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Is the NPWTi Better Than the Conventional NPWT

Primary Purpose

Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site

Status
Recruiting
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
NPWTi
Conventional NPWT
Sponsored by
Military Medical Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Wound Infection Superficial Incisional focused on measuring NPWTi, conventional NPWT, superficial and deep SSIs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of SugeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NPWTi

conventional NPWT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

eradication of the infection
(negative microbiology or bacterial count < 103)
the rate of wound closure
the wound closure by suture or flap
30-day recurrence rate
30-day recurrence rate of the infection

Secondary Outcome Measures

hospital stay
hospital stay in days
number of OR visits
number of OR visits and dressing changes under general anesthesia
time to wound closure
the time elapsed from the start of the treatment to wound closure

Full Information

First Posted
July 28, 2023
Last Updated
September 15, 2023
Sponsor
Military Medical Academy
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1. Study Identification

Unique Protocol Identification Number
NCT06014788
Brief Title
Is the NPWTi Better Than the Conventional NPWT
Official Title
NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Military Medical Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Infection Superficial Incisional, Postoperative Wound Infection Deep Incisional Surgical Site
Keywords
NPWTi, conventional NPWT, superficial and deep SSIs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NPWTi
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional NPWT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NPWTi
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional NPWT
Intervention Description
Conventional NPWT
Primary Outcome Measure Information:
Title
eradication of the infection
Description
(negative microbiology or bacterial count < 103)
Time Frame
6 weeks
Title
the rate of wound closure
Description
the wound closure by suture or flap
Time Frame
6 weeks
Title
30-day recurrence rate
Description
30-day recurrence rate of the infection
Time Frame
30 days after discharge
Secondary Outcome Measure Information:
Title
hospital stay
Description
hospital stay in days
Time Frame
6 weeks
Title
number of OR visits
Description
number of OR visits and dressing changes under general anesthesia
Time Frame
6 weeks
Title
time to wound closure
Description
the time elapsed from the start of the treatment to wound closure
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgi Popivanov
Phone
+354885521241
Email
gerasimpopivanov@rocketmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ventsislav Mutafchiyski, DSc, FACS
Organizational Affiliation
Military Medical Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sugery
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgi Popivanov, PhD
Phone
+354885521241
Email
gerasimpopivanov@rocketmail.com
First Name & Middle Initial & Last Name & Degree
Kirien Kjossev, PhD
Email
kirienkt@gmail.com
First Name & Middle Initial & Last Name & Degree
Ventsislav Mutafchiyski, DSc, FACS
First Name & Middle Initial & Last Name & Degree
Kirien Kjossev, PhD
First Name & Middle Initial & Last Name & Degree
Dimitar Penchev, MD
First Name & Middle Initial & Last Name & Degree
Daniel Stefanov, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Is the NPWTi Better Than the Conventional NPWT

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