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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05455801
Enrollment
271
Registered
2022-07-13
Start date
2019-03-01
Completion date
2021-07-31
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

surgical site infections, prophylaxis, negative pressure wound therapy, abdominal surgery

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.

Interventions

DEVICEnegative preassure wound therapy

wound treated with negative pressure therapy dressing

Sponsors

Hospital Universitario Central de Asturias
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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 infections

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
surgical site complications30 days after surgerydevelopment of surgical site infection of wound seroma, skin dehiscence, wound necrosis

Secondary

MeasureTime frameDescription
length of hospital stay30 daysdays

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026