Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
NCT ID: NCT04496180
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
334 participants
INTERVENTIONAL
2021-09-01
2025-09-01
Brief Summary
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Secondly the investigators aim to study the economic impact of CINPt used after abdominal emergency laparotomies.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Estimated Enrollment: 334
* Allocation: Randomized control trial
* Intervention Model: Parallel Assignment
* Intervention Model Description: 2 separate treatment arms
* Primary Purpose: Prevention
* Official Title: Standard wound dressing versus prophylactic negative-pressure wound therapy after emergency laparotomy
* Estimated Study Start Date: 09.2020
* Estimated Primary Completion Date:09.2021
* Estimated Study Completion Date: 09.2025
PREVENTION
NONE
Study Groups
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PREVENA (CiPNT)
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.
Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies
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.
Simple dressing
Simple dressing; standard, waterproof dressing applied to wound
Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies
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.
Interventions
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Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥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
* 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.
18 Years
ALL
No
Sponsors
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Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.
UNKNOWN
Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.
UNKNOWN
Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.
UNKNOWN
Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.
UNKNOWN
Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.
UNKNOWN
University Hospital, Geneva
OTHER
Responsible Party
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Abbassi Ziad
Principal investigator, M.D.
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UNGeneva
Identifier Type: -
Identifier Source: org_study_id
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