Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Comparison of ‘quilting sutures’ with ‘conventional’ sutures and drain placement’ after mastectomy: a multicentre, pragmatic randomised controlled trial – BE-Quilt-trial |
| Participants (P) | Patients scheduled for unilateral mastectomy without immediate breast reconstruction |
| Intervention (I) | Closing the mastectomy wound with quilting sutures without drain placement |
| Control (C) | Closing the mastectomy wound with conventional sutures and drain placement |
| Outcome (O) | • Pain in the mastectomy area scored by VAS at 6 months postoperative. • Upper limb function scored by QuickDASH at 6 months postoperative. • Cosmetic outcome scored by the patient on a 10-point scale at 6 months postoperative |
| Trial Design | Multicentre, pragmatic randomized controlled trial |
| Sample Size | 296 |
| Trial duration | 37 months |
| Budget | 1.21 Mio Euros |
Trial team
| Sponsor | UZ Leuven |
| Chief Investigator | Prof Dr Ann Smeets |
| External Partners | NA |
| Number of participating sites | 14 |
