Clinical & Economic Validation
The versatility of the Progel® technology platform lends itself to the development of new product formulations – targeted at specific surgical specialties. Progel Pleural Air Leak Sealant is clinically proven to effectively seal intraoperative air leaks of the lungs and reduce hospital length of stay.
The following are key clinical studies and publications evaluating the clinical efficacy and cost savings of Neomend’s first commercially available, FDA approved product in the US, ProgelPleural Air Leak Sealant.
Prospective randomized study evaluating a biodegradable polymeric sealant for sealing intraoperative air leaks that occur during pulmonary resection
Mark S. Allen, Douglas E. Wood, Ronald W. Hawkinson, David H. Harpole, Robert J. McKenna, Garrett L. Walsh, Eric Vallieres, Daniel. L. Miller, Francis C. Nichols, III, W. Roy Smythe and Robert D. Davis
Annals of Thoracic Surgery 2004;77:1792-1801
Study Design:
Prospective, randomized (2:1), controlled, multicenter trial, 273 patients enrolled, 161 patients randomizedKey Endpoints (Progel group vs. control):
61% increase in successfully sealed intraoperative air leaks
21% increase in successfully sealed patients remaining air leak free through 1 month follow-up
1.9 days mean reduction in length of stay (1 day median)
Assessment of the Clinical and Economic Impact of Air Leaks During Post-operative Pulmonary Surgery
Eric Gemmen1, Benjamin Smith2, John Doyle2, John Proach43, John Long3, William Garvert1
1. Quintiles, Inc., Rockville, MD, USA, 2. Quintiles Global Consulting, Hawthorne, NY, USA, 3. Triage HealthCom, Princeton, NJ, USA
Presented at the 2010 15th Annual International Society for Pharmacoeconomics and Outcomes Research Meeting
Study Design:
Retrospective review of 2006 Nationwide Inpatient Sample (NIS) data, 77,117 inpatient stays, 15.3% with air leakKey Endpoints:
3.5 day mean increase in length of stay for patients with air leak
$14,926 mean increase in total hospital cost for patients with air leak
1.27 times increase in likelihood of in-hospital mortality for patients with an air leak
What Is The Inpatient Cost of Hospital Complications or Death After Lobectomy or Pneumonectomy?
John R. Handy, Jr, Kelly Denniston, Gary L. Grunkemeir and Ying Xing Wu
Annals of Thoracic Surgery 2011;91;234-238
Study Design:
Retrospective, single-center review, 294 patients, 53 patients with at least 1 major complication or deathKey Endpoints:
$11, 693 cost increase for patients with 1 complication
$26,673 cost increase for patients with 2 complications
$128,450 cost increase for patients with 3 complications
$49, 823 cost increase for patient death
For full prescribing information, including indications, effects, routes, methods, frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, please review the Instructions for Use.