Flap Adhesion Facilitates Mastectomy without Drains
Association of Breast Surgery ePoster Library. Eichler C. 05/15/17; 166213; P153
Dr. Christian Eichler
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Abstract
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Introduction
Drain-free mastectomy is associated with reduced hospital stays and improved patient comfort. Recent NHS guidance encourages a shift towards mastectomy as Day Case surgery, with use of drains being the exception rather than the rule. Closure without drains or flap fixation is associated with increased postoperative seroma and clinical visits. Flap fixation with a high-strength adhesive may facilitate drain-free mastectomy with no increase in complications.
Methods
A German multi-center study group has accumulated a body of evidence on the use of TissuGlu® Surgical Adhesive for flap fixation in mastectomy without drain placement, comprised of early case reports, case series and several retrospective and prospective comparison cohort series. Based on this experience, a prospective study design was developed and a single center PRCT (40+40) is nearing completion. An additional 84 patient multi-center UK/Germany PRCT has been initiated with expected completion by July 2017.
Results
Initial case and series reports documented feasibility of no drain mastectomy with flap adhesion. Data from retrospective chart reviews of mastectomy +/- SLNB from 3 centers were compiled, with 44 no drain patients and 111 SWC patients with drains. Demographic variables were comparable between groups. Mean number of clinical interventions for fluid management (where a drain placement counts as 1 intervention) was 1.54 in the SWC group and 0.5 in the TissuGlu group. Rates of other minor and major complications were similar in the two groups. Data from the single center PRCT will be available in March, 2017.
Conclusions
We believe that this growing body of evidence constitutes the largest data set to date on this subject and that it will be used to support a trend towards mastectomy as day-case surgery in many countries where this is not yet the standard.
Drain-free mastectomy is associated with reduced hospital stays and improved patient comfort. Recent NHS guidance encourages a shift towards mastectomy as Day Case surgery, with use of drains being the exception rather than the rule. Closure without drains or flap fixation is associated with increased postoperative seroma and clinical visits. Flap fixation with a high-strength adhesive may facilitate drain-free mastectomy with no increase in complications.
Methods
A German multi-center study group has accumulated a body of evidence on the use of TissuGlu® Surgical Adhesive for flap fixation in mastectomy without drain placement, comprised of early case reports, case series and several retrospective and prospective comparison cohort series. Based on this experience, a prospective study design was developed and a single center PRCT (40+40) is nearing completion. An additional 84 patient multi-center UK/Germany PRCT has been initiated with expected completion by July 2017.
Results
Initial case and series reports documented feasibility of no drain mastectomy with flap adhesion. Data from retrospective chart reviews of mastectomy +/- SLNB from 3 centers were compiled, with 44 no drain patients and 111 SWC patients with drains. Demographic variables were comparable between groups. Mean number of clinical interventions for fluid management (where a drain placement counts as 1 intervention) was 1.54 in the SWC group and 0.5 in the TissuGlu group. Rates of other minor and major complications were similar in the two groups. Data from the single center PRCT will be available in March, 2017.
Conclusions
We believe that this growing body of evidence constitutes the largest data set to date on this subject and that it will be used to support a trend towards mastectomy as day-case surgery in many countries where this is not yet the standard.
Introduction
Drain-free mastectomy is associated with reduced hospital stays and improved patient comfort. Recent NHS guidance encourages a shift towards mastectomy as Day Case surgery, with use of drains being the exception rather than the rule. Closure without drains or flap fixation is associated with increased postoperative seroma and clinical visits. Flap fixation with a high-strength adhesive may facilitate drain-free mastectomy with no increase in complications.
Methods
A German multi-center study group has accumulated a body of evidence on the use of TissuGlu® Surgical Adhesive for flap fixation in mastectomy without drain placement, comprised of early case reports, case series and several retrospective and prospective comparison cohort series. Based on this experience, a prospective study design was developed and a single center PRCT (40+40) is nearing completion. An additional 84 patient multi-center UK/Germany PRCT has been initiated with expected completion by July 2017.
Results
Initial case and series reports documented feasibility of no drain mastectomy with flap adhesion. Data from retrospective chart reviews of mastectomy +/- SLNB from 3 centers were compiled, with 44 no drain patients and 111 SWC patients with drains. Demographic variables were comparable between groups. Mean number of clinical interventions for fluid management (where a drain placement counts as 1 intervention) was 1.54 in the SWC group and 0.5 in the TissuGlu group. Rates of other minor and major complications were similar in the two groups. Data from the single center PRCT will be available in March, 2017.
Conclusions
We believe that this growing body of evidence constitutes the largest data set to date on this subject and that it will be used to support a trend towards mastectomy as day-case surgery in many countries where this is not yet the standard.
Drain-free mastectomy is associated with reduced hospital stays and improved patient comfort. Recent NHS guidance encourages a shift towards mastectomy as Day Case surgery, with use of drains being the exception rather than the rule. Closure without drains or flap fixation is associated with increased postoperative seroma and clinical visits. Flap fixation with a high-strength adhesive may facilitate drain-free mastectomy with no increase in complications.
Methods
A German multi-center study group has accumulated a body of evidence on the use of TissuGlu® Surgical Adhesive for flap fixation in mastectomy without drain placement, comprised of early case reports, case series and several retrospective and prospective comparison cohort series. Based on this experience, a prospective study design was developed and a single center PRCT (40+40) is nearing completion. An additional 84 patient multi-center UK/Germany PRCT has been initiated with expected completion by July 2017.
Results
Initial case and series reports documented feasibility of no drain mastectomy with flap adhesion. Data from retrospective chart reviews of mastectomy +/- SLNB from 3 centers were compiled, with 44 no drain patients and 111 SWC patients with drains. Demographic variables were comparable between groups. Mean number of clinical interventions for fluid management (where a drain placement counts as 1 intervention) was 1.54 in the SWC group and 0.5 in the TissuGlu group. Rates of other minor and major complications were similar in the two groups. Data from the single center PRCT will be available in March, 2017.
Conclusions
We believe that this growing body of evidence constitutes the largest data set to date on this subject and that it will be used to support a trend towards mastectomy as day-case surgery in many countries where this is not yet the standard.
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