Clinical Trial of a Silver Eluting Dressing System

NCT01229358 | Completed Phase 4

• 1 other identifier: 2010-P-001149/1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

This prospective, multi-institutional randomized clinical trial of a silver ion eluting dressing material compared to standard dry gauze for closed skin incisions after open surgical revascularizations for peripheral vascular occlusive disease. Based on the ability of the silver to lower the bacterial contamination of these vulnerable surgical skin incisions, the investigators hypothesize that immediate application of Acticoat Absorbent® as a post-operative dressing will reduce closed incisional wound complications in patients undergoing lower extremity revascularizations involving infrainguinal skin incisions compared to standard non-silver eluting dressing material.

Conditions

Vascular Disease; Surgery

Keywords

vascular surgery; wound infection; wound complication

Outcome Measures

Primary Outcomes (1)

• Wound complication

  * No Wound Complication * Superficial Incisional SSI: Infection that occurs within 30 days after the operation and infection involves only skin/ SQ tissue of the incision * Deep Incisional SSI: Infection that occurs within 30 days after operation and infection appears to be related to the operation and infection involved deep tissues (fascial/muscle layers) of the incision * Other (seroma, lymphocele, hematoma, etc)

  Within 30 days of index procedure

Study Arms (2)

Silver Eluting Dressing

EXPERIMENTAL

Acticoat Absorbant™ applied as post-operative dressing

Other: Surgical dressing

Standard Guaze

ACTIVE COMPARATOR

Standard dry gauze applied as post-operative dressing

Other: Surgical dressing

Interventions

Surgical dressing OTHER

Acticoat Absorbant™ vs standard dry gauze as the immediate post operative dressing

Also known as: Acticoat Absorbant™, Silver dressing

Silver Eluting Dressing; Standard Guaze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient capable of informed consent who completes consent process
• Undergoing open (an incision below inguinal ligament) surgical procedure for peripheral arterial vascular disease in which it is anticipated that the incisions will be closed. Open cases combined with endovascular approaches acceptable.

You may not qualify if:

• Age less than 18
• Known allergy to silver or alginate
• Participation in another interventional clinical trial

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Michael Debakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Childress BB, Berceli SA, Nelson PR, Lee WA, Ozaki CK. Impact of an absorbent silver-eluting dressing system on lower extremity revascularization wound complications. Ann Vasc Surg. 2007 Sep;21(5):598-602. doi: 10.1016/j.avsg.2007.03.024. Epub 2007 May 23.

  PMID: 17521872 BACKGROUND

• Nguyen LL, Brahmanandam S, Bandyk DF, Belkin M, Clowes AW, Moneta GL, Conte MS. Female gender and oral anticoagulants are associated with wound complications in lower extremity vein bypass: an analysis of 1404 operations for critical limb ischemia. J Vasc Surg. 2007 Dec;46(6):1191-1197. doi: 10.1016/j.jvs.2007.07.053.

  PMID: 18154995 BACKGROUND

• Khuri SF, Daley J, Henderson W, Hur K, Demakis J, Aust JB, Chong V, Fabri PJ, Gibbs JO, Grover F, Hammermeister K, Irvin G 3rd, McDonald G, Passaro E Jr, Phillips L, Scamman F, Spencer J, Stremple JF. The Department of Veterans Affairs' NSQIP: the first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg. 1998 Oct;228(4):491-507. doi: 10.1097/00000658-199810000-00006.

  PMID: 9790339 BACKGROUND

• Kent KC, Bartek S, Kuntz KM, Anninos E, Skillman JJ. Prospective study of wound complications in continuous infrainguinal incisions after lower limb arterial reconstruction: incidence, risk factors, and cost. Surgery. 1996 Apr;119(4):378-83. doi: 10.1016/s0039-6060(96)80135-8.

  PMID: 8644000 BACKGROUND

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

• Ozaki CK, Hamdan AD, Barshes NR, Wyers M, Hevelone ND, Belkin M, Nguyen LL. Prospective, randomized, multi-institutional clinical trial of a silver alginate dressing to reduce lower extremity vascular surgery wound complications. J Vasc Surg. 2015 Feb;61(2):419-427.e1. doi: 10.1016/j.jvs.2014.07.034. Epub 2014 Aug 28.

  PMID: 25175629 DERIVED

MeSH Terms

Conditions

Vascular Diseases; Wound Infection

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Infections

Study Officials

• C Keith Ozaki, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (3)