Study Summary
This trial is testing whether a closed incision negative pressure dressing (PREVENA) can reduce wound complications and medical costs in patients undergoing lower extremity amputation.
- Amputation Sequelae
- Seroma
- Postoperative Wound Infection
- Amputation
- Lymphatic Leakage
- Wound Separation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 30 days post procedure
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard Care
1 of 2
Prevena
1 of 2
Active Control
Experimental Treatment
440 Total Participants · 2 Treatment Groups
Primary Treatment: PREVENA™ PEEL & PLACE™ Dressing Kit · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Hasanadka R, McLafferty RB, Moore CJ, Hood DB, Ramsey DE, Hodgson KJ. Predictors of wound complications following major amputation for critical limb ischemia. J Vasc Surg. 2011 Nov;54(5):1374-82. doi: 10.1016/j.jvs.2011.04.048. Epub 2011 Aug 15.
- Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.
- Grauhan O, Navasardyan A, Hofmann M, Müller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
- Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1.
- Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.
- Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.
- Berry, Donald A., and Larry M. Pearson. 1985. “Optimal Designs for Clinical Trials with Dichotomous Responses”. Statistics in Medicine. Wiley. doi:10.1002/sim.4780040410.
- Hyldig, N, H Birke-Sorensen, M Kruse, C Vinter, J S Joergensen, J A Sorensen, O Mogensen, R F Lamont, and C Bille. 2016. “Meta-analysis of Negative-pressure Wound Therapy for Closed Surgical Incisions”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.10084.
- 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.
- Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
- 2019. "Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03773575.
Frequently Asked Questions
How many medical facilities are engaged in the implementation of this trial?
"Currently, 4 sites are welcoming participants into this trial. These include Philadelphia and Abington as well as Valhalla with additional locations available. It is encouraged to select the closest site in order to minimize any travel burden associated with participation." - Anonymous Online Contributor
How many participants has the clinical trial been able to recruit?
"Affirmative. According to the clinicaltrials.gov database, this research endeavour is presently in search of participants and is targeting 440 people from 4 distinct medical centres. It was first published on January 15th 2019 with its most recent update occurring November 3rd 2021." - Anonymous Online Contributor
Is there still an opportunity to join this experiment?
"Affirmative. As per the information published on clinicaltrials.gov, this research endeavour is actively looking for enrollees. It was initially posted online on January 15th 2019 and revised most recently in November 2021. The project aims to recruit a total of 440 individuals from 4 distinct medical centres." - Anonymous Online Contributor