Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy

NCT04496180 | Unknown FDA Device

• 1 other identifier: UNGeneva
• Study Type: interventional
• Target: 334
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surgical Site Infection; Length of Stay; Seroma; Hematoma

Keywords

pNPWT; PREVENA; SSI; morbidity; dehiscence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Length of stay (LOS) in days.

  30 days post procedure

• 30-day Return to Operating Room (ROR)

  30 days post procedure

• Incidence rates of wound complications

  30 days post procedure

Other Outcomes (1)

• A rate of parietal incisional hernia apparition after surgery

  2 years post procedure

Study Arms (2)

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.

Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies

Simple dressing

ACTIVE COMPARATOR

Simple dressing; standard, waterproof dressing applied to wound

Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies

Interventions

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.

Also known as: PREVENA

PREVENA (CiPNT); Simple dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.: collaborator
• Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.: collaborator
• Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.: collaborator
• Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.: collaborator
• Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.: collaborator

Related Publications (19)

• 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.

  PMID: 22868327 RESULT

• 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.

  PMID: 26026135 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.

  PMID: 24754343 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.

  PMID: 24106562 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.

  PMID: 21868417 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.

  PMID: 23231938 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.

  PMID: 27416813 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.

  PMID: 28717587 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.

  PMID: 19911098 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.

  PMID: 21804414 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.

  PMID: 25125244 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.

  PMID: 28705547 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.

  PMID: 23539123 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.

  PMID: 26313829 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.

  PMID: 27844201 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.

  PMID: 24201395 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.

  PMID: 30912582 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.

  PMID: 31592899 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.

  PMID: 25554246 RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Seroma; Hematoma

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Hemorrhage

Central Study Contacts

Ziad Abbassi, M.D.

CONTACT

0041766931667; Ziad.abbassi@hcuge.ch

Jérémy Meyer, Ph.D.

CONTACT

0041763161984; Jeremy.meyer@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.D.

Model Details: * Study Type: Interventional (Clinical Trial) * 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

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: August 3, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2025
• Last Updated: April 30, 2021

Record last verified: 2021-04