MedTrace Logo

Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

NCT02263651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2018-10-22

No results posted yet for this study

Summary

The objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.

Conditions

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.

Sponsors & Collaborators

  • University Hospital, Tours

    lead OTHER

Principal Investigators

  • Lobna OULDAMER, MD · University Hospital, Tours

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT02263651 on ClinicalTrials.gov