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

Not Applicable

Completed

• Conditions: Complication,Postoperative; Surgical Wound Infection; Surgical Site Infection; Surgical Complication
• Interventions: Device: negative preassure wound therapy

• Registration Number: NCT05455801
• Lead Sponsor: Hospital Universitario Central de Asturias

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.

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 Timeline

• Study Start: 2019-03-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-07-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
negative wound therapy group	negative preassure wound therapy	those who receive negative pressure therapy

Primary Outcome Measures

Name	Time	Method
surgical site complications	30 days after surgery	development of surgical site infection of wound seroma, skin dehiscence, wound necrosis

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	30 days	days

Trial Locations

Locations (1)

María Moreno Gijón; 🇪🇸 Oviedo, Asturias, Spain