Staples Versus Dermabond for Closure of the Skin After Cesarean Section

Cesarean Section Wound Clinical Trial

Official title:

Staples Versus Dermabond for Closure of the Skin After Cesarean Section

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01261715
• Other study ID #: 155-2010
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: December 6, 2010
• Last updated: December 15, 2010
• Start date: January 2011

Study information

• Verified date: October 2010
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial Summary

Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures.

Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Woman over 18 year Woman having elective caesarean section

Exclusion Criteria:

Age under 18 Woman having an emergency caesarean section

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section Wound

Intervention

Procedure:
• Dermabond- liquid skin adhesive
Dermabond- liquid skin adhesive

Locations

Country	Name	City	State
Israel	Meir medical center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic objective evaluation of the scar		6 weeks postoperatively	No
Secondary	The difference in pain between the two type of closure		1 and 4 days postoperatively	No
Secondary	The difference in patient satisfaction with the scar result		6 weeks postoperatively	No