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Clinical Trials/NCT04621994
NCT04621994UnknownNot Applicable

Cesarean Wound Closure: Dermabond Versus Steri Strips

University of Tennessee0 sites133 target enrollmentStarted: November 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
133
Primary Endpoint
Patient and Observer Scar Assessment Scale Surveys (POSAS)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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
  • •Unwilling to consent to the study

Outcomes

Primary Outcomes

Patient and Observer Scar Assessment Scale Surveys (POSAS)

Time Frame: at 1 weeks postpartum

Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.

Patient and Observer Scar Assessment Scale Surveys

Time Frame: at 6 weeks postpartum

Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin.

Secondary Outcomes

  • Number of patients with wound separation or dehiscence(through 6 weeks postpartum)
  • Number of patients with wound infection(through 6 weeks postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Grese Willingham

Assistant Professor

University of Tennessee

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