[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473807":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":32,"studyPopulation":22,"armGroups":33,"interventions":45,"overallOfficials":51,"centralContacts":55,"locations":60,"responsibleParty":127,"collaborators":22,"id":131,"slug":22,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":22,"enrollmentInfo":140,"targetDuration":22,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":62,"whyStopped":22,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University Hospitals of Derby and Burton NHS Foundation Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":22},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Clinician acceptance","Proportion of eligible women offered the trial","2 years",{"measure":14,"description":15,"timeFrame":12},"Patient acceptance","Proportion of women offered the trial who participate in the trial",{"measure":17,"description":18,"timeFrame":12},"Recruitment rate","Number of patient recruited per year per site",{"measure":20,"description":21,"timeFrame":12},"Compliance with allocated intervention","Number of patients not complying with randomisation allocation",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":29,"whoMasked":30},"SINGLE","Single blind masking",[31],"PARTICIPANT","Immediate breast reconstruction in women undergoing removal of the whole breast for cancer or risk reduction is most commonly done using breast implants. Surgeons often use a sheet of mesh to cover the implant as standard treatment. It acts like an internal bra and supports the implant and re-creates a natural looking breast.\n\nNatural(biological) or man-made (synthetic) meshes are used routinely in the NHS. Biological ones are made from animal tissue (pig, cow) that have been made safe to use in people and are costly. Synthetic meshes are made from net-like fabric and cost less. The choice about which mesh to use depends on surgeons' personal experience and how much money the hospital has for these operations. The two meshes may have different acceptability issues for patients because of their personal values, religious beliefs, ethnic background or views on animal welfare.\n\nA large UK review of breast reconstruction with implants gathered information up to 3 months after surgery on the use and outcomes of the two meshes. This suggests that both may be equally safe in the short-term. However, this information can be improved by comparing the meshes side-by-side and looking at how safe they are long-term. This is important as some side-effects only appear later after surgery. Clinicians do not know how outcomes impact on patients' health and well-being.\n\nThe best proof would come from a randomised surgical study, where a computer allocates patients to receive either the biological or synthetic mesh. Investigators will measure how patients feel, how their health is, and record if they have any side-effects from the reconstructive surgery. This type of study would tell us how good each mesh is and if they are safe long-term.\n\nBefore starting such a study, investigators will run a smaller one that will help us understand if patients and surgeons would be comfortable taking part.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Biological Matrix","ACTIVE_COMPARATOR","Participants will undergo immediate breast reconstruction using biological matrix and implant",[39],"Procedure: One-stage immediate breast reconstruction",{"label":41,"type":42,"description":43,"interventionNames":44},"Synthetic Mesh","EXPERIMENTAL","Participants will undergo immediate breast reconstruction using synthetic mesh and implant",[39],[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":22},"PROCEDURE","One-stage immediate breast reconstruction","One-stage mesh assisted implant breast reconstruction",[35,41],[52],{"name":53,"affiliation":5,"role":54},"Amit Goyal, MS, MD, FRCS","STUDY_CHAIR",[56],{"name":53,"role":57,"phone":58,"phoneExt":22,"email":59},"CONTACT","01332786958","amit.goyal@nhs.net",[61,78,90,102,115],{"facility":5,"status":62,"city":63,"state":22,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Derby","DE22 3NE","United Kingdom","UK",{"type":68,"coordinates":69},"Point",[70,71],-1.47663,52.92277,{"lat":71,"lon":70},[74,76],{"name":75,"role":57,"phone":22,"phoneExt":22,"email":22},"Emanuele Garreffa",{"name":22,"role":57,"phone":22,"phoneExt":22,"email":77},"emanuele.garreffa@nhs.net",{"facility":79,"status":62,"city":80,"state":22,"zip":22,"country":65,"countryCode":66,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Wycombe Hospital","High Wycombe",{"type":68,"coordinates":82},[83,84],-0.74934,51.62907,{"lat":84,"lon":83},[87],{"name":88,"role":57,"phone":22,"phoneExt":22,"email":89},"Fiona Tsang-Wright","fiona.tsangwright@nhs.net",{"facility":91,"status":62,"city":92,"state":22,"zip":22,"country":65,"countryCode":66,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Castle Hill Hospital","Hull",{"type":68,"coordinates":94},[95,96],-0.33525,53.7446,{"lat":96,"lon":95},[99],{"name":100,"role":57,"phone":22,"phoneExt":22,"email":101},"Kartikae Grover","kartikaegrover@nhs.net",{"facility":103,"status":62,"city":104,"state":22,"zip":22,"country":65,"countryCode":66,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"University Hospitals of Leicester NHS Trust","Leicester",{"type":68,"coordinates":106},[107,108],-1.13169,52.6386,{"lat":108,"lon":107},[111,113],{"name":112,"role":57,"phone":22,"phoneExt":22,"email":22},"Monika Kaushik",{"name":22,"role":57,"phone":22,"phoneExt":22,"email":114},"monika.kaushik@uhl-tr.nhs.uk",{"facility":116,"status":62,"city":117,"state":22,"zip":22,"country":65,"countryCode":66,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Nottingham City Hospital","Nottingham",{"type":68,"coordinates":119},[120,121],-1.15047,52.9536,{"lat":121,"lon":120},[124],{"name":125,"role":57,"phone":22,"phoneExt":22,"email":126},"Hazem Khout","Hazem.Khout@nuh.nhs.uk",{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Dr Amit Goyal","Chief Investigator","100473807",false,"NCT05449691","Biological Matrices Versus Synthetic Meshes","BIOSYM - A Feasibility Randomised Controlled Trial Comparing Biological Matrices With Synthetic Meshes in Women Undergoing One Stage Implant Based Breast Reconstruction","BIOSYM","Inclusion Criteria:\n\nFemale age ≥ 18 Women undergoing mastectomy and immediate one-stage mesh assisted implant breast reconstruction as standard treatment\n\nExclusion Criteria:\n\nRevision reconstruction surgery Delayed reconstruction surgery","FEMALE","18 Years",{"count":141,"type":142},60,"ESTIMATED","INTERVENTIONAL",[145],"NA","In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.",[148],"Breast Cancer",[150,151,152,153,154,155],"breast reconstruction","mesh","acellular dermal matrix","synthetic mesh","breast cancer","patient reported outcome","2025-09-03",{"date":158,"type":159},"2025-09-10","ACTUAL",{"date":161,"type":159},"2023-11-02",{"date":163,"type":142},"2026-04-30",{"name":5,"class":6},5]