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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04621994
Other study ID # 20-07302-FB
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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