Clinical trial NCT02263651: Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
Official title: Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Mastectomy
Seroma
Quilting suture
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Eligible patients are patients 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

Randomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).

Two follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Wound seroma requiring aspiration or surgical intervention
timeFrame: Within 21 days following mastectomy
Secondary outcomes:
measure: Wound seroma requiring aspiration or surgical intervention
timeFrame: Within 9 months following mastectomy
measure: Wound seroma whatever their type (requiring or not intervention)
timeFrame: Within 21 days following mastectomy
measure: Wound seroma whatever their type (requiring or not intervention)
timeFrame: Within 9 months following mastectomy
measure: Other wound complications
timeFrame: Within 21 days following mastectomy
measure: Other wound complications
timeFrame: Within 9 months following mastectomy
measure: Surgical morbidity
timeFrame: During surgical intervention
measure: Pain
timeFrame: Before surgery, day 1, 21 days and 9 months following mastectomy
measure: Homolateral shoulder movement
timeFrame: Before surgery, 21 days and 9 months following mastectomy
measure: Cosmesis results
timeFrame: 21 days, 9 months following mastectomy
measure: Health related quality of life : EQ-5D-5L
timeFrame: Before surgery, day 1, 21 days and 9 months following mastectomy
measure: Cost-effectiveness assessment
timeFrame: During the whole follow-up period i.e. 9 months following mastectomy
Other outcomes:
Locations:
city: Marseille
country: France
facility: Conception Hospital
city: Marseille
country: France
facility: Institut POALI-CALMETTES
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest
city: Poitiers
country: France
facility: CHU de Poitiers
city: St Cyr sur Loire
country: France
facility: Alliance Clinic
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: University Hospital, Tours
name: Lobna OULDAMER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.