- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907941
ciNPT in Autologous DIEP Flap Breast Reconstruction
Closed Incision Negative Pressure Therapy Compared to Conventional Dressing Following Autologous Abdominal Tissue Breast Reconstruction: A Randomized Control Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher J Coroneos, MD MSc FRCSC
- Phone Number: 44369 905-521-2100
- Email: coronec@mcmaster.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult female patients (≥ 18 years old)
- consent to elective immediate (i.e. performed at the time of mastectomy) or delayed (i.e. performed following mastectomy) breast reconstruction using the DIEP flap
Exclusion Criteria:
- patients who are pregnant
- have a documented/reported allergy to adhesive dressings
- Body mass index (BMI) ≥ 40 kg/m2
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ciNPT
|
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.
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.
|
Active Comparator: Conventional tape dressings
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants with Abdominal Wall Dehiscence
Time Frame: one measurement between 4-8 weeks (variable based on surgeons' routine follow up)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BREAST-Q physical well-being abdomen - Patient Quality of Life
Time Frame: 1 month, 3 month, 6 months
|
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
Time Frame: 1 month, 3 month, 6 months
|
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)
Time Frame: 6-12 hours, 1 day, 2 days, 3 days
|
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
|
Percentage of participants with Seroma Formation
Time Frame: 2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)
|
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
Time Frame: 2 weeks, 4-8 weeks (variable based on surgeons' routine follow up)
|
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
Time Frame: 1 month, 3 month, 6 months
|
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
Time Frame: 1 month, 3 month, 6 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- World Union of Wound Healing Societies (WUWHS) Consensus Document. Surgical wound dehiscence: improving prevention and outcomes. Wounds International2018.
- 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.
- EuroQol Research Foundation. EQ-5D-5L User Guide, 2019. Available from: https://euroqol.org/publications/user-guides.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16422
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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