Prospective Study on Cesarean Wound Outcomes

Study Overview
=================
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

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

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

Intervention / Treatment
-----------------
* Device: Silver-impregnated dressing
* Device: Telfa pad dressing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Telfa pad dressing<br>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<br>* 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.<br>* Other names: Telfa pad;|
| Active Comparator: Silver-impregnated dressing<br>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<br>* 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.<br>* Other names: Silverlon;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Develop a Surgical Site Infection | 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. | from post operative day #1 through post operative day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Outcome of the Cesarean Section Incision | The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome) | Post operative day 7 | 
| Cosmetic Outcome of the Cesarean Section Incision | 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) | Six weeks post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section incisions, silver, c-section, wound infection, scar appearance, post operative pain