Surgical Site Infection Clinical Trial
— CiPNT/SSIOfficial title:
Standard Wound Dressing Versus Prophylactic Negative-pressure Wound Therapy After Emergency Laparotomy: a Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 334 |
Est. completion date | September 1, 2025 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient - =10cm emergency median laparotomy - Abdominal wall and skin closure in first intent - Septic peritoneal cavity (purulent and/or fecaloid free liquid and/or abscess) - Informed written consent Exclusion Criteria: - No abdominal wound closure in first intent - Allergy or hypersensitivity to silver - Application of a mesh for abdominal wall closure - Patients under corticosteroids or other immunosuppressive treatment. - Women who are pregnant or breast-feeding. - Intention to become pregnant during the course of the study. - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. - Previous enrolment in the current study. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Hospital, Geneva | Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva., Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva., Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva., Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva., Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva. |
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. — View Citation
Condé-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):3 — View Citation
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. Review. — View Citation
Görgülü 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. — View Citation
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 — View Citation
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/s11999-0 — View Citation
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. — View Citation
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. doi: 10.1186/2046-40 — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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:CD009261. doi: 10.1002/14651858.CD00926 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | A rate of parietal incisional hernia apparition after surgery | This complication rate is multifactorial can be related to:
An wall abcess Obesity with a BMI > 35 Kg/m2 medications Malnutrition Being an elderly adult Smoking Cancer a weak immune system diabetes |
2 years post procedure | |
Primary | 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 :
Clean; these are uninfected operative wounds in which no inflammation. Clean/contaminated; These are operative wounds in which the respiratory, alimentary, genital, or urinary tract is entered Under controlled conditions and without unusual contamination. Contaminated; These include open, fresh, accidental wounds, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract, and incisions in which acute, non-purulent inflammation is encountered. Dirty ; These include old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera. |
up to 30 days post procedure | |
Secondary | 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 | |
Secondary | 30-day Return to Operating Room (ROR) | 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 | |
Secondary | 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 |
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