A Randomized Controlled Trial Exploring the Ability of Negative Pressure Wound Therapy (NPWT) to Reduce Colorectal Surgical Site Infections (SSI)
NCT ID: NCT02348034
Last Updated: 2021-04-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
126 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-11-30
Study Completion Date
2020-12-07
Brief Summary
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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.
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Detailed Description
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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.
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
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Surgical Wound Infection
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Prevena Dressing
This group will receive prevena dressing after the elective colorectal surgery
Group Type
EXPERIMENTAL
Prevena Dressing
Intervention Type
DEVICE
Prevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections.
Conventional dressing
This group will receive conventional dressing after the elective colorectal surgery
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Prevena Dressing
Prevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Age equal or greater than 18 years
2. 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
3. Class II surgical wound
4. Laparoscopically assisted colorectal procedure
2. 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
3. Class II surgical wound
4. Laparoscopically assisted colorectal procedure
Exclusion Criteria
1. Patient requires emergent or urgent operation
2. Patient has advanced colorectal malignancy associated with peritoneal carcinomatosis
3. Class III or IV surgical wound
4. Laparoscopic surgery involving intracorporeal colorectal resection and anastomosis
5. Patient has a previous disfigured midline laparotomy surgical scar requiring wide excision of skin, subcutaneous tissue, fascia and muscle
2. Patient has advanced colorectal malignancy associated with peritoneal carcinomatosis
3. Class III or IV surgical wound
4. Laparoscopic surgery involving intracorporeal colorectal resection and anastomosis
5. Patient has a previous disfigured midline laparotomy surgical scar requiring wide excision of skin, subcutaneous tissue, fascia and muscle
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Kinetic Concepts, Inc.
INDUSTRY
Sponsor Role
collaborator
Saskatoon Health Region
OTHER
Sponsor Role
collaborator
University of Saskatchewan
OTHER
Sponsor Role
lead
Responsible Party
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Gary Groot
M.D.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Gary Groot
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
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St. Paul's Hospital, 1081 Burrard Street, C310
Vancouver, British Columbia, Canada
Site Status
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
Site Status
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Site Status
Countries
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Canada
References
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Measures displayed on Hospital Compare. 2013. Available at: http://www.medicare.gov/hospitalcompare/ Data/Measures-Displayed.html. Accessed March 22, 2013
Reference Type
BACKGROUND
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.
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BACKGROUND
Anthony 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.
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BACKGROUND
Tang 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.
Reference Type
BACKGROUND
Smith 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.
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BACKGROUND
Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.
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BACKGROUND
Weiss 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.
Reference Type
BACKGROUND
Mangram 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.
Reference Type
BACKGROUND
Martone 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.
Reference Type
BACKGROUND
Gaynes 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.
Reference Type
BACKGROUND
Astagneau 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.
Reference Type
BACKGROUND
Kirkland 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.
Reference Type
BACKGROUND
de 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.
Reference Type
BACKGROUND
Measures displayed on Hospital Compare. 2013. Available at: ttp://www.medicare.gov/hospitalcompare /Data/Measures-Displayed.html. Accessed March 22, 2013.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Fujii T, Tabe Y, Yajima R, Yamaguchi S, Tsutsumi S, Asao T, Kuwano H. Effects of subcutaneous drain for the prevention of incisional SSI in high-risk patients undergoing colorectal surgery. Int J Colorectal Dis. 2011 Sep;26(9):1151-5. doi: 10.1007/s00384-011-1228-2. Epub 2011 May 7.
Reference Type
BACKGROUND
Reid K, Pockney P, Draganic B, Smith SR. Barrier wound protection decreases surgical site infection in open elective colorectal surgery: a randomized clinical trial. Dis Colon Rectum. 2010 Oct;53(10):1374-80. doi: 10.1007/DCR.0b013e3181ed3f7e.
Reference Type
BACKGROUND
Edwards JP, Ho AL, Tee MC, Dixon E, Ball CG. Wound protectors reduce surgical site infection: a meta-analysis of randomized controlled trials. Ann Surg. 2012 Jul;256(1):53-9. doi: 10.1097/SLA.0b013e3182570372.
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BACKGROUND
Aimaq R, Akopian G, Kaufman HS. Surgical site infection rates in laparoscopic versus open colorectal surgery. Am Surg. 2011 Oct;77(10):1290-4. doi: 10.1177/000313481107701003.
Reference Type
BACKGROUND
Schwenk W, Haase O, Neudecker J, Muller JM. Short term benefits for laparoscopic colorectal resection. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003145. doi: 10.1002/14651858.CD003145.pub2.
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BACKGROUND
Kang CY, Halabi WJ, Luo R, Pigazzi A, Nguyen NT, Stamos MJ. Laparoscopic colorectal surgery: a better look into the latest trends. Arch Surg. 2012 Aug;147(8):724-31. doi: 10.1001/archsurg.2012.358.
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BACKGROUND
Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.
Reference Type
BACKGROUND
Reddix RN Jr, Leng XI, Woodall J, Jackson B, Dedmond B, Webb LX. The effect of incisional negative pressure therapy on wound complications after acetabular fracture surgery. J Surg Orthop Adv. 2010 Summer;19(2):91-7.
Reference Type
BACKGROUND
Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
Reference Type
BACKGROUND
Fleischmann W, Lang E, Russ M. [Treatment of infection by vacuum sealing]. Unfallchirurg. 1997 Apr;100(4):301-4. doi: 10.1007/s001130050123. German.
Reference Type
BACKGROUND
Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
Reference Type
BACKGROUND
Suissa D, Danino A, Nikolis A. Negative-pressure therapy versus standard wound care: a meta-analysis of randomized trials. Plast Reconstr Surg. 2011 Nov;128(5):498e-503e. doi: 10.1097/PRS.0b013e31822b675c.
Reference Type
BACKGROUND
Colli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011 Dec 6;6:160. doi: 10.1186/1749-8090-6-160.
Reference Type
BACKGROUND
Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.
Reference Type
BACKGROUND
Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9.
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BACKGROUND
Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
Reference Type
BACKGROUND
Benech A, Arcuri F, Poglio G, Brucoli M, Guglielmetti R, Crespi MC, Pia F. Vacuum-assisted closure therapy in reconstructive surgery. Acta Otorhinolaryngol Ital. 2012 Jun;32(3):192-7.
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BACKGROUND
Orgill DP, Manders EK, Sumpio BE, Lee RC, Attinger CE, Gurtner GC, Ehrlich HP. The mechanisms of action of vacuum assisted closure: more to learn. Surgery. 2009 Jul;146(1):40-51. doi: 10.1016/j.surg.2009.02.002. Epub 2009 Apr 19. No abstract available.
Reference Type
BACKGROUND
Guidance for Industry. Chronic Cutaneous Ulcer and Burn Wounds-Developing Products for Treatment (Draft Guidance). Rockville,MD, U.S. Department of Health and Human Services, 2000, p. 15
Reference Type
BACKGROUND
Surgical Site Infection (SSI) Event. Centers for Disease Control, 2015
Reference Type
BACKGROUND
Other Identifiers
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14-259
Identifier Type: -
Identifier Source: org_study_id
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