean Wound Outcomes

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01927211
Study type	Interventional
Source	Argentum Medical LLC
Contact	Melissa Cardenas, BS
Phone	813-259-8680
Email	obgynclinicalresearch@health.usf.edu
Status	Recruiting
Phase	N/A
Start date	July 2013

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.