Cesarean Wound Closure: Dermabond Versus Steri Strips

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

Study Overview

• Status: Unknown
• Conditions: Scar
• Intervention / Treatment: Other: Steri Strips; Other: Dermabond

• Study Type: Interventional
• Enrollment (Anticipated): 133
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Steri Strips Arm	Other: Steri Strips; Steri Strips will be applied after subcuticular skin closure as routinely done at our institution
EXPERIMENTAL: Dermabond Arm	Other: Dermabond; Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
Number of patients with wound infection	through 6 weeks postpartum
Number of patients with wound separation or dehiscence	through 6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Tennessee Health Science Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (ACTUAL): November 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20-07302-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No