Prospective Study on Cesarean Wound Outcomes
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | September 2013 |
| End Date: | May 2018 |
A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Impregnated Dressings Compared to Conventional Dressings on Cesarean Section Incisions
This study will investigate whether the placement of silver impregnated 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 impregnated dressings are used compared to the Telfa pads.
The study will compare the percentage of patients who develop a surgical site infection after
application of silver impregnated 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 week post-operative visits.
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 impregnated dressings are used compared to the Telfa pads.
The study will compare the percentage of patients who develop a surgical site infection after
application of silver impregnated 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 week 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 impregnated dressing.
The primary objective is to compare the percentage of patients who develop a surgical site
infection between the two groups at the 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 plastic surgery investigator will also conduct
a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at
1-week and 6-weeks.
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 impregnated dressing.
The primary objective is to compare the percentage of patients who develop a surgical site
infection between the two groups at the 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 plastic surgery investigator will also conduct
a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at
1-week and 6-weeks.
Inclusion Criteria:
- Age 18 or older
- Elective and emergent cesarean deliveries
- Primary and repeat cesarean sections
- Transverse skin incisions (Pfannenstiel)
- Low transverse uterine incisions
- Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment
prior to or after the delivery of the baby
- Single and multiple gestations
- Able and willing 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
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