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Is the NPWTi Better Than the Conventional NPWT

NCT06014788 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-18

No results posted yet for this study

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

Interventions

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.

DEVICE

Conventional NPWT

Conventional NPWT

Sponsors & Collaborators

  • Military Medical Academy, Bulgaria

    lead OTHER

Principal Investigators

  • Ventsislav Mutafchiyski, DSc, FACS · Military Medical Academy, Bulgaria

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2024-06-30
Completion
2024-07-31

Countries

  • Bulgaria

Study Locations

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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 NCT06014788 on ClinicalTrials.gov