Prospective Study on Cesarean Wound Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
| Contact: | Melissa Cardenas, BS |
| Email: | obgynclinicalresearch@health.usf.edu |
| Phone: | 813-259-8680 |
A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Plated Dressings Compared to Conventional Dressings on Cesarean Section Incisions
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.
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.
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.
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.
Inclusion Criteria:
- Age 18 or older
- Elective and emergent cesarean deliveries
- Primary and repeat cesarean section
- Transverse skin incisions (Pfannenstiel)
- Low transverse uterine incision
- Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment
prior to or after the delivery of the baby
- Single and multiple gestations
- Willing and able to provide written informed consent
Exclusion Criteria:
- Patients that did not receive routine prophylactic dose of antibiotics in the
operating room.
- Skin incisions other than Pfannenstiel
- Uterine incisions other than low transverse
- Patients with known or discovered allergy to silver or nylon
We found this trial at
4
sites
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