The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03136159|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section; Complications, Wound, Dehiscence||Device: Silver-impregnated antimicrobial dressing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Role of Adherent Occlusive Antimicrobial Absorbent Foam Dressing in Prevention of Cesarean Section Wound Complications|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Silver-impregnated antimicrobial dressing
All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative.
Device: Silver-impregnated antimicrobial dressing
All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.
Other Name: Mepilex Border AG
- Wound complication rate [ Time Frame: 6 weeks postoperative ]Rate of wound disruption and /or infection occurring by 6 weeks will be compared to a historical control rate of 10%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136159
|Contact: Jean Goodman, MDfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Jean Goodman, MD 708-216-4033 email@example.com|
|Principal Investigator:||Jean Goodman, MD||Loyola University Chicago|