Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage

NCT02263651 | Completed

• 3 other identifiers: PHRCK13 - LO / QUISERMAS2014-A00901-46140730B-12
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 6

Brief 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

Breast Cancer

Keywords

Breast cancer; Mastectomy; Seroma; Quilting suture

Outcome Measures

Primary Outcomes (1)

• Wound seroma requiring aspiration or surgical intervention

  A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles). Only grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.

  Within 21 days following mastectomy

Secondary Outcomes (11)

• Wound seroma requiring aspiration or surgical intervention

  Within 9 months following mastectomy

• Wound seroma whatever their type (requiring or not intervention)

  Within 21 days following mastectomy

• Wound seroma whatever their type (requiring or not intervention)

  Within 9 months following mastectomy

• Other wound complications

  Within 21 days following mastectomy

• Other wound complications

  Within 9 months following mastectomy

Study Arms (2)

Closure with conventional technique with drainage

ACTIVE COMPARATOR

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.

Procedure: Conventional closure with drainage

Quilting suture without drainage

EXPERIMENTAL

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.

Procedure: Quilting suture without drainage

Interventions

Quilting suture without drainage PROCEDURE

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.

Also known as: Quilting suture

Quilting suture without drainage

Conventional closure with drainage PROCEDURE

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.

Also known as: Conventional closure

Closure with conventional technique with drainage

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years and ≤ 85 years
• Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level I/II axillary node dissection
• Women that give her informed written consent
• French social security affiliation

You may not qualify if:

• Any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection.
• Women with indication of bilateral mastectomy or immediate reconstruction.
• Degenerative neuromuscular disease with thoracic muscular damage
• Planned ambulatory surgery

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (6)

Conception Hospital

Marseille, 13005, France

Location

Institut POALI-CALMETTES

Marseille, 13009, France

Location

Institut de Cancérologie de l'Ouest

Nantes, France

Location

CHU de Poitiers

Poitiers, France

Location

Alliance Clinic

Saint-Cyr-sur-Loire, France

Location

CHRU de Tours

Tours, France

Location

Related Publications (1)

• Ouldamer L, Bonastre J, Brunet-Houdard S, Body G, Giraudeau B, Caille A. Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 4;6(4):e009903. doi: 10.1136/bmjopen-2015-009903.

  PMID: 27044574 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Drainage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Lobna OULDAMER, MD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

FR (6)