Prospective Study on Cesarean Wound Outcomes
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Surgical Site Infection Cosmetic Appearance of Cesarean Scar |
Device: Silver-impregnated dressing Device: Telfa pad dressing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
- To compare the percentage of patients who develop a surgical site infection [ Time Frame: Seven days postoperative ] [ Designated as safety issue: No ]
A surgical site infection involving the skin and subcutaneous tissue is defined as either
- The presence of a purulent discharge from the wound on inspection, or
- Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or
- The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.
- To compare the percentage of patients who develop a surgical site infection. [ Time Frame: Six weeks postoperative ] [ Designated as safety issue: No ]
A surgical site infection involving the skin and subcutaneous tissue is defined as either
- The presence of a purulent discharge from the wound on inspection, or
- Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or
- The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.
- To assess the cosmetic outcome of the cesarean section incision [ Time Frame: Seven days post-operative ] [ Designated as safety issue: No ]
The following instruments will be used to determine the cosmetic outcome:
- The International Advisory Panel on Scar Management
- The Observer Scar Assessment Scale
- Patient Scar Assessment Scale
- To assess the cosmetic outcome of the cesarean section incision [ Time Frame: Six weeks post-operative ] [ Designated as safety issue: No ]
The following instruments will be used to determine the cosmetic outcome:
- The International Advisory Panel on Scar Management
- The Observer Scar Assessment Scale
- Patient Scar Assessment Scale
| Estimated Enrollment: | 660 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Telfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
|
Device: Telfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Other Name: Telfa pad
|
|
Active Comparator: Silver-impregnated dressing
Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
|
Device: Silver-impregnated dressing
Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Other Name: Silverlon
|
Detailed 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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Caroline Young, MSN, ARNP | 813-259-8680 | ObGynClinicalResearch@health.usf.edu |
| Contact: Alyssa Cobb, BA, BS | 813-259-8680 | ObGynClinicalResearch@health.usf.edu |
| United States, Florida | |
| USF Health South Tampa Center for Advanced Healthcare | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Women's Center Operating Rooms at the Tampa General Hospital | Recruiting |
| Tampa, Florida, United States, 33606 | |
| USF Health Morsani Center for Advanced Healthcare | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | Sheila Connery, MD | USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology |
More Information
Publications:
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01697748 History of Changes |
| Other Study ID Numbers: | USF IRB 00008650 |
| Study First Received: | September 19, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
cesarean section incisions silver c-section wound infection scar appearance |
Additional relevant MeSH terms:
|
Surgical Wound Infection Wound Infection Cicatrix Infection |
Postoperative Complications Pathologic Processes Wounds and Injuries Fibrosis |
ClinicalTrials.gov processed this record on May 16, 2013