Breast CancerQUISERMASNCT02263651
Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage
A study testing Quilting suture without drainage and Conventional closure with drainage in people with Breast Cancer, run by University Hospital, Tours at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Quilting suture without drainage and Conventional closure with drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Conception Hospital
Marseille, 13005
Institut POALI-CALMETTES
Marseille, 13009
Institut de Cancérologie de l'Ouest
Nantes
CHU de Poitiers
Poitiers
Alliance Clinic
Saint-Cyr-sur-Loire
CHRU de Tours
Tours
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Quilting suture without drainage, Conventional closure with drainage
- Keywords
- Breast cancer, Mastectomy, Seroma, Quilting suture
- Medical subject headings
- Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quilting suture without drainageProcedure or surgery
Also called Quilting suture
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.
Conventional closure with drainageProcedure or surgery
Also called Conventional closure
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Quilting suture without drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 21 days following mastectomy
Secondary outcomes (11)
Wound seroma requiring aspiration or surgical intervention
Measured: Within 9 months following mastectomy
Wound seroma whatever their type (requiring or not intervention)
Measured: Within 21 days following mastectomy
Wound seroma whatever their type (requiring or not intervention)
Measured: Within 9 months following mastectomy
Other wound complications
Measured: Within 21 days following mastectomy
Other wound complications
Measured: Within 9 months following mastectomy
Surgical morbidity
Measured: During surgical intervention
Pain
Visual Analogue Scale
Measured: Before surgery, day 1, 21 days and 9 months following mastectomy
Homolateral shoulder movement
The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)
Measured: Before surgery, 21 days and 9 months following mastectomy
Cosmesis results
Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent
Measured: 21 days, 9 months following mastectomy
Health related quality of life : EQ-5D-5L
The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems
Measured: Before surgery, day 1, 21 days and 9 months following mastectomy
Cost-effectiveness assessment
Incremental net monetary benefice
Measured: During the whole follow-up period i.e. 9 months following mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lobna OULDAMER, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263651
- Sponsor's protocol ID
- PHRCK13 - LO / QUISERMAS
- Other IDs
- 2014-A00901-46, 140730B-12
- Acronym
- QUISERMAS
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2014
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27044574
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02263651
- Acronym / sponsor ID
- QUISERMAS / PHRCK13 - LO / QUISERMAS
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Mastectomy, Seroma, Quilting suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closure with conventional technique with drainage | Active comparator | Procedure: Conventional closure with drainageThe 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. |
| Quilting suture without drainage | Experimental | Procedure: Quilting suture without drainageIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quilting suture without drainageAlso: Quilting sutureIn 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 or surgery | Quilting suture without drainage |
| Conventional closure with drainageAlso: Conventional closureThe 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. | Procedure or surgery | Closure with conventional technique with drainage |
Primary outcome
Wound seroma requiring aspiration or surgical intervention
Time frame: Within 21 days following mastectomy
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.
11 secondary outcomes
Wound seroma requiring aspiration or surgical intervention
Time frame: Within 9 months following mastectomy
Wound seroma whatever their type (requiring or not intervention)
Time frame: Within 21 days following mastectomy
Wound seroma whatever their type (requiring or not intervention)
Time frame: Within 9 months following mastectomy
Other wound complications
Time frame: Within 21 days following mastectomy
Other wound complications
Time frame: Within 9 months following mastectomy
Surgical morbidity
Time frame: During surgical intervention
Pain
Time frame: Before surgery, day 1, 21 days and 9 months following mastectomy
Homolateral shoulder movement
Time frame: Before surgery, 21 days and 9 months following mastectomy
Cosmesis results
Time frame: 21 days, 9 months following mastectomy
Health related quality of life : EQ-5D-5L
Time frame: Before surgery, day 1, 21 days and 9 months following mastectomy
Cost-effectiveness assessment
Time frame: During the whole follow-up period i.e. 9 months following mastectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Derived from this study: PubMed 27044574Ouldamer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lobna OULDAMER, MD principal investigator
University Hospital, Tours
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quilting suture without drainage and Conventional closure with drainage in people with Breast Cancer, run by University Hospital, Tours at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound seroma requiring aspiration or surgical intervention (time frame: Within 21 days following mastectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02263651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.