Is the NPWTi Better Than the Conventional NPWT

NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections

The goal of this clinical trial is to compare the effectiveness of NPWTi and NPWT in superficial and deep surgical site infections using an improvised system with continuous lavage with saline and chlorhexidine. The main question it aims to answer is whether the NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional NPWT.

Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent infections and the number of reoperations, shortens the hospital stay, and alleviates the burden on the hospital staff in comparison to the conventional NPWT.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Wound Infection Superficial Incisional; Postoperative Wound Infection Deep Incisional Surgical Site
• Intervention / Treatment: Device: NPWTi; Device: Conventional NPWT

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgi Popivanov; Phone Number: +354885521241; Email: gerasimpopivanov@rocketmail.com

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1606
    • Recruiting
    • Department of Sugery
    • Contact: Georgi Popivanov, PhD; Phone Number: +354885521241; Email: gerasimpopivanov@rocketmail.com
    • Contact: Kirien Kjossev, PhD; Email: kirienkt@gmail.com
    • Principal Investigator: Ventsislav Mutafchiyski, DSc, FACS
    • Sub-Investigator: Kirien Kjossev, PhD
    • Sub-Investigator: Dimitar Penchev, MD
    • Sub-Investigator: Daniel Stefanov, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults over 18 years
• superficial or deep SSIs after laparotomy or laparoscopic surgery

Exclusion Criteria:

• persons < 18 years
• documented inherited or acquired coagulation disorders or platelet deficiency
• presence of deep space infection (intra-abdominal abscess or ongoing peritonitis)
• prosthetic material infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPWTi; The whole wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg. The dressing changes were performed every 48-72 hours.	Device: NPWTi; The wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg.
Active Comparator: conventional NPWT; The wound was filled with black foam (Granufoam®, KCI) and covered with plastic folio. A continuous pressure of 125 mmHg was applied using the hospital suction system. The dressing changes were performed every 48 hours.	Device: Conventional NPWT; Conventional NPWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication of the infection	(negative microbiology or bacterial count < 103)	6 weeks
the rate of wound closure	the wound closure by suture or flap	6 weeks
30-day recurrence rate	30-day recurrence rate of the infection	30 days after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital stay	hospital stay in days	6 weeks
number of OR visits	number of OR visits and dressing changes under general anesthesia	6 weeks
time to wound closure	the time elapsed from the start of the treatment to wound closure	6 weeks

Collaborators and Investigators

• Sponsor: Military Medical Academy
• Investigators: Principal Investigator: Ventsislav Mutafchiyski, DSc, FACS, Military Medical Academy

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: NPWTi; conventional NPWT; superficial and deep SSIs
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: 20.08.1964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No