NCT04621994

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

October 30, 2020

Last Update Submit

November 6, 2020

Conditions

Scar

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Number of patients with wound infection

    through 6 weeks postpartum

  • Number of patients with wound separation or dehiscence

    through 6 weeks postpartum

Study Arms (2)

Steri Strips Arm

ACTIVE COMPARATOR
Other: Steri Strips

Dermabond Arm

EXPERIMENTAL
Other: Dermabond

Interventions

DermabondOTHER

Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips

Dermabond Arm
Steri StripsOTHER

Steri Strips will be applied after subcuticular skin closure as routinely done at our institution

Steri Strips Arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Emergency or urgent cesarean section
  • Vertical skin incision
  • Intrapartum intraamniotic infection
  • Diabetes
  • Unwilling to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cicatrix

Interventions

octyl 2-cyanoacrylate

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 9, 2020

Study Start

November 1, 2020

Primary Completion

April 1, 2021

Study Completion

July 1, 2022

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share