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Completed

NCT Number: NCT05455801

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

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.

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Key information

Conditions

Surgical Site Infection Complication,Postoperative Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Complication Surgical Wound Infection Wound Infection

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

María Moreno Gijón

Oviedo, Principality of Asturias, 33009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

negative preassure wound therapy

Device

wound treated with negative pressure therapy dressing

Primary outcomes

  1. surgical site complications

    Time frame: 30 days after surgery

    development of surgical site infection of wound seroma, skin dehiscence, wound necrosis

Secondary outcomes

  1. length of hospital stay

    Time frame: 30 days

    days

Sponsors and collaborators

Lead sponsor

Hospital Universitario Central de Asturias

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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