Surgical Wound InfectionNCT02348034
A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)
A study testing Prevena Dressing in people with Surgical Wound Infection, run by University of Saskatchewan at 3 sites in Canada.
Trial summary
The study will explore the ability of negative pressure wound therapy (Prevena dressing) to reduce post operative superficial surgical site infection rate in elective colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Prevena Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2015to 7 Dec 2020
- 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
- Age equal or greater than 18 years
- Patient undergoing colorectal resective surgery for any reason (benign or malignant) such as diverticular disease, colorectal cancer or inflammatory bowel disease through a laparotomy wound
- Class II surgical wound
- Laparoscopically assisted colorectal procedure
Who cannot join
- Patient requires emergent or urgent operation
- Patient has advanced colorectal malignancy associated with peritoneal carcinomatosis
- Class III or IV surgical wound
- Laparoscopic surgery involving intracorporeal colorectal resection and anastomosis
- Patient has a previous disfigured midline laparotomy surgical scar requiring wide excision of skin, subcutaneous tissue, fascia and muscle
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
St. Paul's Hospital, 1081 Burrard Street, C310
Vancouver, British Columbia, V6Z 1Y6
About this study
The study will explore the ability of negative pressure wound therapy (Prevena dressing) to reduce post operative superficial surgical site infection rate in elective colorectal surgery. Half of the participants will receive Prevena dressing on closed incision immediately after the operation while other half will receive conventional surgical dressing.
Read the detailed description
The trial will commence with recruitment of participants after an assessment of their potential eligibility. Those recruited in the trial will sign informed consent either on the day of surgery or during the PAC appointment, before any study-related activities are performed.
Perioperative measures will include bowel preparation with Fleet Phospho-soda, preoperative shaving with electric clippers 1 hour before the operation, and intravenous prophylactic antibiotic administered 30 minutes before the incision, and repeated in OR if the operation lasts more than 3 hours, and discontinued within 24 h after the operation. In all procedures, chlorhexidine solution will be applied to the skin to achieve preoperative skin antisepsis, and the usual reusable or disposable surgical gowns, drapes, and gloving will be used. The type of surgical procedure will be a colorectal resection for any malignant or benign condition of the colon, rectum or anal canal via a laparotomy wound. The type of incision will either be a vertical midline or transverse abdominal incision. Laparotomy wound will be closed primarily as a mass closure technique utilizing polydioxanone (PDS) or Nylon suture. Skin and subcutaneous tissues will be approximated using stainless-steel staples.
During the surgery, assessment of eligibility (including wound classification) will be completed, and if eligible, the participant will be randomized to one of the two treatment arms - group A (conventional dressing) or group B (Prevena dressing). The randomization scheme is described later in the protocol. After the surgical wound is closed, the assigned dressing - conventional dressing (Mepore) or Prevena dressing - will be applied.
For participants in group A (conventional dressing) the wound will be inspected on an as needed basis during postoperative days 1-6 to assess for SSI (where day 0 = day of surgery). On postoperative day 7, the dressing will be removed. If the participant is in hospital, the wound care nurse or study staff will remove the dressing and examine the wound for SSI. If the participant was discharged before postoperative day 7, the home care nurse or the participant's physician will remove the dressing. The patient will have been sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home care nurse or their physician to complete for the assessment for SSI.
For participants randomized to group B (Prevena dressing), the wound care nurse or study staff will inspect the dressing daily during postoperative days 1-6 (where day 0 = day of surgery) to assess for proper functioning of the Prevena dressing. If the participant is discharged before postoperative day 7, the wound care nurse or study staff will contact the participant daily to check for proper functioning of the Prevena dressing. On postoperative day 7, the Prevena dressing will be removed. If the participant is in hospital, the wound care nurse or study staff (residents or Surgeons) will remove the dressing and assess the wound for SSI. If the participant was discharged before postoperative day 7, the home care nurse or the participant's physician will remove the dressing. The patient will have been sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home care nurse or their physician to complete for signs of SSI.
If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. In case it is not possible for the participant to visit the clinic for assessment of SSI by the study team, the participants will have been sent home with a SSI Confirmation form to be completed by the participant's physician.
The wound care nurse or study staff will conduct post-discharge follow-up on postoperative days 14 (± 2 days) and 21 (± 2 days) by telephoning the family physician or the participant to check whether there are signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. If not possible, the participant will be instructed to ask their physician to complete the SSI Confirmation form.
On postoperative day 30 (± 7 days), the participant will be seen in the clinic by the treating surgeon as a part of the treatment and follow-up plan, and the wound will be assessed for SSI. For participants who are not able to come to the clinic, the study team will contact the participant or the family physician by telephone to check whether there are signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. If not possible, the participant will be instructed to ask their physician to complete the SSI Confirmation form.
As described above, each participant will have up to 12 study visits (11 scheduled visits, including the day of surgery, plus one clinic visit if there is suspicion of SSI). At any point, however, once SSI is confirmed, the participant will undergo no further study visits.
- Conditions
- Surgical Wound Infection
- Being tested
- Prevena Dressing
- Keywords
- Surgical Site Infection (SSI), Negative Pressure Wound Therapy (NPWT)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena DressingDevice
Prevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections.
| Study group | Role | What they receive |
|---|---|---|
| Prevena Dressing | Experimental | This group will receive prevena dressing after the elective colorectal surgery Receives: Device: Prevena Dressing |
| Conventional dressing | No intervention | This group will receive conventional dressing after the elective colorectal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/Absence of superficial surgical site infection
Primary outcome of interest will be the presence and/or absence of superficial surgical site infection at postoperative day 30.
Measured: Postoperative day 30.
Secondary outcomes (1)
Presence/Absence of intervention related side effects
The secondary outcome will be any side effects related to the intervention.
Measured: Postoperative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startNov 2015
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc., Saskatoon Health Region
- Responsible party
- Principal investigator, Gary Groot, University of Saskatchewan
- Investigators
- Gary Groot, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348034
- Sponsor's protocol ID
- 14-259
- Status last verified
- Apr 2021
- First submitted
- 22 Jan 2015
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Measures displayed on Hospital Compare. 2013. Available at: http://www.medicare.gov/hospitalcompare/ Data/Measures-Displayed.html. Accessed March 22, 2013
Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a "high outlier" institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009 Mar;52(3):374-9. doi: 10.1007/DCR.0b013e31819a5e45.
PubMed 19333034Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
PubMed 21079110Tang R, Chen HH, Wang YL, Changchien CR, Chen JS, Hsu KC, Chiang JM, Wang JY. Risk factors for surgical site infection after elective resection of the colon and rectum: a single-center prospective study of 2,809 consecutive patients. Ann Surg. 2001 Aug;234(2):181-9. doi: 10.1097/00000658-200108000-00007.
PubMed 11505063Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. doi: 10.1097/01.sla.0000124292.21605.99.
PubMed 15082963Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.
PubMed 10896795Weiss CA 3rd, Statz CL, Dahms RA, Remucal MJ, Dunn DL, Beilman GJ. Six years of surgical wound infection surveillance at a tertiary care center: review of the microbiologic and epidemiological aspects of 20,007 wounds. Arch Surg. 1999 Oct;134(10):1041-8. doi: 10.1001/archsurg.134.10.1041.
PubMed 10522843Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
PubMed 10219875Martone WJ, Nichols RL. Recognition, prevention, surveillance, and management of surgical site infections: introduction to the problem and symposium overview. Clin Infect Dis. 2001 Sep 1;33 Suppl 2:S67-8. doi: 10.1086/321859. No abstract available.
PubMed 11486301Gaynes RP, Culver DH, Horan TC, Edwards JR, Richards C, Tolson JS. Surgical site infection (SSI) rates in the United States, 1992-1998: the National Nosocomial Infections Surveillance System basic SSI risk index. Clin Infect Dis. 2001 Sep 1;33 Suppl 2:S69-77. doi: 10.1086/321860.
PubMed 11486302Astagneau P, Rioux C, Golliot F, Brucker G; INCISO Network Study Group. Morbidity and mortality associated with surgical site infections: results from the 1997-1999 INCISO surveillance. J Hosp Infect. 2001 Aug;48(4):267-74. doi: 10.1053/jhin.2001.1003.
PubMed 11461127Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
PubMed 10580621de 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 19398246Measures displayed on Hospital Compare. 2013. Available at: ttp://www.medicare.gov/hospitalcompare /Data/Measures-Displayed.html. Accessed March 22, 2013.
Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. doi: 10.1001/jama.2010.841.
PubMed 20571014
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)
- ClinicalTrials.gov ID
- NCT02348034
- Acronym / sponsor ID
- 14-259
- Conditions
- Surgical Wound Infection
- Keywords
- Surgical Site Infection (SSI), Negative Pressure Wound Therapy (NPWT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc., Saskatoon Health Region
- Study start
- Nov 2015 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 28 Jan 2015 (estimated)
- 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.
The study will explore the ability of negative pressure wound therapy (Prevena dressing) to reduce post operative superficial surgical site infection rate in elective colorectal surgery. Half of the participants will receive Prevena dressing on closed incision immediately after the operation while other half will receive conventional surgical dressing.
Detailed description
The trial will commence with recruitment of participants after an assessment of their potential eligibility. Those recruited in the trial will sign informed consent either on the day of surgery or during the PAC appointment, before any study-related activities are performed.
Perioperative measures will include bowel preparation with Fleet Phospho-soda, preoperative shaving with electric clippers 1 hour before the operation, and intravenous prophylactic antibiotic administered 30 minutes before the incision, and repeated in OR if the operation lasts more than 3 hours, and discontinued within 24 h after the operation. In all procedures, chlorhexidine solution will be applied to the skin to achieve preoperative skin antisepsis, and the usual reusable or disposable surgical gowns, drapes, and gloving will be used. The type of surgical procedure will be a colorectal resection for any malignant or benign condition of the colon, rectum or anal canal via a laparotomy wound. The type of incision will either be a vertical midline or transverse abdominal incision. Laparotomy wound will be closed primarily as a mass closure technique utilizing polydioxanone (PDS) or Nylon suture. Skin and subcutaneous tissues will be approximated using stainless-steel staples.
During the surgery, assessment of eligibility (including wound classification) will be completed, and if eligible, the participant will be randomized to one of the two treatment arms - group A (conventional dressing) or group B (Prevena dressing). The randomization scheme is described later in the protocol. After the surgical wound is closed, the assigned dressing - conventional dressing (Mepore) or Prevena dressing - will be applied.
For participants in group A (conventional dressing) the wound will be inspected on an as needed basis during postoperative days 1-6 to assess for SSI (where day 0 = day of surgery). On postoperative day 7, the dressing will be removed. If the participant is in hospital, the wound care nurse or study staff will remove the dressing and examine the wound for SSI. If the participant was discharged before postoperative day 7, the home care nurse or the participant's physician will remove the dressing. The patient will have been sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home care nurse or their physician to complete for the assessment for SSI.
For participants randomized to group B (Prevena dressing), the wound care nurse or study staff will inspect the dressing daily during postoperative days 1-6 (where day 0 = day of surgery) to assess for proper functioning of the Prevena dressing. If the participant is discharged before postoperative day 7, the wound care nurse or study staff will contact the participant daily to check for proper functioning of the Prevena dressing. On postoperative day 7, the Prevena dressing will be removed. If the participant is in hospital, the wound care nurse or study staff (residents or Surgeons) will remove the dressing and assess the wound for SSI. If the participant was discharged before postoperative day 7, the home care nurse or the participant's physician will remove the dressing. The patient will have been sent home with a Post-Op Day 7 follow-up form, and will have been instructed to provide the form to the home care nurse or their physician to complete for signs of SSI.
If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. In case it is not possible for the participant to visit the clinic for assessment of SSI by the study team, the participants will have been sent home with a SSI Confirmation form to be completed by the participant's physician.
The wound care nurse or study staff will conduct post-discharge follow-up on postoperative days 14 (± 2 days) and 21 (± 2 days) by telephoning the family physician or the participant to check whether there are signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. If not possible, the participant will be instructed to ask their physician to complete the SSI Confirmation form.
On postoperative day 30 (± 7 days), the participant will be seen in the clinic by the treating surgeon as a part of the treatment and follow-up plan, and the wound will be assessed for SSI. For participants who are not able to come to the clinic, the study team will contact the participant or the family physician by telephone to check whether there are signs of SSI. If SSI is suspected, the participant will be advised to visit the clinic for assessment of SSI by the study team. If not possible, the participant will be instructed to ask their physician to complete the SSI Confirmation form.
As described above, each participant will have up to 12 study visits (11 scheduled visits, including the day of surgery, plus one clinic visit if there is suspicion of SSI). At any point, however, once SSI is confirmed, the participant will undergo no further study visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena Dressing | Experimental | Device: Prevena DressingThis group will receive prevena dressing after the elective colorectal surgery |
| Conventional dressing | No intervention | –This group will receive conventional dressing after the elective colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age equal or greater than 18 years
- Patient undergoing colorectal resective surgery for any reason (benign or malignant) such as diverticular disease, colorectal cancer or inflammatory bowel disease through a laparotomy wound
- Class II surgical wound
- Laparoscopically assisted colorectal procedure
Key exclusion criteria (5 listed)
- Patient requires emergent or urgent operation
- Patient has advanced colorectal malignancy associated with peritoneal carcinomatosis
- Class III or IV surgical wound
- Laparoscopic surgery involving intracorporeal colorectal resection and anastomosis
- Patient has a previous disfigured midline laparotomy surgical scar requiring wide excision of skin, subcutaneous tissue, fascia and muscle
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 |
|---|---|---|
| Prevena DressingPrevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections. | Device | Prevena Dressing |
Primary outcome
Presence/Absence of superficial surgical site infection
Time frame: Postoperative day 30.
Primary outcome of interest will be the presence and/or absence of superficial surgical site infection at postoperative day 30.
1 secondary outcome
Presence/Absence of intervention related side effects
Time frame: Postoperative day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- BackgroundMeasures displayed on Hospital Compare. 2013. Available at: http://www.medicare.gov/hospitalcompare/ Data/Measures-Displayed.html. Accessed March 22, 2013
- Background: PubMed 19333034Wick EC, Vogel JD, Church JM, Remzi F, Fazio VW. Surgical site infections in a "high outlier" institution: are colorectal surgeons to blame? Dis Colon Rectum. 2009 Mar;52(3):374-9. doi: 10.1007/DCR.0b013e31819a5e45.
- Background: PubMed 21079110Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
- Background: PubMed 11505063Tang R, Chen HH, Wang YL, Changchien CR, Chen JS, Hsu KC, Chiang JM, Wang JY. Risk factors for surgical site infection after elective resection of the colon and rectum: a single-center prospective study of 2,809 consecutive patients. Ann Surg. 2001 Aug;234(2):181-9. doi: 10.1097/00000658-200108000-00007.
- Background: PubMed 15082963Smith RL, Bohl JK, McElearney ST, Friel CM, Barclay MM, Sawyer RG, Foley EF. Wound infection after elective colorectal resection. Ann Surg. 2004 May;239(5):599-605; discussion 605-7. doi: 10.1097/01.sla.0000124292.21605.99.
- Background: PubMed 10896795Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.
- Background: PubMed 10522843Weiss CA 3rd, Statz CL, Dahms RA, Remucal MJ, Dunn DL, Beilman GJ. Six years of surgical wound infection surveillance at a tertiary care center: review of the microbiologic and epidemiological aspects of 20,007 wounds. Arch Surg. 1999 Oct;134(10):1041-8. doi: 10.1001/archsurg.134.10.1041.
- Background: PubMed 10219875Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
- Background: PubMed 11486301Martone WJ, Nichols RL. Recognition, prevention, surveillance, and management of surgical site infections: introduction to the problem and symposium overview. Clin Infect Dis. 2001 Sep 1;33 Suppl 2:S67-8. doi: 10.1086/321859. No abstract available.
- Background: PubMed 11486302Gaynes RP, Culver DH, Horan TC, Edwards JR, Richards C, Tolson JS. Surgical site infection (SSI) rates in the United States, 1992-1998: the National Nosocomial Infections Surveillance System basic SSI risk index. Clin Infect Dis. 2001 Sep 1;33 Suppl 2:S69-77. doi: 10.1086/321860.
- Background: PubMed 11461127Astagneau P, Rioux C, Golliot F, Brucker G; INCISO Network Study Group. Morbidity and mortality associated with surgical site infections: results from the 1997-1999 INCISO surveillance. J Hosp Infect. 2001 Aug;48(4):267-74. doi: 10.1053/jhin.2001.1003.
- Background: PubMed 10580621Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
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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.
Gary Groot principal investigator
University of Saskatchewan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena Dressing in people with Surgical Wound Infection, run by University of Saskatchewan at 3 sites in Canada.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/Absence of superficial surgical site infection (time frame: Postoperative day 30.). 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 NCT02348034, which also lists 35 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 28 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.