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Is the NPWTi Better Than the Conventional NPWT

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ClinicalTrials.gov Identifier: NCT06014788
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : September 18, 2023
Sponsor:
Information provided by (Responsible Party):
Military Medical Academy, Bulgaria

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Wound Infection Superficial Incisional Postoperative Wound Infection Deep Incisional Surgical Site Device: NPWTi Device: Conventional NPWT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. eradication of the infection [ Time Frame: 6 weeks ]
    (negative microbiology or bacterial count < 103)

  2. the rate of wound closure [ Time Frame: 6 weeks ]
    the wound closure by suture or flap

  3. 30-day recurrence rate [ Time Frame: 30 days after discharge ]
    30-day recurrence rate of the infection


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: 6 weeks ]
    hospital stay in days

  2. number of OR visits [ Time Frame: 6 weeks ]
    number of OR visits and dressing changes under general anesthesia

  3. time to wound closure [ Time Frame: 6 weeks ]
    the time elapsed from the start of the treatment to wound closure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014788


Contacts
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Contact: Georgi Popivanov +354885521241 gerasimpopivanov@rocketmail.com

Locations
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Bulgaria
Department of Sugery Recruiting
Sofia, Bulgaria, 1606
Contact: Georgi Popivanov, PhD    +354885521241    gerasimpopivanov@rocketmail.com   
Contact: Kirien Kjossev, PhD       kirienkt@gmail.com   
Principal Investigator: Ventsislav Mutafchiyski, DSc, FACS         
Sub-Investigator: Kirien Kjossev, PhD         
Sub-Investigator: Dimitar Penchev, MD         
Sub-Investigator: Daniel Stefanov, MD         
Sponsors and Collaborators
Military Medical Academy, Bulgaria
Investigators
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Principal Investigator: Ventsislav Mutafchiyski, DSc, FACS Military Medical Academy, Bulgaria
More Information
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Responsible Party: Military Medical Academy, Bulgaria
ClinicalTrials.gov Identifier: NCT06014788    
Other Study ID Numbers: 20.08.1964
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: September 18, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Military Medical Academy, Bulgaria:
NPWTi
conventional NPWT
superficial and deep SSIs
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Wound Infection
Surgical Wound Infection
 Wounds and Injuries
Disease Attributes
Pathologic Processes
Postoperative Complications