Completed

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

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What is being tested

Telfa pad dressing

+ Silver-impregnated dressing

Device
Who is being recruted

Infections+7

+ Neurologic Manifestations

+ Pain

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2013
See protocol details

Summary

Principal SponsorUniversity of South Florida
Last updated: November 14, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2013

Actual date on which the first participant was enrolled.

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

Principal SponsorUniversity of South Florida
Last updated: November 14, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

660 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsNeurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain, PostoperativeSurgical Wound InfectionWound Infection

Criteria

8 inclusion criteria required to participate
Able and willing to provide written informed consent

Age 18 or older

Elective and emergent cesarean deliveries

Low transverse uterine incisions

Show More Criteria

4 exclusion criteria prevent from participating
Patients that did not receive routine prophylactic dose of antibiotics in the operating room

Patients with known or discovered allergy to silver or nylon

Skin incisions other than Pfannenstiel

Uterine incisions other than low transverse

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

USF Health South Tampa Center for Advanced Healthcare

Tampa, United StatesOpen USF Health South Tampa Center for Advanced Healthcare in Google Maps

Women's Center Operating Rooms at the Tampa General Hospital

Tampa, United States

USF Health Morsani Center for Advanced Healthcare

Tampa, United States
Completed3 Study Centers