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No chance to enroll sufficient cases. Several coinvestigator centers have never started recruiting.
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| Name | Class |
|---|---|
| Semmelweis University | OTHER |
| Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest | UNKNOWN |
| Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciNPWT | Experimental | 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. |
|
| Traditional wound dressing | No Intervention | Control group with traditional, dry laparotomy wound dressing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic negative pressure wound dressing after laparotomy | Device | Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Full thickness abdominal wall dehiscence, requiring re-operation | Full thickness abdominal wall dehiscence, requiring re-operation | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Borbala Hospital | Tatabánya | 2800 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30267040 | Result | 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. | |
| 30047611 | Result |
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| Institute of Surgery, University of Debrecen | UNKNOWN |
| Department of Surgery, University of Szeged | UNKNOWN |
| Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest | UNKNOWN |
| Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely | UNKNOWN |
| Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét | UNKNOWN |
| Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen | UNKNOWN |
| Department of Surgery, Szent Rókus Kórház, Baja | UNKNOWN |
| Department of Surgery, St. Borbala hospital, Tatabanya | UNKNOWN |
50-50% randomisation into interventional (ciNPWT) and control (traditionaltreatment) groups.
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| 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. |
| 29718814 | Result | 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. |
| 28885895 | Result | 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. |
| 28692475 | Result | 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. |
| 40605477 | Derived | Herczeg A, Szijarto A, Fulop A, Varga K, Marton J, Loderer Z, Mohos B, Pancel B, Szendrenyi V, Lazar G, Libor L, Kaposztas Z, Mathe E, Bursics A, Kecskedi B, Sikorszki L, Venczel L, Banky B. Prophylactic Negative Pressure Wound Therapy Reduces Superficial Surgical Site Infection Risk of Emergency Surgery Patients: Results of a Multicenter Randomised Prospective Clinical Trial. Int Wound J. 2025 Jul;22(7):e70718. doi: 10.1111/iwj.70718. |
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D013529 | Surgical Wound Dehiscence |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |
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