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Surgical Site InfectionNCT05455801

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

A study testing negative preassure wound therapy in people with Surgical Site Infection and Complication,Postoperative, run by Hospital Universitario Central de Asturias at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 years and older
What is being tested?
negative preassure wound therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
271 participants
Where
1 siteSpain
Study dates
1 Mar 2019to 31 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • María Moreno Gijón

    Oviedo, Principality of Asturias, 33009

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
negative preassure wound therapy
Keywords
surgical site infections, prophylaxis, negative pressure wound therapy, abdominal surgery
Medical subject headings
Surgical Wound Infection, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • negative preassure wound therapyDevice

    wound treated with negative pressure therapy dressing

Study groups in NCT05455801
Study groupRoleWhat they receive
negative wound therapy groupExperimentalthose who receive negative pressure therapy
Receives: Device: negative preassure wound therapy
conventional dressing groupNo interventionthose patients who heal with conventional dressing, therefore negative pressure therapy is not applied

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surgical site complications

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

    Measured: 30 days after surgery

Secondary outcomes (1)

  1. length of hospital stay

    days

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start1 Mar 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
271 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455801
Sponsor's protocol ID
pNPWTHUCA
Status last verified
Jul 2022
First submitted
1 Jul 2022
Last updated
13 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bueno-Lledo J, Martinez-Hoed J, Pous-Serrano S. Negative pressure therapy in abdominal wall surgery. Cir Esp (Engl Ed). 2022 Aug;100(8):464-471. doi: 10.1016/j.cireng.2022.05.017. Epub 2022 May 16.

    PubMed 35584763

  • Wang XX, Xiang Y, Meng Y, Ma B, Hu XY, Tang HT, Ben DF, Xiao SC. [Clinical effects of negative pressure wound therapy in treating the poor healing of incisions after different abdominal operations]. Zhonghua Shao Shang Za Zhi. 2021 Nov 20;37(11):1054-1060. doi: 10.3760/cma.j.cn501120-20210518-00194. Chinese.

    PubMed 34794257

  • Mehdorn M, Jansen-Winkeln B. Modified Incisional Negative Pressure Wound Therapy Increases Seroma Evacuation: An Ex Vivo Model. Biomed Res Int. 2021 Oct 21;2021:5846724. doi: 10.1155/2021/5846724. eCollection 2021.

    PubMed 34722767

  • Ayuso SA, Elhage SA, Okorji LM, Kercher KW, Colavita PD, Heniford BT, Augenstein VA. Closed-Incision Negative Pressure Therapy Decreases Wound Morbidity in Open Abdominal Wall Reconstruction With Concomitant Panniculectomy. Ann Plast Surg. 2022 Apr 1;88(4):429-433. doi: 10.1097/SAP.0000000000002966.

    PubMed 34670966

  • Zhao AH, Kwok CHR, Jansen SJ. How to Prevent Surgical Site Infection in Vascular Surgery: A Review of the Evidence. Ann Vasc Surg. 2022 Jan;78:336-361. doi: 10.1016/j.avsg.2021.06.045. Epub 2021 Sep 17.

    PubMed 34543711

  • Gong S, Yang J, Lu T, Tian H, Huang Y, Song S, Lei C, Yang W, Yang K, Guo T. Incisional negative pressure wound therapy for clean-contaminated wounds in abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. Expert Rev Gastroenterol Hepatol. 2021 Nov;15(11):1309-1318. doi: 10.1080/17474124.2021.1967143. Epub 2021 Aug 18.

    PubMed 34384325

  • Leuchter M, Hitzbleck M, Schafmayer C, Philipp M. Use of incisional preventive negative pressure wound therapy in open incisional hernia repair: Who benefits? Wound Repair Regen. 2021 Sep;29(5):759-765. doi: 10.1111/wrr.12948. Epub 2021 Jun 10.

    PubMed 34110077

  • Seaman AP, Sarac BA, ElHawary H, Janis JE. The effect of negative pressure wound therapy on surgical site occurrences in closed incision abdominal wall reconstructions: a retrospective single surgeon and institution study. Hernia. 2021 Dec;25(6):1549-1555. doi: 10.1007/s10029-021-02427-3. Epub 2021 May 19.

    PubMed 34009506

  • Almansa-Saura S, Lopez-Lopez V, Eshmuminov D, Schneider M, Castellanos-Escrig G, Rodriguez-Valiente M, Crespo MJ, von der Groeben M, Lehmann K, Robles-Campos R. Prophylactic Use of Negative Pressure Therapy in General Abdominal Surgery: A Systematic Review and Meta-Analysis. Surg Infect (Larchmt). 2021 Oct;22(8):854-863. doi: 10.1089/sur.2020.407. Epub 2021 Apr 12.

    PubMed 33844934

  • Roos E, Douissard J, Abbassi Z, Buchs NC, Toso C, Ris F, Meyer J. Prophylactic negative-pressure wound therapy for prevention of surgical site infection in abdominal surgery: a nationwide cross-sectional survey. Updates Surg. 2021 Oct;73(5):1983-1988. doi: 10.1007/s13304-021-01017-3. Epub 2021 Apr 10.

    PubMed 33837948

Questions about this trial

What is this clinical trial studying?

A study testing negative preassure wound therapy in people with Surgical Site Infection and Complication,Postoperative, run by Hospital Universitario Central de Asturias at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

surgical site complications (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455801, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.

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