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

NCT ID: NCT05455801

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2021-07-31

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.

Conditions

Surgical Site Infection; Complication,Postoperative; Surgical Wound Infection; Surgical Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

negative wound therapy group

those who receive negative pressure therapy

Group Type: EXPERIMENTAL

negative preassure wound therapy

Intervention Type: DEVICE

wound treated with negative pressure therapy dressing

conventional dressing group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

negative preassure wound therapy

wound treated with negative pressure therapy dressing

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Central de Asturias

OTHER

Sponsor Role: lead

Responsible Party

María Moreno Gijon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

María Moreno Gijón

Oviedo, Principality of Asturias, Spain

Countries

Spain

References

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Reference Type: BACKGROUND

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Other Identifiers

pNPWTHUCA

Identifier Type: -

Identifier Source: org_study_id