Prospective Study on Cesarean Wound Outcomes

Not Applicable

Completed

Conditions: Cosmetic Appearance of Cesarean Scar
Surgical Site Infection
Post Operative Pain

Interventions: Device: Telfa pad dressing
Device: Silver-impregnated dressing

Brief 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.

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.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Telfa pad dressing	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.
Silver-impregnated dressing	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Develop a Surgical Site Infection	from post operative day #1 through post operative day 30	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.

Secondary Outcome Measures

Name	Time	Method
Cosmetic Outcome of the Cesarean Section Incision	Six weeks post-operative	The following instruments will be used to determine the cosmetic outcome • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)

Locations (3): Women's Center Operating Rooms at the Tampa General Hospital
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Tampa, Florida, United States
USF Health South Tampa Center for Advanced Healthcare
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Tampa, Florida, United States
USF Health Morsani Center for Advanced Healthcare
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Tampa, Florida, United States