Prospective Study on Cesarean Wound Outcomes

University of South Florida

Status: Completed

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

Treatments: Device: Telfa pad dressing; Device: Silver-impregnated dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01697748

USF IRB 00008650

Details and patient eligibility

About

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.

Full 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

Enrollment: 660 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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660 participants in 2 patient groups, including a placebo group

Telfa pad dressing

Placebo Comparator group

Description:

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.

Treatment:

Device: Telfa pad dressing

Silver-impregnated dressing

Active Comparator group

Description:

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.

Treatment:

Device: Silver-impregnated dressing