Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond

Conditions
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Cesarean Section

Intervention / Treatment
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* Device: Surgical skin staples
* Device: Dermabond


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women undergoing scheduled and non-scheduled cesarean deliveries Exclusion Criteria: Prisoners Insulin-requiring diabetics Vertical skin incision Allergy to Dermabond
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Women receiving Dermabond for skin closure | Device: Surgical skin staples<br>* Standard method to close abdominal surgical wounds<br>|
| Active Comparator: 2<br>Women receiving standard surgical skin staples | Device: Dermabond<br>* Alternative method (superglue) to close abdominal surgical wounds<br>* Other names: Tissue adhesive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Complication Rate | Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound | within six weeks of study intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | before hospital discharge after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean, wound, Dermabond, superglue, staples, wound complications