Obesity, Complications; Caesarean Section, Wound
Conditions
Keywords
Obesity, Cesarean Section, Wound care
Brief summary
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.
Detailed description
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.
Interventions
DEVICESilverlon
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.
DEVICEStandard 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.
Sponsors
Cura Surgical
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Undergoing cesarean section (with or without concurrent tubal ligation) * Body mass index (based on most recent weight) \>=30
Exclusion criteria
* Known allergy to silver * Less than 18 years of age * Preoperative evidence of current abdominal wall infection * Contraindication to closure of the skin at time of surgery * Plan to perform procedures in addition to cesarean section (with or without tubal ligation) * Patients with previously placed abdominal wall mesh at site of planned surgery * Inability to participate in medical decision making * Inability to follow up with the Michigan Visiting Nurses or are unable to return to the University of Michigan Medical Center for staple removal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experience One or More Wound Complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Febrile Morbidity | 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 | 6 weeks | Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Dressing Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
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. | 18 |
| Silverlon Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
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. | 19 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | See detailed description | 18 | 19 |
Baseline characteristics
| Characteristic | Standard Dressing | Silverlon | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Region of Enrollment United States | 18 participants | 19 participants | 37 participants |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 37 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
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
Population: For logistical reasons, 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. Therefore no outcome data could be analyzed.
Secondary
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
Population: For logistical reasons, 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. Therefore no outcome data could be analyzed.
Secondary
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
Population: For logistical reasons, 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. Therefore no outcome data could be analyzed.