Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
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|ClinicalTrials.gov Identifier: NCT01528696|
Recruitment Status : Terminated (Insufficient Recruitment)
First Posted : February 8, 2012
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity Complications; Caesarean Section, Wound||Device: Silverlon Device: Standard Dressing||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Placebo Comparator: Standard Dressing
Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Device: Standard Dressing
Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.
- Number of Patients Who Experience One or More Wound Complications [ Time Frame: 6 weeks ]A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report.
- Febrile Morbidity [ Time Frame: 2 days, 6 weeks ]Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery.
- Patient Report of Pain Severity and Control [ Time Frame: 6 weeks ]Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
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): NCT01528696
|United States, Michigan|
|University of Michigan Von Voigtlander Womens' Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Mark Chames, MD||University of Michigan|
|Principal Investigator:||Angela Liang, MD||University of Michigan|