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Effect of Suture Material on Postoperative Nipple Areolar Complex Widening

NCT06070324 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Breast surgery

Any surgery involving incisions made along the nipple areolar complex. These would include transgender mastectomy, cisgender female breast reduction/augmentation/reconstruction, and cisgender male gynecomastia correction.

DEVICE

Suturing of surgical incision

The closing of a surgical incision by using sutures so appose and maintain apposition of two skin edges. Suturing may or may not require knot-tying depending on the material of suture used.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-02-29
Completion
2024-11-30
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070324 on ClinicalTrials.gov