Prospective Observation of Wound Healing With Prevena Incision Management System

• Sponsor: University of California, Irvine (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01704924
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 50
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study aims to assess the quality of wound healing in abdominal scars with and without the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved wound healing with less swelling, bruising, and inflammation, as well as less potential for infection, seroma, and dehiscence.

Condition or Disease	Intervention/Treatment	Phase
Scarring	Device: Prevena; Procedure: Standard of Care Dressing	N/A

Detailed Description

The quality of wound healing can be of the utmost importance for patients undergoing large abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease seroma and infection rates in high risk patients. This study aims to quantify the effect, if any, that negative pressure wound therapy has on closed incisions. The technology may provide benefits even in lower risk patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Prospective Observation of Wound Healing With Prevena Incision Management System
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prevena Incision with prevena device overlying	Device: Prevena; Device will be applied at end of procedure over closed incision
Active Comparator: Standard of Care dressing Prevena device is not used	Procedure: Standard of Care Dressing; Dressing applied as Standard of Care

Outcome Measures

Primary Outcome Measures

1. Scarring [0-6 months]

   Assess quality of scar: hypertrophy, hyperpigmentation, etc

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• abdominal procedure with incision >20cm

• must be >18 years of age

Exclusion Criteria:

• <18 years of age

• history of allergy or reaction to adhesives

• pregnant or anticipated pregnancy within 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at Irvine	Orange	California	United States	92868

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: Gregory Evans, MD, The University of California Irvine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Prevena Product Website

Publications

• 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.
• 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.

• Responsible Party: Gregory R. Evans, Professor, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT01704924
• Other Study ID Numbers: KCI-2011-8268
• First Posted: Oct 12, 2012
• Last Update Posted: Jan 19, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Gregory R. Evans, Professor, University of California, Irvine: Prevena; negative pressure wound therapy; Incisional wound vac
• Additional relevant MeSH terms: Cicatrix

Study Results

No Results Posted as of Jan 19, 2018