Is the NPWTi Better Than the Conventional NPWT

Postoperative Wound Infection Deep Incisional Surgical Site Clinical Trial

Official title:

NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014788
• Other study ID #: 20.08.1964
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2018
• Est. completion date: July 2024

Study information

• Verified date: August 2023
• Source: Military Medical Academy
• Contact: Georgi Popivanov
• Phone: +354885521241
• Email: gerasimpopivanov[@]rocketmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Postoperative Wound Infection Deep Incisional Surgical Site
• Postoperative Wound Infection Superficial Incisional
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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.
• Conventional NPWT
Conventional NPWT

Locations

Country	Name	City	State
Bulgaria	Department of Sugery	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Military Medical Academy

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication of the infection	(negative microbiology or bacterial count < 103)	6 weeks
Primary	the rate of wound closure	the wound closure by suture or flap	6 weeks
Primary	30-day recurrence rate	30-day recurrence rate of the infection	30 days after discharge
Secondary	hospital stay	hospital stay in days	6 weeks
Secondary	number of OR visits	number of OR visits and dressing changes under general anesthesia	6 weeks
Secondary	time to wound closure	the time elapsed from the start of the treatment to wound closure	6 weeks