Study to Analyze the Surgical Site Infections in a Group of Patients Who Were Randomly Applied a Negative Pressure Therapy Dressing Versus Conventional Dressing

Sponsor

Hospital Universitario Central de Asturias (Other)

Overall Status

Completed

CT.gov ID

NCT05455801

Collaborator

(none)

271

Enrollment

Location

Arms

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Surgical site complications generate a series of consequences that prolong hospital stay, increase interventions and procedures, and consequently considerably increase healthcare costs. Hence, the importance of studying measures to reduce these complications and the most feared of them is surgical site infection. The objective of the study is to analyze the complications of the surgical site in a group of participante with risk factors for developing them after undergone abdominal surgery in the period described.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection Complication,Postoperative Surgical Wound Infection Surgical Complication	Device: negative preassure wound therapy	N/A

Detailed Description

All non-consecutive participants operated on in a hospital were included, both those who, based on a protocol prepared by the investigators unit, were classified as having no risk of developing complications, low risk or high risk. Partfipants classified as low and high risk, after their consent to participate in the study, entered to form part of it. This participanta were classified before surgery according to the risk factors of themselves and of the procedure, and those at risk were randomized to treatment with a negative pressure therapy dressing or no treatment, and a cure was performed with a conventional dressing. The participants classified as not at risk of complications were not included in the study. In this way the investigators tried to analyze if the intervention with the negative pressure therapy dressing reduced the complications of the surgical site.The primary objective was to analyze the reduction of surgical site infections in participants treated with negative pressure therapy compared to those treated with conventional dressing. As secondary objectives the investigators proposed to measure other complications in both groups and the hospital stay.

Study Design

Study Type:

Interventional

Actual Enrollment :

271 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomly apply a negative pressure therapy dressing in the operating room to heal a surgical wound or a conventional dressing without negative pressure in those patients at high risk of presenting complications and surgical site infectionsRandomly apply a negative pressure therapy dressing in the operating room to heal a surgical wound or a conventional dressing without negative pressure in those patients at high risk of presenting complications and surgical site infections

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Study on the Efficacy of Negative Pressure Wound Therapy (NPWT) in the Prevention of Surgical Site Complications

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: negative wound therapy group those who receive negative pressure therapy	Device: negative preassure wound therapy wound treated with negative pressure therapy dressing
No Intervention: conventional dressing group those patients who heal with conventional dressing, therefore negative pressure therapy is not applied

Arm

Intervention/Treatment

Experimental: negative wound therapy group

those who receive negative pressure therapy

Device: negative preassure wound therapy

wound treated with negative pressure therapy dressing

No Intervention: conventional dressing group

those patients who heal with conventional dressing, therefore negative pressure therapy is not applied

Outcome Measures

Primary Outcome Measures

surgical site complications [30 days after surgery]
development of surgical site infection of wound seroma, skin dehiscence, wound necrosis

Secondary Outcome Measures

length of hospital stay [30 days]
days

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with risk factors for developing surgical site complications
undergo abdominal surgery
consent of the patient to participate in the study

Exclusion Criteria:

non-consent of the patient to participate in the study
patients without risk of developing surgical site complications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	María Moreno Gijón	Oviedo	Asturias	Spain	33009

Sponsors and Collaborators

Hospital Universitario Central de Asturias

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

María Moreno Gijon, Principal Investigator, Hospital Universitario Central de Asturias

ClinicalTrials.gov Identifier:

NCT05455801

Other Study ID Numbers:

pNPWTHUCA

First Posted:

Jul 13, 2022

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by María Moreno Gijon, Principal Investigator, Hospital Universitario Central de Asturias

surgical site infections

prophylaxis

negative pressure wound therapy

abdominal surgery

Additional relevant MeSH terms:

Infections

Communicable Diseases

Surgical Wound Infection

Wound Infection

Postoperative Complications

Surgical Wound

Study Results

No Results Posted as of Jul 13, 2022