Clinical trial NCT03716687: Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.
Official title: Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. Randomized Prospective Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Wound
Wound Dehiscence, Surgical
Surgical Site Infection
Dehiscence of Internal Surgical Wound
Keywords: negative pressure wound closure
surgical site infection
cost effectiveness
Lead sponsor: St. Borbala Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Semmelweis University
name: Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest
name: Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár
name: Institute of Surgery, University of Debrecen
name: Department of Surgery, University of Szeged
name: Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest
name: Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely
name: Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét
name: Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen
name: Department of Surgery, Szent Rókus Kórház, Baja
name: Department of Surgery, St. Borbala hospital, Tatabanya
First posted: 2018-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50-50% randomisation into interventional (ciNPWT) and control (traditionaltreatment) groups.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: Full thickness abdominal wall dehiscence, requiring re-operation
timeFrame: 30 days
Other outcomes:
Locations:
city: Tatabánya
country: Hungary
facility: St. Borbala Hospital
Study officials:
References:
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):e183467. doi: 10.1001/jamasurg.2018.3467. Epub 2018 Nov 21.
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. 2019 Jan;21(1):110-118. doi: 10.1111/codi.14350. Epub 2018 Aug 20.
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.
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.2017.156. Epub 2017 Sep 8.
citation: 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.