Cesarean Wound Closure: Dermabond Versus Steri Strips | NCT04621994

Studies
Cesarean Wound Closure: Dermabond Versus Steri Strips

NCT04621994

Sponsor

University of Tennessee

Status

Unknown status

Last Update Posted

Nov 9, 2020Actual

Enrollment

133Estimated

Phase

Not Applicable

Conditions

Scar

Interventions

Dermabond
Steri Strips

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2020Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Jul 2022Estimated

First Submitted Date

Oct 30, 2020

First Submission Date that Met QC Criteria

Nov 6, 2020

First Posted Date

Nov 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2020

Last Update Posted Date

Nov 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laura Grese Willingham, Assistant Professor, University of TennesseePrincipal Investigator

Lead Sponsor

University of TennesseeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

133Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Steri Strips Arm	Active Comparator		Other: Steri Strips
Dermabond Arm	Experimental		Other: Dermabond

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dermabond	Other	Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips	Dermabond Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C100832	octyl 2-cyanoacrylate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided