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. A Randomized Prospective Clinical Trial.

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

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

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.

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

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.

Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.

Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)

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

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