Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

Overview

Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen. NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness. In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

Full Title of Study: “Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2020

Detailed Description

The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds. Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress. Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag – Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam – Hartmann) and sufficient-size sealant film (Hydrofilm® – Hartmann). A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively. Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Interventions

  • Device: Prophylactic negative pressure wound dressing after laparotomy
    • Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.

Arms, Groups and Cohorts

  • Experimental: ciNPWT
    • Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation. Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed.
  • No Intervention: Traditional wound dressing
    • Control group with traditional, dry laparotomy wound dressing.

Clinical Trial Outcome Measures

Primary Measures

  • Surgical site infection
    • Time Frame: 30 days
    • Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)

Secondary Measures

  • Full thickness abdominal wall dehiscence, requiring re-operation
    • Time Frame: 30 days
    • Full thickness abdominal wall dehiscence, requiring re-operation

Participating in This Clinical Trial

Inclusion Criteria

  • High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%) – Surgical wound type III or IV.. Exclusion Criteria:

  • Patients not giving informed consent. – Patients requiring open abdominal wound care. – Patients with abdominal wall malignancy, – Patients with peritoneal carcinomatosis, – Patients who are planned for second look laparotomy within 5 days, – Patients with less thank 3 month life expectancy. – Patients who are operated with existing wound infection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Borbala Hospital
  • Collaborator
    • Semmelweis University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Balázs Bánky PhD, Head of the Department of Surgery, St. Borbala Hospital – St. Borbala Hospital

Citations Reporting on Results

Sahebally SM, McKevitt K, Stephens I, Fitzpatrick F, Deasy J, Burke JP, McNamara D. Negative Pressure Wound Therapy for Closed Laparotomy Incisions in General and Colorectal Surgery: A Systematic Review and Meta-analysis. JAMA Surg. 2018 Nov 1;153(11):e183467. doi: 10.1001/jamasurg.2018.3467. Epub 2018 Nov 21.

Curran T, Alvarez D, Pastrana Del Valle J, Cataldo TE, Poylin V, Nagle D. Prophylactic closed-incision negative-pressure wound therapy is associated with decreased surgical site infection in high-risk colorectal surgery laparotomy wounds. Colorectal Dis. 2019 Jan;21(1):110-118. doi: 10.1111/codi.14350. Epub 2018 Aug 20.

Gachabayov M, You K, Sullivan R, Bergamaschi R. A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery. Ostomy Wound Manage. 2018 Apr;64(4):22-29.

Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.

Athanasiou AN, Spartalis M, Spartalis E. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds After Abdominal Operations: What We Really Know? Ann Surg. 2018 Jul;268(1):e19-e20. doi: 10.1097/SLA.0000000000002413. No abstract available.

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