- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05050786
Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair (PROPRESS)
Prophylactic Negative-Pressure Wound Treatment (NPWT) for Patients Undergoing Elective Open Incisional Hernia Repair: the PROPRESS Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
In recent years, negative pressure wound therapy (NPWT) has been utilized for the treatment of complicated wounds within orthopedic and vascular surgery, whereas incisions after abdominal surgery have not been treated with prophylactic negative pressure wound treatment to the same extent. Patients undergoing incisional hernia repair per definition have elicited insufficient wound healing (i.e. the hernia), and often carry comorbidities such as diabetes, obesity and a history of smoking, leaving them at a high risk of developing wound complications. Despite efforts to reduce this risk, the incidence remains as high as 50% in some series. Wound complications are especially concerning in patients undergoing incisional hernia repair, as a foreign body (synthetic polypropylene mesh) is placed in the abdominal wall during the procedure. Wound complications are directly associated with an increased risk of hernia recurrence, which reduces the patients' quality of life and has severe socioeconomic costs including a higher risk of prolonged hospital admission, re-operation, re-admission and increased mortality (2). The aim of this trial is to examine the effects of prophylactic NPWT on postoperative wound complications after open incisional hernia repair compared with standard care, i.e. an operative dressing. It is our hypothesis that NPWT significantly reduces the incidence of surgical site infections (SSI) as defined by the Center for Disease Control.
Since Bispebjerg Hospital in Denmark is the regional center for complex hernias, this is one of the few sites where a randomized trial including 110 patients undergoing open incisional hernia repair is feasible. To date, only five randomized controlled trials of prophylactic NPWT for closed abdominal incisions have been published. In the most recent meta-analysis of these trials, there was no reduced risk of wound complications in patients treated with NPWT, however results indeed seemed subjective to type-II error (relative risk 0.56 (95% confidence interval 0.30-1.03, P = 0.064). Thus, adding another randomized trial expectedly will alter the conclusion of the next meta-analysis.
The study type is a randomized controlled trial (RCT) comprising two treatment groups, i.e. one of the following:
- STANDARD CARE After skin closure, a standard operative dressing is applied in the entire length of the incision. This operative dressing is removed in the morning of postoperative day two. Only in the case of blood or serous fluid mandating changing of the dressing, will this be done prior to postoperative day 2.
- INTERVENTION After skin closure, NPWT in the form of Prevena™ (KCI/Acelity, San Antonia, TX, USA) is applied using the following technique: The sterile foam dressing is removed from the package and placed on the incision in the entire length, on top of which the sterile dressing is placed, ensuring air tightness. An appropriate hole in the dressing is cut at the center of the dressing and the tube for the interface pad is connected and a negative pressure of 125mmHg is applied. The Prevena™ system is removed on the morning of postoperative day 3.
Patients are included in the study during the planning of surgery in the outpatient clinic or within a week before surgery at the planned visit in the department of surgery. Patients are randomized to intervention or standard treatment in a 1:1 allocation ratio, which will be performed using computer generated sequences with varying block sizes (http://www.sealedenvelope.com/). This randomization will generate randomization and code envelopes and is carried out by a physician not otherwise involved in the study. On the day of surgery, the patients are given a randomization number. Corresponding randomization envelopes contain information about the intervention the patient is to receive and are thus opened during surgery, i.e. immediately after closure of the linea alba, whereas the code envelopes will be opened at the time of data analysis after all included patients have completed 30-day follow up. Based on the average number of elective open incisional hernia repairs at the study's operating site, the patient recruitment is expected to take 1 to 2 years.
PARTICIPANTS
The following baseline data are registered for each participant:
- Age [nominal: number]
- Sex [categorical: Male, Female]
- Number of previous abdominal operations [nominal: number]
- Number of previous incisional hernia repairs [nominal: number]
- Smoking status [categorical: Active smoker, Non-smoker]
- BMI [kg/m2]
- Chronic obstructive pulmonary disease [categorical: Yes, No]
- Diabetes [categorical: Yes, No]
- American Society of Anesthesiology (ASA) class [categorical: 1, 2, 3, 4, 5]
- Site of incisional hernia [categorical: Midline, Upper left, Lower left, Upper right, Lower right, Other]
- Orientation of hernia incision [categorical: Horizontal, Vertical]
- Bleeding disorder + anticoagulative medication [categorical: Yes, No]
- Serum albumin level [numerical: g/L]
- Maximal horizontal fascial defect [numerical: centimeters]
- Maximal vertical fascial defect [numerical: centimeters]
- Botox [categorical: Yes, No]
Perioperative established variables
- Type of procedure/repair [categorical: Rives-Stoppa, RS+TAR, onlay, IPOM, RS+ECS, other]
- Operative time [numerical: minutes]
- Length of incision [numerical: centimeters]
- Contamination grade [categorical: clean, clean-contaminated, contaminated, dirty]
- Type of mesh
- Commentary option (e.g. perioperative complications)
ETHICAL CONSIDERATIONS This trial aim to improve the treatment of patients undergoing open abdominal surgery by reducing the incidence of wound complications. We hypothesize that the intervention will be an improvement compared with the standard treatment currently offered, without any severe side-effects. This includes both in terms of the expected reduction in wound complication incidence as well as an increase in patient quality of life. Thus, the expected benefits from participation in the current trials outweigh any potential drawbacks and is therefore considered ethical appropriate. Lastly, the trial conforms to the Helsinki Declaration.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristian S Kiim, MD, PHD
- Phone Number: 004528720172
- Email: mail@kristiankiim.dk
Study Locations
-
-
Copenhagen
-
Copenhagen NV, Copenhagen, Denmark, DK-2400
- Kristian Schaumburg Kiim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing elective open incisional hernia repair
Exclusion Criteria:
- active superficial or deep wound infection
- inability to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard wound dressing
|
After skin closure, a standard operative dressing is applied in the entire length of the incision.
This operative dressing is removed in the morning of postoperative day two.
Only in the case of blood or serous fluid mandating changing of the dressing, will this be done prior to postoperative day 2.
|
Experimental: Negative Pressure Wound Therapy (NPWT)
|
After skin closure, NPWT in the form of Prevena™ (KCI/Acelity, San Antonia, TX, USA) is applied using the following technique: The sterile foam dressing is removed from the package and placed on the incision in the entire length, on top of which the sterile dressing is placed, ensuring air tightness.
An appropriate hole in the dressing is cut at the center of the dressing and the tube for the interface pad is connected and a negative pressure of 125mmHg is applied.
The Prevena™ system is removed on the morning of postoperative day 3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical Site Infection (SSI)
Time Frame: The outcome will be monitored over a 30 days period post surgery. The patient is typically discharged on day 3 and will be notified of signs of infection by standard including warning signs that should lead to medical contact.
|
As defined by the Center for Disease Control
|
The outcome will be monitored over a 30 days period post surgery. The patient is typically discharged on day 3 and will be notified of signs of infection by standard including warning signs that should lead to medical contact.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pooled Incidence of Surgical Site Occurence
Time Frame: This will be evaluated at the 30 day follow up contact
|
Surgical site infection, wound hematoma, skin necrosis or superficial wound dehiscence
|
This will be evaluated at the 30 day follow up contact
|
Patient-reported pain and satisfaction with the scar at 30-day follow-up
Time Frame: This will be evaluated at the 30 day follow up contact
|
Standardized questionnaire POSAS
|
This will be evaluated at the 30 day follow up contact
|
Patient-reported Hernia-related Quality of life score at 30-day follow-up
Time Frame: This will be evaluated at the 30 day follow up contact
|
Standardized questionnaire EuraHS-QoL
|
This will be evaluated at the 30 day follow up contact
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mads Marckmann, MD, Digestive Disease Center, Bispebjerg Hospital, Denmark
Publications and helpful links
General Publications
- Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Kobayashi M, Mohri Y, Inoue Y, Okita Y, Miki C, Kusunoki M. Continuous follow-up of surgical site infections for 30 days after colorectal surgery. World J Surg. 2008 Jun;32(6):1142-6. doi: 10.1007/s00268-008-9536-6.
- O'Leary DP, Peirce C, Anglim B, Burton M, Concannon E, Carter M, Hickey K, Coffey JC. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations: A Randomized, Controlled, Open-label Trial: The P.I.C.O. Trial. Ann Surg. 2017 Jun;265(6):1082-1086. doi: 10.1097/SLA.0000000000002098.
- Kaoutzanis C, Leichtle SW, Mouawad NJ, Welch KB, Lampman RM, Wahl WL, Cleary RK. Risk factors for postoperative wound infections and prolonged hospitalization after ventral/incisional hernia repair. Hernia. 2015 Feb;19(1):113-23. doi: 10.1007/s10029-013-1155-y. Epub 2013 Sep 13.
- Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect. 2017 May;96(1):1-15. doi: 10.1016/j.jhin.2017.03.004. Epub 2017 Mar 8.
- Li PY, Yang D, Liu D, Sun SJ, Zhang LY. Reducing Surgical Site Infection with Negative-Pressure Wound Therapy After Open Abdominal Surgery: A Prospective Randomized Controlled Study. Scand J Surg. 2017 Sep;106(3):189-195. doi: 10.1177/1457496916668681. Epub 2016 Sep 8.
- Shen P, Blackham AU, Lewis S, Clark CJ, Howerton R, Mogal HD, Dodson RM, Russell GB, Levine EA. Phase II Randomized Trial of Negative-Pressure Wound Therapy to Decrease Surgical Site Infection in Patients Undergoing Laparotomy for Gastrointestinal, Pancreatic, and Peritoneal Surface Malignancies. J Am Coll Surg. 2017 Apr;224(4):726-737. doi: 10.1016/j.jamcollsurg.2016.12.028. Epub 2017 Jan 11.
- Kuper TM, Murphy PB, Kaur B, Ott MC. Prophylactic Negative Pressure Wound Therapy for Closed Laparotomy Incisions: A Meta-analysis of Randomized Controlled Trials. Ann Surg. 2020 Jan;271(1):67-74. doi: 10.1097/SLA.0000000000003435.
- Soares KC, Baltodano PA, Hicks CW, Cooney CM, Olorundare IO, Cornell P, Burce K, Eckhauser FE. Novel wound management system reduction of surgical site morbidity after ventral hernia repairs: a critical analysis. Am J Surg. 2015 Feb;209(2):324-32. doi: 10.1016/j.amjsurg.2014.06.022. Epub 2014 Aug 7.
- Javed AA, Teinor J, Wright M, Ding D, Burkhart RA, Hundt J, Cameron JL, Makary MA, He J, Eckhauser FE, Wolfgang CL, Weiss MJ. Negative Pressure Wound Therapy for Surgical-site Infections: A Randomized Trial. Ann Surg. 2019 Jun;269(6):1034-1040. doi: 10.1097/SLA.0000000000003056.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROPRESS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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