An interventional study of Prophylactic negative pressure wound dressing after laparotomy in Surgical Wound, Wound Dehiscence, Surgical and Surgical Site Infection, sponsored by St. Borbala Hospital. Terminated at 1 site in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by St. Borbala Hospital · Not applicable, Interventional, and Prevention
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.
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →St. Borbala Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Prophylactic negative pressure wound dressing after laparotomy
Control group with traditional, dry laparotomy wound dressing.
Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.
Surgical site infection
Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)
Time frame: 30 days
Full thickness abdominal wall dehiscence, requiring re-operation
Full thickness abdominal wall dehiscence, requiring re-operation
Time frame: 30 days
Plan to share: No
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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St. Borbala Hospital