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Procedure

Surgical Tools for Breast Surgery Scarring (SCPPB Trial)

N/A

Waitlist Available

Led By Carol K Dingee, MD, FRCSC

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients having a total mastectomy with or without axilla surgical staging

Must not have

Patients having immediate breast reconstruction

Patients with a diagnosis of inflammatory breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-operatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the appearance of scars after mastectomy surgery using different tools. The researchers want to see if there is any difference in how the scars look when using a scalpel, electroca

Who is the study for?

This trial is for patients undergoing a total mastectomy, with or without axillary surgical staging. It excludes those planning immediate breast reconstruction, diagnosed with inflammatory breast cancer, history of keloid scars or connective tissue disorders affecting the skin, prior incisions at the mastectomy site, known suture allergies, or current infections.

What is being tested?

The study compares cosmetic outcomes from using a scalpel, standard electrocautery, and PEAK PlasmaBlade for initial skin incisions in total mastectomies without immediate reconstruction. The goal is to determine if there's a difference in scar appearance and inform future equipment choices.

What are the potential side effects?

Potential side effects may include differences in scarring quality between methods used (scalpel vs. electrocautery vs. PlasmaBlade), wound infection risks associated with each tool type and postoperative pain variations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had or will have a complete breast removal surgery, with or without lymph node assessment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having immediate breast reconstruction.

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I have been diagnosed with inflammatory breast cancer.

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I have had surgery before at the site where my mastectomy is planned.

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I currently have an infection.

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I have a history of scleroderma or rheumatoid arthritis affecting my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Scar cosmesis (SCAR scale)

Scar cosmesis (SCAR-Q)

Scar cosmesis (Vancouver Scar Scale)

Secondary study objectives

Delayed healing

Development of cellulitis

Development of excessive bruising

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Standard ElectrocauteryExperimental Treatment1 Intervention

Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.

Group II: PEAK PlasmaBladeExperimental Treatment1 Intervention

The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.

Group III: Standard of CareActive Control1 Intervention

The Standard of Care arm will consist of the scalpel for the initial skin incision and further randomization to have completion of the surgery with standard electrocautery or PEAK PlasmaBlade.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PEAK PlasmaBlade

2010

N/A

~70

0 / 6Eligibility criteria met