NCT03716687

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: St. Borbala Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Surgical Wound
• Wound Dehiscence, Surgical
• Surgical Site Infection
• Dehiscence of Internal Surgical Wound

Interventions

Type	Name	Description
DEVICE	Prophylactic negative pressure wound dressing after laparotomy	Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-07-01
• Completion: 2020-09-01
• First posted: 2018-10-23
• Last updated: 2021-03-22

Locations

1 site across 1 country: Hungary