Cesarean Wound Closure: Dermabond Versus Steri Strips

Scar Clinical Trial

Official title:

Cesarean Wound Closure: Dermabond Versus Steri Strips

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04621994
• Other study ID #: 20-07302-FB
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2020
• Est. completion date: July 2022

Study information

• Verified date: November 2020
• Source: University of Tennessee Health Science Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 133
• Est. completion date: July 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health

• Gestational age > 24 weeks

• Planned Pfannenstiel incision

• Willing to consent to the study

Exclusion Criteria:

• Emergency or urgent cesarean section

• Vertical skin incision

• Intrapartum intraamniotic infection

• Diabetes

• Unwilling to consent to the study

Related Conditions & MeSH terms

• Scar

Intervention

Other:
• Dermabond
Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips
• Steri Strips
Steri Strips will be applied after subcuticular skin closure as routinely done at our institution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Health Science Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Observer Scar Assessment Scale Surveys (POSAS)	Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.	at 1 weeks postpartum
Primary	Patient and Observer Scar Assessment Scale Surveys	Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.	at 6 weeks postpartum
Secondary	Number of patients with wound infection		through 6 weeks postpartum
Secondary	Number of patients with wound separation or dehiscence		through 6 weeks postpartum