Is the NPWTi Better Than the Conventional NPWT

NCT06014788 | Unknown DMC

• 1 other identifier: 20.08.1964
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NPWTi; conventional NPWT; superficial and deep SSIs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• hospital stay

  6 weeks

• number of OR visits

  6 weeks

• time to wound closure

  6 weeks

Study Arms (2)

NPWTi

EXPERIMENTAL

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

conventional NPWT

ACTIVE COMPARATOR

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

Interventions

NPWTi DEVICE

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.

NPWTi

Conventional NPWT DEVICE

Conventional NPWT

conventional NPWT

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Military Medical Academy, Bulgaria: lead

Study Sites (1)

Department of Sugery

Sofia, 1606, Bulgaria

RECRUITING

Study Officials

• Ventsislav Mutafchiyski, DSc, FACS

  Military Medical Academy, Bulgaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgi Popivanov

CONTACT

+354885521241; gerasimpopivanov@rocketmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 28, 2023
• Study Start: January 17, 2018
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)