Surgical Site InfectionCiPNT/SSINCT04496180
Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
A study testing Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies in people with Surgical Site Infection and Length of Stay, run by University Hospital, Geneva.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Length of Stay, Seroma
- What is being tested?
- Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
Read the detailed description
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.
- Conditions
- Surgical Site Infection, Length of Stay, Seroma, Hematoma
- Being tested
- Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies
- Keywords
- pNPWT, PREVENA, SSI, morbidity, dehiscence
- Medical subject headings
- Surgical Wound Infection, Seroma, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomiesDevice
Also called PREVENA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days post procedure
Secondary outcomes (3)
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.
Measured: 30 days post procedure
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.
Measured: 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.
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * 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
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbassi Ziad, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496180
- Sponsor's protocol ID
- UNGeneva
- Acronym
- CiPNT/SSI
- Status last verified
- Apr 2021
- First submitted
- 16 Jul 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 22868327Gorgulu 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.
PubMed 26026135Dohmen 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.
PubMed 24754343Ingargiola 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.
PubMed 24106562Wilkes 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.
PubMed 21868417Vargo 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.
PubMed 23231938Zaidi 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.
PubMed 27416813Gunatilake 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.
PubMed 28717587Reddix 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.
PubMed 19911098Stannard 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.
PubMed 21804414Pauser 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.
PubMed 25125244Redfern 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.
PubMed 28705547Hansen 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.
PubMed 23539123Semsarzadeh 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.
PubMed 26313829Wiegering 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.
PubMed 27844201
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Wound Dressing Versus Prophylactic Negative-pressure Wound Therapy After Emergency Laparotomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04496180
- Acronym / sponsor ID
- CiPNT/SSI / UNGeneva
- Conditions
- Surgical Site Infection, Length of Stay, Seroma, Hematoma
- Keywords
- pNPWT, PREVENA, SSI, morbidity, dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * 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
| Arm | Type | Receives |
|---|---|---|
| PREVENA (CiPNT) | Experimental | Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomiesTarget 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 | Device: Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomiesSimple dressing; standard, waterproof dressing applied to wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomiesAlso: PREVENATarget 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. | Device | PREVENA (CiPNT), Simple dressing |
Primary outcome
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
Time frame: up to 30 days post procedure
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.
3 secondary outcomes
Length of stay (LOS) in days.
Time frame: 30 days post procedure
30-day Return to Operating Room (ROR)
Time frame: 30 days post procedure
Incidence rates of wound complications
Time frame: 30 days post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Results publication: PubMed 22868327Conde-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.
- Results publication: PubMed 26026135Gorgulu 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.
- Results publication: PubMed 24754343Dohmen 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.
- Results publication: PubMed 24106562Ingargiola 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.
- Results publication: PubMed 21868417Wilkes 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.
- Results publication: PubMed 23231938Vargo 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.
- Results publication: PubMed 27416813Zaidi 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.
- Results publication: PubMed 28717587Gunatilake 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.
- Results publication: PubMed 19911098Reddix 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.
- Results publication: PubMed 21804414Stannard 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.
- Results publication: PubMed 25125244Pauser 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.
- Results publication: PubMed 28705547Redfern 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies in people with Surgical Site Infection and Length of Stay, run by University Hospital, Geneva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziad Abbassi, M.D. (0041766931667, Ziad.abbassi@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: up to 30 days post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496180, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.