Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair

NCT05050786 | Unknown FDA Device

• 1 other identifier: PROPRESS
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine the effect of using Negative Pressure Wound Therapy (NPWT) compared with standard wound dressing among patients undergoing elective open surgery for incisional hernia. The study's main hypothesis is that NPWT will decrease the post-operative incidence of surgical site infections and also improve the patients' quality of life including less scar-related pain and higher cosmetic satisfaction.

Conditions

Incisional Hernia; Surgical Wound Infection; Surgical Site Infection; Quality of Life

Keywords

negative wound pressure therapy; incisional hernia repair; closed incision; randomized clinical trial; surgical site infection; surgical wound infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (SSI)

  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 Outcomes (3)

• Pooled Incidence of Surgical Site Occurence

  This will be evaluated at the 30 day follow up contact

• Patient-reported pain and satisfaction with the scar at 30-day follow-up

  This will be evaluated at the 30 day follow up contact

• Patient-reported Hernia-related Quality of life score at 30-day follow-up

  This will be evaluated at the 30 day follow up contact

Study Arms (2)

Standard wound dressing

ACTIVE COMPARATOR

Other: Standard Wound Dressing

Negative Pressure Wound Therapy (NPWT)

EXPERIMENTAL

Device: Negative Wound Pressure Therapy (Prevena(TM))

Interventions

Negative Wound Pressure Therapy (Prevena(TM)) DEVICE

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.

Negative Pressure Wound Therapy (NPWT)

Standard Wound Dressing OTHER

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.

Standard wound dressing

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective open incisional hernia repair

You may not qualify if:

• active superficial or deep wound infection
• inability to provide informed consent

Sponsors & Collaborators

• Kristian Kiim Jensen: lead

Study Sites (1)

Kristian Schaumburg Kiim

Copenhagen NV, Copenhagen, DK-2400, Denmark

Location

Related Publications (11)

• 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.

  PMID: 24030572 BACKGROUND

• 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.

  PMID: 28410761 BACKGROUND

• 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.

  PMID: 27609528 BACKGROUND

• 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.

  PMID: 28088597 BACKGROUND

• 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.

  PMID: 31860549 BACKGROUND

• 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.

  PMID: 15253184 BACKGROUND

• 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.

  PMID: 25194761 BACKGROUND

• 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.

  PMID: 18338205 BACKGROUND

• 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.

  PMID: 31082899 BACKGROUND

• 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.

  PMID: 27926575 BACKGROUND

• Marckmann M, Henriksen NA, Krarup PM, Helgstrand F, Vester-Glowinski P, Christoffersen MW, Kiim KS. Effect of standard wound dressing versus prophylactic closed incision negative-pressure therapy on surgical-site infection after open incisional hernia repair: multicentre randomized clinical trial. Br J Surg. 2025 Nov 29;112(12):znaf230. doi: 10.1093/bjs/znaf230.

  PMID: 41316999 DERIVED

Related Links

• Definition of Surgical Site Infection (SSI) on page 10
• Website for generating sequences with varying block sizes for randomization

MeSH Terms

Conditions

Incisional Hernia; Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Wound Infection; Infections

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Mads Marckmann, MD

  Digestive Disease Center, Bispebjerg Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristian S Kiim, MD, PHD

CONTACT

004528720172; mail@kristiankiim.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: January 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

DK (1)