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| Name | Class |
|---|---|
| Western University | OTHER |
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In women who undergo mastectomy for the treatment of breast cancer, autologous reconstruction using the deep inferior epigastric perforator (DIEP) flap is a common surgical procedure that aims to restore both the appearance and texture of the breast(s).Specifically, this requires the transfer of skin, fat, and perforator vessels from the abdomen to a recipient artery and vein in the chest to create a viable breast mound. Post-operatively, the abdominal donor site is routinely monitored for wound dehiscence, which has a reported incidence of up to 39% in this patient population; however, this incidence typically varies from 3.5% to 14%.
At the investigators' academic institution, patients who undergo DIEP breast reconstruction typically have ciNPT or traditional tape dressings applied to the closed abdominal donor site. These dressings are selected according to surgeon preference and typically remain in-situ until hospital discharge. As there remains clinical equipoise regarding the ability of ciNPT to reduce abdominal wound dehiscence, further research in the form of a parallel, two-arm RCT is warranted.
The investigators propose a randomized controlled superiority trial with the primary objective of comparing the incidence of wound dehiscence at 1 month in patients undergoing autologous DIEP breast reconstruction with ciNPT versus standard tape dressings for the abdominal donor site incision. The design and conduct of the proposed study will mirror the methodology of the recently completed pilot trial (NCT04985552) including randomization, interventions, and clinical outcomes.
The secondary objective of this study is to evaluate other clinical outcomes comparing ciNPT to standard tape dressings applied to the abdominal donor site incision. Secondary clinical outcomes will include: 2) the incidence of seroma formation and surgical site infection at 1 month; 2) quality of life as measured by BREAST-Q physical well-being abdomen and EQ-5D-5L pre-operatively, 1-month, 3-months, and 6-months postoperatively; 3) Scar appearance as measured by the SCAR-Q at 1-month, 3-months, and 6-months postoperatively.
As an adjunct to the main study, another secondary clinical outcome will include the overall incidence of MINS as diagnosed by postoperative abnormally elevated troponin levels (as per site-specific laboratory assay thresholds) and electrocardiograms (ECG) at 6-12 hours and 1, 2, and 3 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciNPT | Experimental |
| |
| Conventional tape dressings | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciNPT | Device | Following closure of the abdominal donor site, the closed incision will be dressed with the ciNPT system [V.A.C.ULTA™ Negative Pressure Wound Therapy System (KCI, USA)] applied by the operating surgeon in a sterile fashion (Figure 2). The ciNPT device will be set at -125mmHg of continuous negative pressure for a period of 7 days or until patient discharge from hospital. Removal of the ciNPT dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied to the abdominal incision unless clinically indicated secondary to dehiscence. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Abdominal Wall Dehiscence | the between-group difference in the incidence of abdominal wound dehiscence- 'wound dehiscence' will be defined as the partial or full-thickness separation of the abdominal wound incision necessitating routine dressing changes, surgical debridement, or revision of the abdominal incision | one measurement between 4-8 weeks (variable based on surgeons' routine follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Seroma Formation | defined by the presence of a symptomatic, subcutaneous fluid collection (diagnosed clinically or by ultrasound per clinician judgement) | 2 weeks, 4-8 weeks (variable based on surgeons' routine follow up) |
| Percentage of participants with Surgical Site Infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher J Coroneos, MD MSc FRCSC | Contact | 905-521-2100 | 44369 | coronec@mcmaster.ca |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29369109 | Background | Leyngold MM. Is Unipedicled Transverse Rectus Abdominis Myocutaneous Flap Obsolete Owing to Superiority of DIEP Flap? Ann Plast Surg. 2018 Jun;80(6S Suppl 6):S418-S420. doi: 10.1097/SAP.0000000000001319. | |
| 29794640 | Background | Chang EI, Liu J. Prospective Evaluation of Obese Patients Undergoing Autologous Abdominal Free Flap Breast Reconstruction. Plast Reconstr Surg. 2018 Aug;142(2):120e-125e. doi: 10.1097/PRS.0000000000004550. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013529 | Surgical Wound Dehiscence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Conventional Tape Dressings | Other | Following closure of the abdominal donor site, the closed abdominal incision will be dressed with 1-inch Micropore™ Surgical Tape (3M, USA) with an alcohol swab applied to the tape for additional adhesion, by the operating surgeon in a sterile fashion. This dressing will remain in-situ for up to 7 days or until patient discharge from hospital. Removal of the traditional tape dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied unless clinically indicated secondary to dehiscence. |
|
| DIEP Breast Reconstruction | Procedure | All patients enrolled in the study will undergo DIEP breast reconstruction and have their abdominal incision sutured according to routine clinical practice. At the Hamilton sites, we will use 3-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 4-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 5-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure. At the London sites, we will use 2-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 3-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 4-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure. |
|
necessitating antibiotic administration (diagnosed clinically or by wound swab) |
| 2 weeks, 4-8 weeks (variable based on surgeons' routine follow up) |
| 5-level EQ-5D version (EQ-5D-5L) - Patient Quality of Life | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). This scale is a patient-reported outcome measure (PROM) designed to measure overall health status. The EQ-5D measures 5 health states measured from 1-5, with 1 being the best and 5 being the worst. An overall score can be generated from this with the best health at the minimum score of 5, and the worst health state at the maximum score of 25. | 1 month, 3 month, 6 months |
| EQ-VAS | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). This scale is a patient-reported outcome measure (PROM) designed to measure overall health status. The EQ VAS is an analogue scale from 0-100, with 100 being the best health and 0 being the worst health that you can imagine | 1 month, 3 month, 6 months |
| BREAST-Q physical well-being abdomen - Patient Quality of Life | The BREAST-Q physical well-being abdomen is a patient-reported outcome measure (PROM) designed to measure the negative physical sequelae of the abdomen following autologous tissue reconstruction. Total scores are converted to an equivalent Rasch transformed score from 0 to 100. 0 represents the worst outcome and 100 represents the best outcome. | 1 month, 3 month, 6 months |
| SCAR-Q - Patient Quality of Life | The BREAST-Q physical well-being abdomen is a patient-reported outcome measure (PROM) designed to measure the the appearance, symptoms, and psychosocial impact of scars. Total scores are converted to an equivalent Rasch transformed score from 0 to 100. 0 represents the worst outcome and 100 represents the best outcome. | 1 month, 3 month, 6 months |
| Incidence of myocardial injury after non-cardiac surgery (MINS) | MINS is defined by the presence of abnormally elevated postoperative high-sensitivity troponin T (hsTnT) levels within the first 3 days after surgery | 6-12 hours, 1 day, 2 days, 3 days |
| 30126630 | Background | Muller-Sloof E, de Laat HEW, Hummelink SLM, Peters JWB, Ulrich DJO. The effect of postoperative closed incision negative pressure therapy on the incidence of donor site wound dehiscence in breast reconstruction patients: DEhiscence PREvention Study (DEPRES), pilot randomized controlled trial. J Tissue Viability. 2018 Nov;27(4):262-266. doi: 10.1016/j.jtv.2018.08.005. Epub 2018 Aug 14. |
| 31538064 | Background | Lindenblatt N, Gruenherz L, Farhadi J. A systematic review of donor site aesthetic and complications after deep inferior epigastric perforator flap breast reconstruction. Gland Surg. 2019 Aug;8(4):389-398. doi: 10.21037/gs.2019.06.05. |
| Background | World Union of Wound Healing Societies (WUWHS) Consensus Document. Surgical wound dehiscence: improving prevention and outcomes. Wounds International2018. |
| 29910106 | Background | Thacoor A, Kanapathy M, Torres-Grau J, Chana J. Deep inferior epigastric perforator (DIEP) flap: Impact of drain free donor abdominal site on long term patient outcomes and duration of inpatient stay. J Plast Reconstr Aesthet Surg. 2018 Aug;71(8):1103-1107. doi: 10.1016/j.bjps.2018.04.019. Epub 2018 May 22. |
| 25557724 | Background | Nelson JA, Chung CU, Fischer JP, Kanchwala SK, Serletti JM, Wu LC. Wound healing complications after autologous breast reconstruction: a model to predict risk. J Plast Reconstr Aesthet Surg. 2015 Apr;68(4):531-9. doi: 10.1016/j.bjps.2014.11.017. Epub 2014 Nov 28. |
| 26447018 | Background | Sandy-Hodgetts K, Watts R. Effectiveness of negative pressure wound therapy/closed incision management in the prevention of post-surgical wound complications: a systematic review and meta-analysis. JBI Database System Rev Implement Rep. 2015 Jan;13(1):253-303. doi: 10.11124/jbisrir-2015-1687. |
| 21868417 | Background | Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25. |
| 26994715 | Background | Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084. |
| 31009887 | Background | Tran BNN, Johnson AR, Shen C, Lee BT, Lee ES. Closed-Incision Negative-Pressure Therapy Efficacy in Abdominal Wall Reconstruction in High-Risk Patients: A Meta-analysis. J Surg Res. 2019 Sep;241:63-71. doi: 10.1016/j.jss.2019.03.033. Epub 2019 Apr 19. |
| 33201541 | Background | Siegwart LC, Sieber L, Fischer S, Maraka S, Kneser U, Kotsougiani-Fischer D. Influence of closed incision negative-pressure therapy on abdominal donor-site morbidity in microsurgical breast reconstruction. Microsurgery. 2022 Jan;42(1):32-39. doi: 10.1002/micr.30683. Epub 2020 Nov 17. |
| 30985328 | Background | Smilowitz NR, Redel-Traub G, Hausvater A, Armanious A, Nicholson J, Puelacher C, Berger JS. Myocardial Injury After Noncardiac Surgery: A Systematic Review and Meta-Analysis. Cardiol Rev. 2019 Nov/Dec;27(6):267-273. doi: 10.1097/CRD.0000000000000254. |
| 28444280 | Background | Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360. |
| 31095334 | Background | Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301. |
| 26978655 | Background | Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016. |
| Background | EuroQol Research Foundation. EQ-5D-5L User Guide, 2019. Available from: https://euroqol.org/publications/user-guides. |
| Background | BREAST-Q Version 2.0 A Guide for Researchers and Clinicians [Internet]. Qportfolio.org. 2017 [cited 18 January 2021]. Available from: http://qportfolio.org/wp-content/uploads/2020/02/BREAST-Q-USERS-GUIDE-V2.pdf. |
| Background | SCAR-Q USER'S GUIDE VERSION 1.0 [Internet]. Qportfolio.org. 2018 [cited 18 January 2021]. Available from: http://qportfolio.org/wp-content/uploads/2020/02/SCAR-Q-USERS-GUIDE-V1.pdf. |
| 21479777 | Background | Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9. |
| 33173657 | Background | Thoma A, Avram R, Dal Cin A, Murphy J, Duku E, Xie F. Cost-effectiveness Analysis of Abdominal-based Autogenous Tissue and Tissue-expander Implant following Mastectomy. Plast Reconstr Surg Glob Open. 2020 Apr 11;8(10):e2986. doi: 10.1097/GOX.0000000000002986. eCollection 2020 Oct. |
| 33173691 | Background | Thoma A, Avram R, Dal Cin A, Murphy J, Duku E, Xie F. Comparing the Clinical and Cost-Effectiveness of Abdominal-based Autogenous Tissue and Tissue-Expander Implant: A Feasibility Study. Plast Reconstr Surg Glob Open. 2020 Apr 11;8(10):e3179. doi: 10.1097/GOX.0000000000003179. eCollection 2020 Oct. |
| Background | 2019 Plastic Surgery Statistics Report [Internet]. Plasticsurgery.org. 2019 [cited 8 December 2020]. Available from: https://www.plasticsurgery.org/documents/News/Statistics/2019/plastic-surgery-statistics-full-report-2019.pdf. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |