Negative Pressure Incision Management System in Infrainguinal Vascular Surgery

NCT03395613 | Unknown DMC FDA Device

• 1 other identifier: ADaryapeyma
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with encouraging results and is now an accepted element in the arsenal of tools for treating these complications. The concept of applying NPWT to closed surgical wounds as a preventive measure is relatively new but draws on the inherent properties of the method which could theoretically lead to reduced seroma formation, wound dehiscence, increased capillary circulation and consequently better wound healing and fewer SSI. Given the incidence and the consequences of SSI in infrainguinal vascular procedures any appreciable decrease in the burden of these complications could have profound benefits for patients and healthcare facilities. As to date, there are no published data from randomized controlled trials investigating the effectiveness of this prophylactic measure. The aim of this study is to assess the effect of NPWT applied to closed surgical wounds directly after skin closure compared to standard sterile gauze dressing in reducing the incidence and severity of postoperative SSI in infrainguinal surgical wounds in patients undergoing elective, open vascular surgery.

Conditions

Postoperative Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Postoperative surgical site infection (SSI) within 30 days.

  SSI classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.

  30 days

Secondary Outcomes (8)

• Postoperative SSI within 90 days

  90 days

• Antibiotic prescriptions for skin and soft tissue infections within 90 days postoperatively.

  90 days

• Postoperative SSI within 90 days requiring surgical revision.

  90 days

• Adverse events directly related the NPWT dressing leading discontinuation of treatment.

  7 dats

• Major lower limb amputation and/or mortality within 90 days postoperatively.

  90 days

Study Arms (2)

Standard management

NO INTERVENTION

Standard sterile gauze dressing on surgical groin wound.

NPWT management

EXPERIMENTAL

Negative Pressure Wound Therapy dressing on surgical groin wound.

Device: NPWT

Interventions

NPWT DEVICE

Negative pressure wound thearpy on closed surgical wounds

Also known as: Prevena

NPWT management

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• The clinical criterion for study entry is elective:
• a. Open infrainguinal vascular surgery for peripheral arterial disease
• i. Thrombendarterectomy (TEA) ii. Bypass surgery with vein or synthetic graft
• Patients on whom complete seal of NPWT can be maintained during the first 24 hours after operation.

You may not qualify if:

• All emergency cases.
• Infrainguinal endovascular procedures.
• Pre-existing groin infections.
• Sensitivity/allergy to materials used in NPWT dressing.
• Patients on whom an adequate and complete seal of NPWT dressing cannot be obtained.
• Unwillingness to participate. -

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Stockholm South General Hospital: collaborator

Study Sites (1)

Karolinska university Hospital

Stockholm, 17176, Sweden

RECRUITING

Related Publications (19)

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  PMID: 19954920 RESULT

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  PMID: 8644000 RESULT

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  PMID: 19398246 RESULT

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  PMID: 24189008 RESULT

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  PMID: 1106243 RESULT

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  PMID: 3680994 RESULT

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  PMID: 1928157 RESULT

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  PMID: 12522701 RESULT

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  PMID: 21315998 RESULT

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  PMID: 12594881 RESULT

• Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.

  PMID: 20356703 RESULT

• Weed T, Ratliff C, Drake DB. Quantifying bacterial bioburden during negative pressure wound therapy: does the wound VAC enhance bacterial clearance? Ann Plast Surg. 2004 Mar;52(3):276-9; discussion 279-80. doi: 10.1097/01.sap.0000111861.75927.4d.

  PMID: 15156981 RESULT

• Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.

  PMID: 23312938 RESULT

• 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.

  PMID: 26994715 RESULT

• Daryapeyma A, Hammar U, Wahlgren CM. Incidence of Healthcare Associated Infections After Lower Extremity Revascularization Using Antibiotic Treatment as a Marker. Eur J Vasc Endovasc Surg. 2016 May;51(5):690-5. doi: 10.1016/j.ejvs.2015.12.016. Epub 2016 Feb 20.

  PMID: 26905472 RESULT

• Daryapeyma A, Nilsson O, Pettersson J, Stackelberg O, Torbjornsson E, Hultgren R. Prophylactic use of incisional negative pressure wound therapy for groin incisions in vascular surgery: randomized clinical trial. BJS Open. 2025 May 7;9(3):zraf059. doi: 10.1093/bjsopen/zraf059.

  PMID: 40500745 DERIVED

Study Officials

• Alireza Daryapeyma, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Preoperative randomization

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 10, 2018
• Study Start: January 22, 2018
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)