Is the NPWTi Better Than the Conventional NPWT

Not Applicable

Recruiting

• Conditions: Postoperative Wound Infection Deep Incisional Surgical Site; Postoperative Wound Infection Superficial Incisional
• Interventions: Device: NPWTi; Device: Conventional NPWT

• Registration Number: NCT06014788
• Lead Sponsor: Military Medical Academy, Bulgaria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-17
• Study First Submitted: 2023-07-28
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWTi	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.
conventional NPWT	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Sugery; 🇧🇬 Sofia, Bulgaria