Is the NPWTi Better Than the Conventional NPWT

Military Medical Academy, Bulgaria

Status: Enrolling

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

Treatments: Device: Conventional NPWT; Device: NPWTi

Study type: Interventional

Funder types: Other

Identifiers

NCT06014788

20.08.1964

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

NPWTi

Experimental group

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.

Treatment:

Device: NPWTi

conventional NPWT

Active Comparator group

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.

Treatment:

Device: Conventional NPWT