in Situ Breast CancerPhase 3NCT01509781
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
A Phase 3 study testing Insertion of suction drain(s) following mastectomy and Adaptive skin sutures. in people with in Situ Breast Cancer and Invasive Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
Trial summary
The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in… Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- in Situ Breast Cancer, Invasive Breast Cancer
- What is being tested?
- Insertion of suction drain(s) following mastectomy and Adaptive skin sutures.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteHungary
- Study dates
- Sep 2011to Jan 2016
- Phase
- Phase 3
- 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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy
Who cannot join
- age above 75 years and bad general state
- pregnancy
- autoimmune disease
- non-radical excision
- mastitis carcinomatosis
- lymphangitis carcinomatosis
- wound infection necessitating treatment
Trial locations and contacts
1 site in 1 country.
Laszlo Toth, M.D., Ph.D. contact
Hungary1 site, 1 recruiting
- Recruiting
National Institute of Oncology
Budapest, Budapest, 1122
Zoltan Matrai, M.D., +3612248600 ext. 3302, matraidoc@gmail.com
About this study
Official title: Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study
The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
- Conditions
- in Situ Breast Cancer, Invasive Breast Cancer
- Being tested
- Insertion of suction drain(s) following mastectomy, Adaptive skin sutures.
- Keywords
- simple mastectomy, modified radical mastectomy, wound care, suction drain, adaptive suture
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of suction drain(s) following mastectomyProcedure or surgery
One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
Adaptive skin sutures.Procedure or surgery
Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Suction drain | Active comparator | Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy. Receives: Procedure: Insertion of suction drain(s) following mastectomy |
| Adaptive suture | Experimental | Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted. Receives: Procedure: Adaptive skin sutures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of sera withdrawn from the wound cavity
By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented.
Measured: 4 weeks
Secondary outcomes (6)
Extent of early postoperative analgesic requirements
Assessment of analgesic consumption to achieve adequate pain relief for each patient. Pain relief is carried out according to institutional protocol and includes: diclofenac sodium, diclofenac sodium + orphenadrine, nalbuphine, metamizole sodium, paracetamole, tramadole.
Measured: 4 days
Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)
Measured: 4 weeks
Rate of local wound complications.
Measured: 4 weeks
Assessment of quality of life in the early postoperative period
Using EORTC QoL BR23, weekly for 4 weeks following surgery.
Measured: 4 weeks
Mobility of the shoulder on the side of the operated side
Assessing shoulder motion on the 1st postoperative day, then weekly for 4 weeks.
Abduction 1: 0°- 45° Abduction 2: 45° - 90° Abduction 3: 90° - 135° Abduction 4: 135° - 180°
Measured: 4 weeks
Cost analysis
Suction drain, suction flask, syringes, number of patient-doctor consultations
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Situ Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Oncology, Hungary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Zoltan Matrai, National Institute of Oncology, Hungary
- Investigators
- Miklos Kasler, M.D., Ph.D., D.Sc., Prof., Principal investigator, National Institute of OncologyLaszlo Toth, M.D., Ph.D., Prof., Study chair, National Institute of OncologyFerenc Renyi Vamos, M.D., Ph.D., Study chair, National Institute of OncologyAkos Savolt, M.D., Study chair, National Institute of OncologyEmil Farkas, M.D., Study chair, National Institute of OncologyIldiko Horti, M.D., Study chair, National Institute of OncologyZoltan Matrai, M.D., Principal investigator, National Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509781
- Sponsor's protocol ID
- MRM-987/2011
- Status last verified
- Oct 2015
- First submitted
- 8 Jan 2012
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT01509781
- Acronym / sponsor ID
- MRM-987/2011
- Conditions
- in Situ Breast Cancer, Invasive Breast Cancer
- Keywords
- simple mastectomy, modified radical mastectomy, wound care, suction drain, adaptive suture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Institute of Oncology, HungaryUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2016 (estimated)
- First posted
- 13 Jan 2012 (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 prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suction drain | Active comparator | Procedure: Insertion of suction drain(s) following mastectomyPatients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy. |
| Adaptive suture | Experimental | Procedure: Adaptive skin sutures.Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy
Key exclusion criteria (7 listed)
- age above 75 years and bad general state
- pregnancy
- autoimmune disease
- non-radical excision
- mastitis carcinomatosis
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 |
|---|---|---|
| Insertion of suction drain(s) following mastectomyOne suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy. | Procedure or surgery | Suction drain |
| Adaptive skin sutures.Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery. | Procedure or surgery | Adaptive suture |
Primary outcome
Total amount of sera withdrawn from the wound cavity
Time frame: 4 weeks
By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented.
6 secondary outcomes
Extent of early postoperative analgesic requirements
Time frame: 4 days
Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)
Time frame: 4 weeks
Rate of local wound complications.
Time frame: 4 weeks
Assessment of quality of life in the early postoperative period
Time frame: 4 weeks
Mobility of the shoulder on the side of the operated side
Time frame: 4 weeks
Cost analysis
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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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.
Laszlo Toth, M.D., Ph.D. contact
Miklos Kasler, M.D., Ph.D., D.Sc., Prof. principal investigator
National Institute of Oncology
Laszlo Toth, M.D., Ph.D., Prof. study chair
National Institute of Oncology
Ferenc Renyi Vamos, M.D., Ph.D. study chair
National Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insertion of suction drain(s) following mastectomy and Adaptive skin sutures. in people with in Situ Breast Cancer and Invasive Breast Cancer, run by National Institute of Oncology, Hungary at 1 site in Hungary.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoltan Matrai, M.D. (+36 1 224 8600 ext. 3302, matraidoc@gmail.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of sera withdrawn from the wound cavity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2015.