Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

NACompletedINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Breast Cancer
Interventions
PROCEDURE

Quilting suture without drainage

"In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (\<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.~Efficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.~The skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area."

PROCEDURE

Conventional closure with drainage

"The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.~The skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent."

Trial Locations (6)

13005

Conception Hospital, Marseille

13009

Institut POALI-CALMETTES, Marseille

Unknown

Institut de Cancérologie de l'Ouest, Nantes

CHU de Poitiers, Poitiers

Alliance Clinic, Saint-Cyr-sur-Loire

CHRU de Tours, Tours

All Listed Sponsors
lead

University Hospital, Tours

OTHER

NCT02263651 - Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage | Biotech Hunter | Biotech Hunter