A Phase 4 interventional study of Silverlon and Standard Dressing in Obesity and Complications; Caesarean Section, Wound, sponsored by University of Michigan. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-04.
Sponsored by University of Michigan · Phase 4, Interventional, and Prevention
Obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients. This is a randomized controlled trial designed to determine whether the risk for wound-related complications can be reduced by covering the incision with a silver-impregnated dressing in the postoperative period.
This study's purpose was to evaluate the effect of a FDA approved silver-impregnated dressing on cesarean wound complications in obese women. It was initiated and 37 women were randomized, but because of logistical barriers, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. While a small number of photographs were taken as intended, they were lost due to a technological failure prior to any analysis. Therefore no outcome data could be analyzed. Nonetheless, as patients of the University of Michigan Health System, all research subjects received health care treatment appropriate to their medical condition and circumstances.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 37 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Device: Standard Dressing
Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Device: Silverlon
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.
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.
Number of Patients Who Experience One or More Wound Complications
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.
Time frame: 6 weeks
Febrile Morbidity
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.
Time frame: 2 days, 6 weeks
Patient Report of Pain Severity and Control
Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
Time frame: 6 weeks
| Milestone | Standard Dressing | Silverlon |
|---|---|---|
| Started | 18 | 19 |
| Hospital stay (2-5 days) | 18 | 19 |
| Completed | 0 | 0 |
| Not completed | 18 | 19 |
| Withdrew: See detailed description | 18 | 19 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Dressing | — | 0/18 (0%) | 0/18 (0%) |
| Silverlon | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Standard Dressing | Silverlon | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 19 | 37 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Standard Dressing | Silverlon | Total |
|---|---|---|---|
| Female | 18 | 19 | 37 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard Dressing | Silverlon | Total |
|---|---|---|---|
| United States | 18 | 19 | 37 |
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University of Michigan