Postoperative Surgical Site InfectionNCT03395613
Negative Pressure Incision Management System in Infrainguinal Vascular Surgery
A study testing NPWT in people with Postoperative Surgical Site Infection, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with encouraging results and is now an accepted element in the arsenal of tools for treating these complications. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Postoperative Surgical Site Infection
- What is being tested?
- NPWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSweden
- Study dates
- 22 Jan 2018to Mar 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years.
- The clinical criterion for study entry is elective:
- Open infrainguinal vascular surgery for peripheral arterial disease
- Thrombendarterectomy (TEA) ii. Bypass surgery with vein or synthetic graft
- Patients on whom complete seal of NPWT can be maintained during the first 24 hours after operation.
- -
Who cannot join
- All emergency cases.
- Infrainguinal endovascular procedures.
- Pre-existing groin infections.
- Sensitivity/allergy to materials used in NPWT dressing.
- Patients on whom an adequate and complete seal of NPWT dressing cannot be obtained.
- Unwillingness to participate. -
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska university Hospital
Stockholm, 17176
Alireza Daryapeyma, MD PhD, +46851700000 ext. 74104, alireza.daryapeyma@sll.se
Rebecka Hultgren, MD PhD, +46851700000 ext. 76596, rebecka.hultgren@sll.se
About this study
Official title: Prophylactic Use of a Negative Pressure Incision Management System in Infrainguinal Vascular Surgery - A Multicentre Randomized Controlled Trial
Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with encouraging results and is now an accepted element in the arsenal of tools for treating these complications. The concept of applying NPWT to closed surgical wounds as a preventive measure is relatively new but draws on the inherent properties of the method which could theoretically lead to reduced seroma formation, wound dehiscence, increased capillary circulation and consequently better wound healing and fewer SSI.
Given the incidence and the consequences of SSI in infrainguinal vascular procedures any appreciable decrease in the burden of these complications could have profound benefits for patients and healthcare facilities. As to date, there are no published data from randomized controlled trials investigating the effectiveness of this prophylactic measure.
The aim of this study is to assess the effect of NPWT applied to closed surgical wounds directly after skin closure compared to standard sterile gauze dressing in reducing the incidence and severity of postoperative SSI in infrainguinal surgical wounds in patients undergoing elective, open vascular surgery.
Read the detailed description
Intervention and Surveillance:
The groin incisions in the intervention group will have NPWT dressing, applied under sterile conditions in the operating room. The NPWT will remain on the patient until postoperative day 7 or earlier if the vacuum seal is broken for any reason. If the NPWT is removed earlier than 7 days, a sterile gauze dressing will be applied to the incision.
The control group will receive a sterile gauze dressing, applied under sterile conditions in the operating room. The dressing van if needed be changed under sterile conditions at the ward on the second postoperative day. The dressing will remain on the patients until postoperative day 7. The dressing may be changed (by a research nurse or the attending surgeon), under sterile conditions if needed during the 8-day period.
After the initial 8-day period, patients in both groups will be supplied with sterile gauze dressings for an additional 6 days during which dressing changes may be carried out under sterile conditions.
All groin incisions will be examined, evaluated and categorized by a qualified research nurse or the attending surgeon, who will be blinded to the initial treatment modality, on the seventh postoperative day, 30 days postoperative and again after three months. Wound cultures will be taken (when possible) if the ASEPSIS score at any one of the three examinations is equal to, or exceeds 21 points.
Preoperative preparations will be the same for both groups. All patients will receive three doses (one pre- and two postoperative) of antibiotic prophylaxis on the day of the operation. Groin incisions will be closed with subcutaneous and intracutaneous monofilament absorbable sutures.
All patients will be asked to respond to the 36-Item Short Form Health Survey (SF-36) and the European Quality of life - Five dimensions (EQ-5D) questionnaires at the time of inclusion and at the one month follow up visit. The Wound QoL (Swedish) questionnaire will be presented to the patients at the one-week follow up.
Primary Endpoint:
- Postoperative SSI within 30 day, classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and in-patient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
Secondary Endpoints:
Postoperative SSI within 90 days, classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and in-patient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
- Antibiotic prescriptions for skin and soft tissue infections within 90 days postoperatively.
- Postoperative SSI within 90 days requiring surgical revision.
- Adverse events directly related the NPWT dressing leading discontinuation of treatment.
- Major lower limb amputation and/or mortality within 90 days postoperatively.
- Changes in reported functionality and quality of life during the 30 day postoperative period.
- Assessment of healthcare related costs within 30 days postoperatively.
Based on previous studies the incidence of postoperative groin SSI is 30-35%. Recent studies using NPWT have shown a reduction in incidence of 50% or more.
Using a sample size calculator (Sealed Envelope Ltd., Clerkenwell Workshops, London EC1R 0AT, UK) for binary outcome superiority trials with an alpha level of 0.05 for 80% power and an estimated incidence reduction from 30% to 10% using NPWT a sample size of 59 patients in each arm and a total sample size of 118 is required.
Randomization will occur once the skin incision has been closed. In cases of bilateral groin incision the right groin will be randomized and the left allocated the other arm of the trial. The surgeons, the operating room personnel and the investigators evaluating the outcome will not be blinded to the intervention.
Missing data will be treated based on the type data missing. In cases where missing data will affect the primary outcome the cases wil be deleted but accounted for in the final report.
Statistical Analysis Plan:
The data from each patient will be analysed using appropriate statistical methods for categorical and continuous and comparative analysis in respect to risk factors and outcome, both primary and secondary as previously defined. Absolute risk increase or reduction, as well as numbers needed to treat for NPWT use will be reported.
Analysis of primary outcomes will be done based on the intention to treat principle. Student's t-test and Pearson's chi-square or Fisher's exact test for continuous and categorical data, respectively. In cases where bilateral incisions are planned, the right groin will be randomized and the left will receive the alternate treatment. For subjects lost to follow up, the last recorded follow up/outcome will be recorded as their final outcome.
Analysis of secondary outcome data will be done according to normal distribution of data whrereby non-normally distributed data will be analysed using the Mann-Whitney U-test.
All tests will be 2-sided and P ≤ 0.05 will be considered statistically signinficant for all tests.
The statistical analyses will be done using SPSS version 23 (IBM, Armonk, NY, USA).
All patients will be asked to respond to the 36-Item Short Form Health Survey (SF-36) and European Quality of life - Five dimensions (EQ-5D) and Wound QoL questionnaires at the time of inclusion and at the one month follow up visit.
The data from these questionnaires will be stratified and analysed using appropriate statistical methods.
Ethical considerations:
General regulations The study will be performed in accordance with the declaration of Helsinki as revised at the 64th WMA General Assembly in Fortaleza, Brazil, October 2013. Approval of the study protocol has been obtained from the Regional Ethics Committee.
Informed consent Prior to enrolment all patients will receive written and oral information about the study. The patients will only be included after obtaining written and informed consent.
- Conditions
- Postoperative Surgical Site Infection
- Being tested
- NPWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWTDevice
Also called Prevena
Negative pressure wound thearpy on closed surgical wounds
| Study group | Role | What they receive |
|---|---|---|
| Standard management | No intervention | Standard sterile gauze dressing on surgical groin wound. |
| NPWT management | Experimental | Negative Pressure Wound Therapy dressing on surgical groin wound. Receives: Device: NPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative surgical site infection (SSI) within 30 days.
SSI classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
Measured: 30 days
Secondary outcomes (8)
Postoperative SSI within 90 days
SSI classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythmea, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
Measured: 90 days
Antibiotic prescriptions for skin and soft tissue infections within 90 days postoperatively.
Measured: 90 days
Postoperative SSI within 90 days requiring surgical revision.
Measured: 90 days
Adverse events directly related the NPWT dressing leading discontinuation of treatment.
Death due to procedural complications
- Vascular complications
- Severe or life-threatening bleeding
- Limb loss
- TIA/stroke or myocardial infarction
- Allergic skin reactions
- Device related skin damage e.g. abrasions, blisters or wounds
Measured: 7 dats
Major lower limb amputation and/or mortality within 90 days postoperatively.
Measured: 90 days
Changes in reported quality of life during the 30 day postoperative period.
Changes in QoL assessment questionnaires (SF-36 and EQ-5D) preoperatively and 30 days postoperative.
Measured: 30 days
Assessment of healthcare related costs within 30 days postoperatively.
Measured: 30 days
Assessment of quality of life during the first seven day period after operation
The Wound QoL questionnaire will help assess QoL during the period that the NPWT device (Prevena) will be used in patients randomized to the experimental group.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start22 Jan 2018
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (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 Postoperative Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Preoperative randomization
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Alireza Daryapeyma, MD PhD, Karolinska University Hospital
- Investigators
- Alireza Daryapeyma, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395613
- Sponsor's protocol ID
- ADaryapeyma
- Status last verified
- Mar 2022
- First submitted
- 27 Dec 2017
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Vriesendorp TM, Morelis QJ, Devries JH, Legemate DA, Hoekstra JB. Early post-operative glucose levels are an independent risk factor for infection after peripheral vascular surgery. A retrospective study. Eur J Vasc Endovasc Surg. 2004 Nov;28(5):520-5. doi: 10.1016/j.ejvs.2004.08.006.
PubMed 15465374Cater JE, van der Linden J. Simulation of carbon dioxide insufflation via a diffuser in an open surgical wound model. Med Eng Phys. 2015 Jan;37(1):121-5. doi: 10.1016/j.medengphy.2014.07.011. Epub 2014 Aug 5.
PubMed 25103346Turtiainen J, Saimanen EI, Makinen KT, Nykanen AI, Venermo MA, Uurto IT, Hakala T. Effect of triclosan-coated sutures on the incidence of surgical wound infection after lower limb revascularization surgery: a randomized controlled trial. World J Surg. 2012 Oct;36(10):2528-34. doi: 10.1007/s00268-012-1655-4.
PubMed 22618956Vogel TR, Dombrovskiy VY, Carson JL, Haser PB, Lowry SF, Graham AM. Infectious complications after elective vascular surgical procedures. J Vasc Surg. 2010 Jan;51(1):122-9; discussion 129-30. doi: 10.1016/j.jvs.2009.08.006. Epub 2009 Dec 2.
PubMed 19954920Kent KC, Bartek S, Kuntz KM, Anninos E, Skillman JJ. Prospective study of wound complications in continuous infrainguinal incisions after lower limb arterial reconstruction: incidence, risk factors, and cost. Surgery. 1996 Apr;119(4):378-83. doi: 10.1016/s0039-6060(96)80135-8.
PubMed 8644000de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
PubMed 19398246Kuy S, Dua A, Desai S, Dua A, Patel B, Tondravi N, Seabrook GR, Brown KR, Lewis BD, Lee CJ, Kuy S, Subbarayan R, Rossi PJ. Surgical site infections after lower extremity revascularization procedures involving groin incisions. Ann Vasc Surg. 2014 Jan;28(1):53-8. doi: 10.1016/j.avsg.2013.08.002. Epub 2013 Nov 1.
PubMed 24189008Krizek TJ, Robson MC. Evolution of quantitative bacteriology in wound management. Am J Surg. 1975 Nov;130(5):579-84. doi: 10.1016/0002-9610(75)90516-4. No abstract available.
PubMed 1106243Arbeit RD, Dunn RM. Expression of capsular polysaccharide during experimental focal infection with Staphylococcus aureus. J Infect Dis. 1987 Dec;156(6):947-52. doi: 10.1093/infdis/156.6.947.
PubMed 3680994Garibaldi RA, Cushing D, Lerer T. Risk factors for postoperative infection. Am J Med. 1991 Sep 16;91(3B):158S-163S. doi: 10.1016/0002-9343(91)90362-2.
PubMed 1928157Chang JK, Calligaro KD, Ryan S, Runyan D, Dougherty MJ, Stern JJ. Risk factors associated with infection of lower extremity revascularization: analysis of 365 procedures performed at a teaching hospital. Ann Vasc Surg. 2003 Jan;17(1):91-6. doi: 10.1007/s10016-001-0337-8. Epub 2003 Jan 15.
PubMed 12522701Anderson DJ. Surgical site infections. Infect Dis Clin North Am. 2011 Mar;25(1):135-53. doi: 10.1016/j.idc.2010.11.004.
PubMed 21315998Lee ES, Santilli SM, Olson MM, Kuskowski MA, Lee JT. Wound infection after infrainguinal bypass operations: multivariate analysis of putative risk factors. Surg Infect (Larchmt). 2000 Winter;1(4):257-63. doi: 10.1089/109629600750067183.
PubMed 12594881Dosluoglu HH, Loghmanee C, Lall P, Cherr GS, Harris LM, Dryjski ML. Management of early (<30 day) vascular groin infections using vacuum-assisted closure alone without muscle flap coverage in a consecutive patient series. J Vasc Surg. 2010 May;51(5):1160-6. doi: 10.1016/j.jvs.2009.11.053. Epub 2010 Mar 31.
PubMed 20356703Weed T, Ratliff C, Drake DB. Quantifying bacterial bioburden during negative pressure wound therapy: does the wound VAC enhance bacterial clearance? Ann Plast Surg. 2004 Mar;52(3):276-9; discussion 279-80. doi: 10.1097/01.sap.0000111861.75927.4d.
PubMed 15156981
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Use of a Negative Pressure Incision Management System in Infrainguinal Vascular Surgery - A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03395613
- Acronym / sponsor ID
- ADaryapeyma
- Conditions
- Postoperative Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Jan 2018 (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.
Negative pressure wound therapy (NPWT) has been used in treating postoperative SSI with encouraging results and is now an accepted element in the arsenal of tools for treating these complications. The concept of applying NPWT to closed surgical wounds as a preventive measure is relatively new but draws on the inherent properties of the method which could theoretically lead to reduced seroma formation, wound dehiscence, increased capillary circulation and consequently better wound healing and fewer SSI.
Given the incidence and the consequences of SSI in infrainguinal vascular procedures any appreciable decrease in the burden of these complications could have profound benefits for patients and healthcare facilities. As to date, there are no published data from randomized controlled trials investigating the effectiveness of this prophylactic measure.
The aim of this study is to assess the effect of NPWT applied to closed surgical wounds directly after skin closure compared to standard sterile gauze dressing in reducing the incidence and severity of postoperative SSI in infrainguinal surgical wounds in patients undergoing elective, open vascular surgery.
Detailed description
Intervention and Surveillance:
The groin incisions in the intervention group will have NPWT dressing, applied under sterile conditions in the operating room. The NPWT will remain on the patient until postoperative day 7 or earlier if the vacuum seal is broken for any reason. If the NPWT is removed earlier than 7 days, a sterile gauze dressing will be applied to the incision.
The control group will receive a sterile gauze dressing, applied under sterile conditions in the operating room. The dressing van if needed be changed under sterile conditions at the ward on the second postoperative day. The dressing will remain on the patients until postoperative day 7. The dressing may be changed (by a research nurse or the attending surgeon), under sterile conditions if needed during the 8-day period.
After the initial 8-day period, patients in both groups will be supplied with sterile gauze dressings for an additional 6 days during which dressing changes may be carried out under sterile conditions.
All groin incisions will be examined, evaluated and categorized by a qualified research nurse or the attending surgeon, who will be blinded to the initial treatment modality, on the seventh postoperative day, 30 days postoperative and again after three months. Wound cultures will be taken (when possible) if the ASEPSIS score at any one of the three examinations is equal to, or exceeds 21 points.
Preoperative preparations will be the same for both groups. All patients will receive three doses (one pre- and two postoperative) of antibiotic prophylaxis on the day of the operation. Groin incisions will be closed with subcutaneous and intracutaneous monofilament absorbable sutures.
All patients will be asked to respond to the 36-Item Short Form Health Survey (SF-36) and the European Quality of life - Five dimensions (EQ-5D) questionnaires at the time of inclusion and at the one month follow up visit. The Wound QoL (Swedish) questionnaire will be presented to the patients at the one-week follow up.
Primary Endpoint:
- Postoperative SSI within 30 day, classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and in-patient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
Secondary Endpoints:
Postoperative SSI within 90 days, classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and in-patient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
- Antibiotic prescriptions for skin and soft tissue infections within 90 days postoperatively.
- Postoperative SSI within 90 days requiring surgical revision.
- Adverse events directly related the NPWT dressing leading discontinuation of treatment.
- Major lower limb amputation and/or mortality within 90 days postoperatively.
- Changes in reported functionality and quality of life during the 30 day postoperative period.
- Assessment of healthcare related costs within 30 days postoperatively.
Based on previous studies the incidence of postoperative groin SSI is 30-35%. Recent studies using NPWT have shown a reduction in incidence of 50% or more.
Using a sample size calculator (Sealed Envelope Ltd., Clerkenwell Workshops, London EC1R 0AT, UK) for binary outcome superiority trials with an alpha level of 0.05 for 80% power and an estimated incidence reduction from 30% to 10% using NPWT a sample size of 59 patients in each arm and a total sample size of 118 is required.
Randomization will occur once the skin incision has been closed. In cases of bilateral groin incision the right groin will be randomized and the left allocated the other arm of the trial. The surgeons, the operating room personnel and the investigators evaluating the outcome will not be blinded to the intervention.
Missing data will be treated based on the type data missing. In cases where missing data will affect the primary outcome the cases wil be deleted but accounted for in the final report.
Statistical Analysis Plan:
The data from each patient will be analysed using appropriate statistical methods for categorical and continuous and comparative analysis in respect to risk factors and outcome, both primary and secondary as previously defined. Absolute risk increase or reduction, as well as numbers needed to treat for NPWT use will be reported.
Analysis of primary outcomes will be done based on the intention to treat principle. Student's t-test and Pearson's chi-square or Fisher's exact test for continuous and categorical data, respectively. In cases where bilateral incisions are planned, the right groin will be randomized and the left will receive the alternate treatment. For subjects lost to follow up, the last recorded follow up/outcome will be recorded as their final outcome.
Analysis of secondary outcome data will be done according to normal distribution of data whrereby non-normally distributed data will be analysed using the Mann-Whitney U-test.
All tests will be 2-sided and P ≤ 0.05 will be considered statistically signinficant for all tests.
The statistical analyses will be done using SPSS version 23 (IBM, Armonk, NY, USA).
All patients will be asked to respond to the 36-Item Short Form Health Survey (SF-36) and European Quality of life - Five dimensions (EQ-5D) and Wound QoL questionnaires at the time of inclusion and at the one month follow up visit.
The data from these questionnaires will be stratified and analysed using appropriate statistical methods.
Ethical considerations:
General regulations The study will be performed in accordance with the declaration of Helsinki as revised at the 64th WMA General Assembly in Fortaleza, Brazil, October 2013. Approval of the study protocol has been obtained from the Regional Ethics Committee.
Informed consent Prior to enrolment all patients will receive written and oral information about the study. The patients will only be included after obtaining written and informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preoperative randomization
| Arm | Type | Receives |
|---|---|---|
| Standard management | No intervention | –Standard sterile gauze dressing on surgical groin wound. |
| NPWT management | Experimental | Device: NPWTNegative Pressure Wound Therapy dressing on surgical groin wound. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 18 years.
- The clinical criterion for study entry is elective:
- Patients on whom complete seal of NPWT can be maintained during the first 24 hours after operation.
- -
Key exclusion criteria (6 listed)
- All emergency cases.
- Infrainguinal endovascular procedures.
- Pre-existing groin infections.
- Sensitivity/allergy to materials used in NPWT dressing.
- Patients on whom an adequate and complete seal of NPWT dressing cannot be obtained.
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 |
|---|---|---|
| NPWTAlso: PrevenaNegative pressure wound thearpy on closed surgical wounds | Device | NPWT management |
Primary outcome
Postoperative surgical site infection (SSI) within 30 days.
Time frame: 30 days
SSI classified according to the scoring method ASEPSIS (Additional treatment,Serous discharge, Erythema, Purulent exudates, Separation of the deep tissues, Isolation of bacteria and inpatient Stay) and graded using the Samson classification (Grade I-V), confirmed by positive identification of the infectious agent.
8 secondary outcomes
Postoperative SSI within 90 days
Time frame: 90 days
Antibiotic prescriptions for skin and soft tissue infections within 90 days postoperatively.
Time frame: 90 days
Postoperative SSI within 90 days requiring surgical revision.
Time frame: 90 days
Adverse events directly related the NPWT dressing leading discontinuation of treatment.
Time frame: 7 dats
Major lower limb amputation and/or mortality within 90 days postoperatively.
Time frame: 90 days
Changes in reported quality of life during the 30 day postoperative period.
Time frame: 30 days
Assessment of healthcare related costs within 30 days postoperatively.
Time frame: 30 days
Assessment of quality of life during the first seven day period after operation
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 15465374Vriesendorp TM, Morelis QJ, Devries JH, Legemate DA, Hoekstra JB. Early post-operative glucose levels are an independent risk factor for infection after peripheral vascular surgery. A retrospective study. Eur J Vasc Endovasc Surg. 2004 Nov;28(5):520-5. doi: 10.1016/j.ejvs.2004.08.006.
- Background: PubMed 25103346Cater JE, van der Linden J. Simulation of carbon dioxide insufflation via a diffuser in an open surgical wound model. Med Eng Phys. 2015 Jan;37(1):121-5. doi: 10.1016/j.medengphy.2014.07.011. Epub 2014 Aug 5.
- Background: PubMed 22618956Turtiainen J, Saimanen EI, Makinen KT, Nykanen AI, Venermo MA, Uurto IT, Hakala T. Effect of triclosan-coated sutures on the incidence of surgical wound infection after lower limb revascularization surgery: a randomized controlled trial. World J Surg. 2012 Oct;36(10):2528-34. doi: 10.1007/s00268-012-1655-4.
- Results publication: PubMed 19954920Vogel TR, Dombrovskiy VY, Carson JL, Haser PB, Lowry SF, Graham AM. Infectious complications after elective vascular surgical procedures. J Vasc Surg. 2010 Jan;51(1):122-9; discussion 129-30. doi: 10.1016/j.jvs.2009.08.006. Epub 2009 Dec 2.
- Results publication: PubMed 8644000Kent KC, Bartek S, Kuntz KM, Anninos E, Skillman JJ. Prospective study of wound complications in continuous infrainguinal incisions after lower limb arterial reconstruction: incidence, risk factors, and cost. Surgery. 1996 Apr;119(4):378-83. doi: 10.1016/s0039-6060(96)80135-8.
- Results publication: PubMed 19398246de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23.
- Results publication: PubMed 24189008Kuy S, Dua A, Desai S, Dua A, Patel B, Tondravi N, Seabrook GR, Brown KR, Lewis BD, Lee CJ, Kuy S, Subbarayan R, Rossi PJ. Surgical site infections after lower extremity revascularization procedures involving groin incisions. Ann Vasc Surg. 2014 Jan;28(1):53-8. doi: 10.1016/j.avsg.2013.08.002. Epub 2013 Nov 1.
- Results publication: PubMed 1106243Krizek TJ, Robson MC. Evolution of quantitative bacteriology in wound management. Am J Surg. 1975 Nov;130(5):579-84. doi: 10.1016/0002-9610(75)90516-4. No abstract available.
- Results publication: PubMed 3680994Arbeit RD, Dunn RM. Expression of capsular polysaccharide during experimental focal infection with Staphylococcus aureus. J Infect Dis. 1987 Dec;156(6):947-52. doi: 10.1093/infdis/156.6.947.
- Results publication: PubMed 1928157Garibaldi RA, Cushing D, Lerer T. Risk factors for postoperative infection. Am J Med. 1991 Sep 16;91(3B):158S-163S. doi: 10.1016/0002-9343(91)90362-2.
- Results publication: PubMed 12522701Chang JK, Calligaro KD, Ryan S, Runyan D, Dougherty MJ, Stern JJ. Risk factors associated with infection of lower extremity revascularization: analysis of 365 procedures performed at a teaching hospital. Ann Vasc Surg. 2003 Jan;17(1):91-6. doi: 10.1007/s10016-001-0337-8. Epub 2003 Jan 15.
- Results publication: PubMed 21315998Anderson DJ. Surgical site infections. Infect Dis Clin North Am. 2011 Mar;25(1):135-53. doi: 10.1016/j.idc.2010.11.004.
- Individual participant dataSharing planned: No
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Surgical Wound Infection, Neck Infection
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.
Alireza Daryapeyma, MD PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPWT in people with Postoperative Surgical Site Infection, run by Karolinska University Hospital at 1 site in Sweden.
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 6 inclusion and 6 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative surgical site infection (SSI) within 30 days. (time frame: 30 days). 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 NCT03395613, 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 7 Apr 2022.