NCT03052647

Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Rubino Ob-Gyn Group · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.

Conditions

• Wound

Interventions

Type	Name	Description
DEVICE	Dermaclip	Dermaclip is an adhesive latch device used for skin closure
DEVICE	Subcuticular suture	subcuticular suture will be used as the device to close the skin in this arm

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-11-30
• Completion: 2018-03-01
• First posted: 2017-02-14
• Last updated: 2017-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study