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Prophylactic Negative Pressure Wound Therapy for Patients Undergoing Incisional Hernia Repair

NCT05050786 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-09-21

No results posted yet for this study

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

Interventions

DEVICE

Negative Wound Pressure Therapy (Prevena(TM))

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.

OTHER

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.

Sponsors & Collaborators

  • Kristian Kiim Jensen

    lead OTHER

Principal Investigators

  • Mads Marckmann, MD · Digestive Disease Center, Bispebjerg Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2023-08-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • Denmark

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05050786 on ClinicalTrials.gov