N/A
Completed N=657
Prospective Study on Cesarean Wound Outcomes
Surgical Site Infection · Cosmetic Appearance of Cesarean Scar · Post Operative Pain
Source: ClinicalTrials.gov NCT01697748 ↗
Enrolled (actual)
657
Serious AEs
0.5%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Patients Who Develop a Surgical Site Infection — 14; 15 Participants — p=<0.05
Summary
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 and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Develop a Surgical Site Infection |
14; 15 | <0.05 sig |
| SECONDARY Cosmetic Outcome of the Cesarean Section Incision |
11.4; 11.6 | <.05 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01697748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.