Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

Amputation Clinical Trial

— PREVENA-AMP  

Official title:

Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773575
• Other study ID #: 18P.577
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: August 15, 2024

Study information

• Verified date: May 2023
• Source: Thomas Jefferson University
• Contact: Melissa McCarey
• Phone: 215-503-7417
• Email: Melissa.McCarey[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.

Description:

This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: August 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adults 18 years or older

2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)

3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)

4. Informed Consent signed by patient

Exclusion Criteria:

1. Minors under 18 years

2. Women who are pregnant or breastfeeding

3. Patients undergoing emergent or guillotine amputation

4. Patients having BOTH legs amputated

5. Patients with sensitivity to silver

6. Unwilling or unable to provide informed consent

7. Inability to comply with planned study procedures

Related Conditions & MeSH terms

• Amputation
• Amputation; Postoperative, Sequelae
• Lymph Leakage
• Seroma
• Surgical Wound Infection
• Wound Dehiscence
• Wound Infection
• Wound Infection, Surgical
• Wounds and Injuries

Intervention

Device:
• PREVENA™ PEEL & PLACE™ Dressing Kit
In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).

Locations

Country	Name	City	State
Italy	Gemelli Hospital	Roma	RM
United States	Thomas Jefferson University/Hospital	Philadelphia	Pennsylvania
United States	Westchester Medical Center	Valhalla	New York

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Acelity

Countries where clinical trial is conducted

United States,  Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30-day hospitalization costs	Index hospitalization costs as well as all readmission days within 30d related to any wound complication	admission to discharge; 30 days post procedure
Other	30-day hospital variable costs	Variable costs (not charges) for each admission obtained from hospital administration	admission to discharge; 30 days post procedure
Primary	Overall rate of wound complications	Presence of any of the following post-procedure: Dehiscence (skin or fascia); Seroma; Lymph leak; Infection (superficial or deep, using CDC Surgical Site Infection criteria); Hematoma; Ischemia; Necrosis	30 days post procedure
Secondary	Length of stay (LOS)	index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication	30 days post procedure
Secondary	30-day Return to Operating Room (ROR)	Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation	30 days post procedure
Secondary	30-day hospital readmissions	Rehospitalization for wound complication within 30 days	30 days post procedure
Secondary	Incidence rates of wound complications	Individual rates of the incidence of each of the following: Dehiscence (skin or fascia); Seroma; Lymph leak; Infection (superficial or deep, using CDC Surgical Site Infection criteria); Hematoma; Ischemia; Necrosis	30 days post procedure

External Links

•   National Healthcare Safety Network definition of Surgical Site Infection (SSI) Event