Quilting Sutures After Mastectomy

NARecruitingINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

September 23, 2024

Primary Completion Date

April 30, 2027

Study Completion Date

October 31, 2027

Conditions
Breast Cancer
Interventions
PROCEDURE

Mastectomy with Quilting sutures without drain placement

The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After the mastectomy, the skin flaps are sutured onto the pectoral muscle using polyfilament absorbable sutures (e.g. Stratafix PDS® 1 CT needle) placed at 4- to 5-cm intervals in two or three rows depending on the extent of the skin flaps. Care is taken to prevent dimpling of the skin. The axillary region is also approximated. Care is taken to prevent damage to nerves and blood vessels. No suction drains are placed. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference.

PROCEDURE

Mastectomy with Conventional sutures with drain placement

The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After mastectomy no flap fixation is performed. The skin is closed in a conventional manner using an absorbable skin suture. One or two suction drains are placed before skin closure. The drains are placed in the mastectomy gutter lateral to the pectoral muscle and/or in the prepectoral area. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference. Drain output is recorded daily. Drain removal policy varies among participating centres. In some centres drain removal is based on volume of drained fluids while in other centres it depends on the postoperative time

Trial Locations (1)

3000

RECRUITING

Surgical Oncology, UZ Leuven, Leuven

All Listed Sponsors
collaborator

Belgium Health Care Knowledge Centre

OTHER_GOV

lead

Universitaire Ziekenhuizen KU Leuven

OTHER