Prospective Study on Cesarean Wound Outcomes

October 25, 2019 updated by: University of South Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

660

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • USF Health Morsani Center For Advanced Healthcare
      • Tampa, Florida, United States, 33606
        • USF Health South Tampa Center for Advanced Healthcare
      • Tampa, Florida, United States, 33606
        • Women's Center Operating Rooms at the Tampa General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 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
Time Frame: 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.
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
Time Frame: Post operative day 7

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
Time Frame: 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)
Six weeks post-operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Pain After Cesarean Delivery
Time Frame: Immediately post operatively to hospital discharge
The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded
Immediately post operatively to hospital discharge
The Number of Participants Noting Pain at the One Week Post Cesarean Visit
Time Frame: Post operative day 7
Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.
Post operative day 7
The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit
Time Frame: 6 weeks post operative
Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.
6 weeks post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Principal Investigator: Sheila Connery, MD, USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

October 2, 2012

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USF IRB 00008650

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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