Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06070324 |
| Other study ID # |
123476 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2023 |
| Est. completion date |
November 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Lawson Health Research Institute |
| Contact |
Tanya Delyzer, MD |
| Phone |
519-685-8108 |
| Email |
Tanya.delyzer[@]lhsc.on.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This will be a single-blinded study where participants are blinded to the suture type but the
surgeon will draw a random, unmarked envelope containing the designated suture type at the
start of the surgery. The patient population will be all patients undergoing breast surgery
at the London Health Sciences Center (LHSC) - ie. University Hospital, Victoria Hospital and
the Nazem Kadri Surgical Center, and St. Joseph's Hospital. Three (3) main procedure groups
will be transgender gender-affirming top surgery, cisgender female breast reduction or
augmentation (including healthy and cancer patients; subgroup analysis will be performed),
and cisgender male gynecomastia surgery. The goal is n=180 patients, n=60 per type of suture
with n=20 per type of procedure (totaling n=60 per type of procedure).
NAC width for each breast will be measured intraoperatively, at 2 weeks postop, 6 weeks
postop, 3 months postop, and 6 months postop. These measurements will be deidentified and
logged into a secure data entry form. Information on whether a secondary outcome occurred
(ie. infection, dehiscence, revision and nipple necrosis) will be logged in this form as
well.
Because the sutures will be kept non-visible under dressings until the clinical followup
appointment 2 weeks postop, the patient will remain blinded as to the type of suture used on
their NAC(s). At this point, absorbable sutures will have been largely dissolved and
non-absorbable sutures will be removed.
Description:
This will be a single-blinded study where the participants will be blinded to the type of
suture. The patient population will be all patients undergoing breast surgery at the London
Health Sciences Center (LHSC) - ie. University Hospital, Victoria Hospital and the Nazem
Kadri Surgical Center - and St. Joseph's Hospital falling into one of 3 categories:
transmasculine gender affirming top surgery, cisgender female elective or oncologic breast
surgery (mastopexy, breast reduction, breast augmentation, or nipple-sparing mastectomy), and
cisgender male gynecomastia correction.
Three sutures will be used: 4-0 Prolene, 4-0 Monocryl and 4-0 Stratafix. We will aim for
n=180 participants, n=60 per type of suture, and n=60 per surgical category. This way, each
suture type can be equally distributed among each surgical category. This means n=20 of each
suture type will be used in n=20 of each surgery type. For example, n=20 top surgery patients
will receive Prolene sutures, n=20 receive Monocryl, and n=20 receive Stratafix. All patients
will be consented in the preop area on the day of their surgery by a member of the research
team.
The primary outcomes will be NAC diameter or "width" intraoperatively immediately after
closing compared to NAC width 2 weeks, 6 weeks, 3 months, and 6 months postoperatively. The
horizontal and vertical widths will be measured at each time. Measurements are done with a
ruler and recorded in centimeters. Prolene sutures will be removed at the 6-week postop visit
as per current clinical practice. Absorbable will not be removed because they are absorbable.
Statistical regression will be used to determine whether a certain type(s) of suture is
optimal for minimizing NAC widening after surgery. Subgroup analyses will also be conducted
to determine any confounding factors from heterogeneity in patient factors within each group.
Secondary outcomes will be rates of infection, tip loss, nipple necrosis and dehiscence, and
whether certain types of sutures increase these adverse outcomes.
