Breast Cancer SurgeryNCT00830271
Vicryl Plus and Monocryl Plus in Breast Surgery
A study testing Vicryl plus and Monocryl plus and wound closure with Vicryl and Monocryl in people with Breast Cancer Surgery, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Surgery
- What is being tested?
- Vicryl plus and Monocryl plus and wound closure with Vicryl and Monocryl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Apr 2011
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery
Who cannot join
- patients unable to give consent or comply with follow up
- patients undergoing surgery for benign disease
- patients with inflammatory cancers or skin ulceration
- patients having neo-adjuvant chemotherapy or radiotherapy
- patients with known allergy to triclosan antiseptic
- patients with immune deficiency diseases
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff and Vale NHS Trust
Cardiff, Wales, CF14 4XN
About this study
Official title: Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery
This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.
- Conditions
- Breast Cancer Surgery
- Being tested
- Vicryl plus and Monocryl plus, wound closure with Vicryl and Monocryl
- Keywords
- surgical site infection, wound complications, suture, antiseptic, wound closure
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl plus and Monocryl plusDevice
closure of skin and subcutaneous tissues
wound closure with Vicryl and MonocrylDevice
wound closure skin and subcutaneous tissues
| Study group | Role | What they receive |
|---|---|---|
| Vicryl plus/Monocryl plus | Experimental | Vicryl plus and Monocryl plus is the active comparator arm. These are the "active" sutures, coated with triclosan antiseptic, being used in the closure of skin and subcutaneous tissues after breast cancer surgery. Receives: Device: Vicryl plus and Monocryl plus |
| vicryl/monocryl | Placebo comparator | "Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control. Receives: Device: wound closure with Vicryl and Monocryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of surgical site infection
Measured: 6-7 months
Secondary outcomes (1)
estimation time in hospital and return to work numbers of haematomas and seromas
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830271
- Sponsor's protocol ID
- C624/07
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Vicryl Plus and Monocryl Plus in Breast Surgery
- ClinicalTrials.gov ID
- NCT00830271
- Acronym / sponsor ID
- C624/07
- Conditions
- Breast Cancer Surgery
- Keywords
- surgical site infection, wound complications, suture, antiseptic, wound closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- Dec 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Jan 2009 (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.
This is a randomised pilot study comparing conventional sutures (Vicryl and Monocryl) with antiseptic coated equivalents (Vicryl plus andf Monocryl plus) in elective breast surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl plus/Monocryl plus | Experimental | Device: Vicryl plus and Monocryl plusVicryl plus and Monocryl plus is the active comparator arm. These are the "active" sutures, coated with triclosan antiseptic, being used in the closure of skin and subcutaneous tissues after breast cancer surgery. |
| vicryl/monocryl | Placebo comparator | Device: wound closure with Vicryl and Monocryl"Plain" Vicryl or Monocryl suture currently the standard which are not coated with triclosan, serve as the control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over 18 years old who attend the Cardiff and Vale NHS Trust for elective breast cancer surgery
Key exclusion criteria (6 listed)
- patients unable to give consent or comply with follow up
- patients undergoing surgery for benign disease
- patients with inflammatory cancers or skin ulceration
- patients having neo-adjuvant chemotherapy or radiotherapy
- patients with known allergy to triclosan antiseptic
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 |
|---|---|---|
| Vicryl plus and Monocryl plusclosure of skin and subcutaneous tissues | Device | Vicryl plus/Monocryl plus |
| wound closure with Vicryl and Monocrylwound closure skin and subcutaneous tissues | Device | vicryl/monocryl |
Primary outcome
reduction of surgical site infection
Time frame: 6-7 months
1 secondary outcome
estimation time in hospital and return to work numbers of haematomas and seromas
Time frame: 6-9 months
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 30 Jan 2020.
Related trials for Breast Cancer Surgery
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Inflammatory Breast Cancer, Stage IIA Breast Cancer
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Breast Cancer
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl plus and Monocryl plus and wound closure with Vicryl and Monocryl in people with Breast Cancer Surgery, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 6 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 30 Jan 2020. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
reduction of surgical site infection (time frame: 6-7 months). 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 30 Jan 2020.