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Post-operative wound complications in abdominal surgery have a major impact on patient outcomes and the real impact of Closed incision negative pressure therapy (CINVt) is not clear in the literature moreover concerning its potential economic benefits The hypothesis of this study is that CINPt has the potential to reduce Surgical Site Infections.
Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.
Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the most frequent wound occurrences are represented by wound infections, skin dehiscence or parietal hernias.
Despite standard surgical aseptically technique and perioperative prevention management of infections (e.g. antibiotics), wound complications after emergency laparotomies are still an important unmet challenge.
Moreover, all these complications increase the cost of care requiring new managements.
CINPt has been longly used to favour the successful healing of a plethora of open wounds.
In particular CINPt is based on the application of local negative pressure to the wound surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed central foam, which is placed on the surface of the viscera. Then, two layers of porous sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is placed over the foam and the wound to seal the abdominal cavity. The entire system is then connected, by suction tubes, to a device which ubiquitously applies negative pressure (cyclically or continuously) on the surface. The fluid from the wound is collected into a container. The benefits of negative pressure wound therapy have been reported to include removal of infectious material, reduction in oedema and improved perfusion to tissue. Since few years, a new negative pressure wound therapy has been created for closed wounds to reduce time of healing and avoid wound complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREVENA (CiPNT) | Experimental | Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply all parts just after the surgical procedure. A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators. The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital. The specialized nurse who will take a photo and assess the condition of the wound in the treatment room. One of the investigators, non-operators, who will also assess the condition of the wound by photo. |
|
| Simple dressing | Active Comparator | Simple dressing; standard, waterproof dressing applied to wound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies | Device | Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply the PREVENA just after the surgical procedure. A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators. The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital. The specialized nurse who will take a photo and assess the condition of the wound in the treatment room. One of the investigators, non-operators, who will also assess the condition of the wound by photo. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if the use of prophylactic negative-pressure wound therapy (Prevena) reduces the incidence of superficial surgical site infection after emergency laparotomy in patients at high-risk for SSI | Any SSI may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Superficial site infection will be assessed by Wound Classification System Using the American College of Surgeons National Surgical Quality Improvement Program ACS-NSQIP :
| up to 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay (LOS) in days. | LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complications. | 30 days post procedure |
| 30-day Return to Operating Room (ROR) |
| Measure | Description | Time Frame |
|---|---|---|
| A rate of parietal incisional hernia apparition after surgery | This complication rate is multifactorial can be related to:
| 2 years post procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziad Abbassi, M.D. | Contact | 0041766931667 | Ziad.abbassi@hcuge.ch | |
| Jérémy Meyer, Ph.D. | Contact | 0041763161984 | Jeremy.meyer@hcuge.ch |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22868327 | Result | Conde-Green A, Chung TL, Holton LH 3rd, Hui-Chou HG, Zhu Y, Wang H, Zahiri H, Singh DP. Incisional negative-pressure wound therapy versus conventional dressings following abdominal wall reconstruction: a comparative study. Ann Plast Surg. 2013 Oct;71(4):394-7. doi: 10.1097/SAP.0b013e31824c9073. | |
| 26026135 | Result |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D049291 | Seroma |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation. |
| 30 days post procedure |
| Incidence rates of wound complications | Individual rates of the incidence of each of the following: dehiscence (skin or fascia), seroma, lymph leak, infection, hematoma, ischemia and necrosis. | 30 days post procedure |
| Gorgulu T. A Complication of Management of Closed Incision with Negative-Pressure Wound Therapy. Aesthet Surg J. 2015 Jul;35(5):NP113-5. doi: 10.1093/asj/sju120. Epub 2015 May 29. No abstract available. |
| 24754343 | Result | Dohmen PM, Misfeld M, Borger MA, Mohr FW. Closed incision management with negative pressure wound therapy. Expert Rev Med Devices. 2014 Jul;11(4):395-402. doi: 10.1586/17434440.2014.911081. Epub 2014 Apr 22. |
| 24106562 | Result | Ingargiola MJ, Daniali LN, Lee ES. Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Eplasty. 2013 Sep 20;13:e49. eCollection 2013. |
| 21868417 | Result | Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25. |
| 23231938 | Result | Vargo D. Negative pressure wound therapy in the prevention of wound infection in high risk abdominal wound closures. Am J Surg. 2012 Dec;204(6):1021-3; discussion 1023-4. doi: 10.1016/j.amjsurg.2012.10.004. |
| 27416813 | Result | Zaidi A, El-Masry S. Closed-incision negative-pressure therapy in high-risk general surgery patients following laparotomy: a retrospective study. Colorectal Dis. 2017 Mar;19(3):283-287. doi: 10.1111/codi.13458. |
| 28717587 | Result | Gunatilake RP, Swamy GK, Brancazio LR, Smrtka MP, Thompson JL, Gilner JB, Gray BA, Heine RP. Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial. AJP Rep. 2017 Jul;7(3):e151-e157. doi: 10.1055/s-0037-1603956. Epub 2017 Jul 14. |
| 19911098 | Result | Reddix RN Jr, Tyler HK, Kulp B, Webb LX. Incisional vacuum-assisted wound closure in morbidly obese patients undergoing acetabular fracture surgery. Am J Orthop (Belle Mead NJ). 2009 Sep;38(9):446-9. |
| 21804414 | Result | Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5. |
| 25125244 | Result | Pauser J, Nordmeyer M, Biber R, Jantsch J, Kopschina C, Bail HJ, Brem MH. Incisional negative pressure wound therapy after hemiarthroplasty for femoral neck fractures - reduction of wound complications. Int Wound J. 2016 Oct;13(5):663-7. doi: 10.1111/iwj.12344. Epub 2014 Aug 14. |
| 28705547 | Result | Redfern RE, Cameron-Ruetz C, O'Drobinak SK, Chen JT, Beer KJ. Closed Incision Negative Pressure Therapy Effects on Postoperative Infection and Surgical Site Complication After Total Hip and Knee Arthroplasty. J Arthroplasty. 2017 Nov;32(11):3333-3339. doi: 10.1016/j.arth.2017.06.019. Epub 2017 Jun 17. |
| 23539123 | Result | Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3. |
| 26313829 | Result | Semsarzadeh NN, Tadisina KK, Maddox J, Chopra K, Singh DP. Closed Incision Negative-Pressure Therapy Is Associated with Decreased Surgical-Site Infections: A Meta-Analysis. Plast Reconstr Surg. 2015 Sep;136(3):592-602. doi: 10.1097/PRS.0000000000001519. |
| 27844201 | Result | Wiegering A, Dietz UA, Corteville C, Plassmeier L, Jurowich C, Germer CT, Krajinovic K. Impact of incisional negative pressure wound therapy on perineal wound healing after abdominoperineal rectum extirpation. Int J Colorectal Dis. 2017 Feb;32(2):291-293. doi: 10.1007/s00384-016-2704-5. Epub 2016 Nov 14. |
| 24201395 | Result | Bonds AM, Novick TK, Dietert JB, Araghizadeh FY, Olson CH. Incisional negative pressure wound therapy significantly reduces surgical site infection in open colorectal surgery. Dis Colon Rectum. 2013 Dec;56(12):1403-8. doi: 10.1097/DCR.0b013e3182a39959. |
| 30912582 | Result | Webster J, Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD009261. doi: 10.1002/14651858.CD009261.pub4. |
| 31592899 | Result | Zwanenburg PR, Tol BT, Obdeijn MC, Lapid O, Gans SL, Boermeester MA. Meta-analysis, Meta-regression, and GRADE Assessment of Randomized and Nonrandomized Studies of Incisional Negative Pressure Wound Therapy Versus Control Dressings for the Prevention of Postoperative Wound Complications. Ann Surg. 2020 Jul;272(1):81-91. doi: 10.1097/SLA.0000000000003644. |
| 25554246 | Result | Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, Shekelle P, Stewart LA; PRISMA-P Group. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015 Jan 1;4(1):1. doi: 10.1186/2046-4053-4-1. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
| D006470 | Hemorrhage |