Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-12-20
Brief Title:
Cosmetic Outcome of Electrocautery Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCPPB
Brief Summary:
This study will compare the cosmetic scar result from the use of scalpel electrocautery and pulsed electron avalanche knife PEAK PlasmaBlade PPB for the initial skin incision for total mastectomy procedures without immediate breast reconstruction
It is hypothesized that there will be no significant difference in mastectomy scar cosmesis
The purpose and objectives of this study are
1 To evaluate and compare the cosmetic scar result from the use of scalpel standard electrocautery or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction
2 To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks
It is hypothesized that there will be no significant difference in mastectomy scar cosmesis
The purpose and objectives of this study are
1 To evaluate and compare the cosmetic scar result from the use of scalpel standard electrocautery or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction
2 To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks
Detailed Description:
Scalpel electrocautery and PEAK PlasmaBlade PPB have all been shown to be safe techniques for surgical incision but no study has proven the superiority for cosmesis for PPB incision when compared to conventional electrocautery or scalpel
The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy - axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel standard electrocautery or PEAK PlasmaBlade
Scar cosmesis will be evaluated postoperatively at two-to-four weeks six months and twelve months by two independent observers blinded to the equipment used and patient reported outcomes will be reported using the validated SCAR-Q questionnaire
The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy - axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel standard electrocautery or PEAK PlasmaBlade
Scar cosmesis will be evaluated postoperatively at two-to-four weeks six months and twelve months by two independent observers blinded to the equipment used and patient reported outcomes will be reported using the validated SCAR-Q questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None