| Source of record | UK Trials |
| ISRCTN | ISRCTN48887945 |
| Date ISRCTN assigned | 29/09/2006 |
| Local reference number(s) | N0265160831 |
| Public title | The role of Quixil Human Surgical Sealant in Mastectomy and Wide Local Excision with Axillary Clearance |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Breast |
| Study hypothesis | Does the use of Quixil surgical sealant reduce the post-operative blood and lymph loss, thereby reducing the time to drain removal, shortening the post-operative hospital stay? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics information provided as of 29 September 2006 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 40 patient volunteers with proven breast cancer already hooked to undergo surgery. Inclusion Criteria:
1. Patients with breast cancer undergoing either mastectomy or WLE and axillary clearance.
2. Patients able and willing to sign the Patient Informed Consent Form and agree to the study requirements.
3. Patients with a normal coagulation profile. |
| Participants - exclusion criteria | 1. Patients with signs and/or symptoms of systemic and/or local infection
2. Patients having a re-operation
3. Patients with suspected inflammatory breast cancer
4. Patients requiring concomitant surgery
5. Patients taking any form of anticoagulants |
| Patient information material |
|
| Anticipated start date | 19/09/2003 |
| Anticipated end date | 19/09/2008 |
| Status of trial | Ongoing |
| Target number of participants | 40 |
| Interventions | Forty patients, who have given informed consent will be invited to participate in the study. Patients undergoing either mastectomy or Wide Local Excision with axillary clearance / level 1&2 sampling, will be randomised to either receive an application of Quixil surgical sealant at wound closure or standard wound closure. Quixil will he spray applied to all wound surfaces prior to closure and drain insertion, in the group randomised to receive this arm of treatment. Two low vacuum suction drains will be placed, one in the axilla and the other in the chest wound. Vacuum will be applied after wound closure or 5 minutes, which ever is longer.
Time to drain removal and discharge from hospital, and drain output volumes will be the primary end points. Patient's demographic data and operative data will be collected to ensure standardisation of the two randomised groups. Any operative and postoperative complications will be recorded including wound seroma formation. Patients will be followed up in the out patients department to examine the wound at fourteen days. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | University Hospital Birmingham NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr DW England |
| Contact details | GI Surgery
Queen Elizabeth Hospital
Birmingham
United Kingdom
B15 2TH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN48887945 |
| Date last extracted from ISRCTN register | 17/04/2008 |
