Parallel placement for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+3 MoreSteri-strip - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether in-line or perpendicular placement of Steri-Strips on breast surgery incisions affects healing. Patients' age, comorbid conditions, type of breast surgery, and treatment with pre-operative or post-operative chemotherapy or radiation therapy will be reviewed to ensure similar study groups. Steri-Strips will be allowed to fall off naturally and pictures will be taken of the incisional area at 30-day and 90-day follow-ups. A blinded, independent surgeon will grade each incision according to the modified Hollander Cosmesis Scale. Statistical analysis will be performed to determine significance of the

Eligible Conditions
  • Breast Cancer
  • Scarring
  • Breast Disease
  • Surgical Wound

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 90 days

30 days
Cosmesis score 30 days
90 days
Cosmesis score 90 days
Surgical site infection
Wound dehiscence

Trial Safety

Trial Design

2 Treatment Groups

Parallel placement
1 of 2
Perpendicular placement
1 of 2

Active Control

126 Total Participants · 2 Treatment Groups

Primary Treatment: Parallel placement · No Placebo Group · N/A

Parallel placement
Device
ActiveComparator Group · 1 Intervention: Steri-strip · Intervention Types: Device
Perpendicular placement
Device
ActiveComparator Group · 1 Intervention: Steri-strip · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days

Who is running the clinical trial?

Albert Einstein Healthcare NetworkLead Sponsor
60 Previous Clinical Trials
1,204,394 Total Patients Enrolled
Candace L Ward, MD, MPHPrincipal InvestigatorAlbert Einstein Medical Center Phialdelphia

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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References