Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cesarean Section |
Device: Surgical skin staples Device: Dermabond |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparative Study of Closure Techniques After Cesarean Section: Staples vs. Dermabond |
- Wound Complication Rate [ Time Frame: within six weeks of study intervention ] [ Designated as safety issue: Yes ]Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
- Patient Satisfaction of Cosmesis of Surgical Wound [ Time Frame: before hospital discharge after surgery ] [ Designated as safety issue: No ]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)
| Enrollment: | 136 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Women receiving Dermabond for skin closure
|
Device: Surgical skin staples
Standard method to close abdominal surgical wounds
|
|
Active Comparator: 2
Women receiving standard surgical skin staples
|
Device: Dermabond
Alternative method (superglue) to close abdominal surgical wounds
Other Name: Tissue adhesive
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations| United States, Massachusetts | |
| UMass Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01604 | |
| Principal Investigator: | Dawn S Tasillo, MD | University of Massachusetts School of Medicine |
More Information
No publications provided
| Responsible Party: | Dawn Tasillo, Assistant Professor, University of Massachusetts, Worcester |
| ClinicalTrials.gov Identifier: | NCT00524511 History of Changes |
| Other Study ID Numbers: | 12462 |
| Study First Received: | August 31, 2007 |
| Results First Received: | October 24, 2012 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Massachusetts, Worcester:
|
cesarean wound Dermabond |
superglue staples wound complications |
ClinicalTrials.gov processed this record on May 19, 2013