Is the NPWTi Better Than the Conventional NPWT

Sponsor

Military Medical Academy (Other)

Overall Status

Recruiting

CT.gov ID

NCT06014788

Collaborator

(none)

100

Enrollment

Location

Arms

77.4

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Wound Infection Superficial Incisional Postoperative Wound Infection Deep Incisional Surgical Site	Device: NPWTi Device: Conventional NPWT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 17, 2018

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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.	Device: Conventional NPWT Conventional NPWT

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: 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.

Device: Conventional NPWT

Conventional NPWT

Outcome Measures

Primary Outcome Measures

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
30-day recurrence rate [30 days after discharge]
30-day recurrence rate of the infection

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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