Cesarean Section
Conditions
Keywords
cesarean, wound, Dermabond, superglue, staples, wound complications
Brief summary
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.
Interventions
DEVICESurgical skin staples
Standard method to close abdominal surgical wounds
DEVICEDermabond
Alternative method (superglue) to close abdominal surgical wounds
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Pregnant women undergoing scheduled and non-scheduled cesarean deliveries
Exclusion criteria
* Prisoners * Insulin-requiring diabetics * Vertical skin incision * Allergy to Dermabond
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complication Rate | within six weeks of study intervention | Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction of Cosmesis of Surgical Wound | before hospital discharge after surgery | survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable) |
Countries
United States
Participant flow
Recruitment details
September 4, 2007-July 9, 2010 Recruitment occured in the medical clinics and Labor and Delivery unit of an academic medical center
Pre-assignment details
The study design dictates that patients be enrolled upon admission to Labor and Delivery. Subsequently, patients who did not deliver by cesarean delivery would be excluded
Participants by arm
| Arm | Count |
|---|---|
| Group Receiving Alternative Skin Closure Method (Dermabond) Women receiving Dermabond for skin closure | 68 |
| Group Receiving Standard Skin Closure Method (Surgical Staples Women receiving standard surgical skin staples | 68 |
| Total | 136 |
Baseline characteristics
| Characteristic | Group Receiving Alternative Skin Closure Method (Dermabond) | Group Receiving Standard Skin Closure Method (Surgical Staples | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 68 Participants | 135 Participants |
| Sex: Female, Male Female | 68 Participants | 68 Participants | 136 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 / 68 | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 | 0 / 68 |
Outcome results
Primary
Wound Complication Rate
Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
Time frame: within six weeks of study intervention
Population: No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.
Secondary
Patient Satisfaction of Cosmesis of Surgical Wound
survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)
Time frame: before hospital discharge after surgery
Population: No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.