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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03716687
• Other study ID #: OGYÉI/15347-9/2018
• Status: Terminated
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2021
• Source: St. Borbala Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: September 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehiscence of Internal Surgical Wound
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Dehiscence
• Surgical Wound Infection
• Wound Dehiscence, Surgical
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Hungary	St. Borbala Hospital	Tatabánya

Sponsors (12)

Lead Sponsor

Collaborator

St. Borbala Hospital

Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét, Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelointézet, Budapest, Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen, Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely, Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár, Department of Surgery, St. Borbala hospital, Tatabanya, Department of Surgery, Szent Rókus Kórház, Baja, Department of Surgery, University of Szeged, Department of Surgery, Uzsoki Utcai Kórház és Rendelointézet, Budapest, Institute of Surgery, University of Debrecen, Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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):e18 — View Citation

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.2017.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)	30 days
Secondary	Full thickness abdominal wall dehiscence, requiring re-operation	Full thickness abdominal wall dehiscence, requiring re-operation	30 days