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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

Primary Purpose

Surgical Site Infection, Complication,Postoperative, Surgical Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
negative preassure wound therapy
Sponsored by
Hospital Universitario Central de Asturias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infection focused on measuring surgical site infections, prophylaxis, negative pressure wound therapy, abdominal surgery

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • María Moreno Gijón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

negative wound therapy group

conventional dressing group

Arm Description

those who receive negative pressure therapy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

length of hospital stay
days

Full Information

First Posted
July 1, 2022
Last Updated
July 8, 2022
Sponsor
Hospital Universitario Central de Asturias
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1. Study Identification

Unique Protocol Identification Number
NCT05455801
Brief Title
Study to Analyze the Surgical Site Infections in a Group of Patients Who Were Randomly Applied a Negative Pressure Therapy Dressing Versus Conventional Dressing
Official Title
Randomized Study on the Efficacy of Negative Pressure Wound Therapy (NPWT) in the Prevention of Surgical Site Complications
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Central de Asturias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Complication,Postoperative, Surgical Wound Infection, Surgical Complication
Keywords
surgical site infections, prophylaxis, negative pressure wound therapy, abdominal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
negative wound therapy group
Arm Type
Experimental
Arm Description
those who receive negative pressure therapy
Arm Title
conventional dressing group
Arm Type
No Intervention
Arm Description
those patients who heal with conventional dressing, therefore negative pressure therapy is not applied
Intervention Type
Device
Intervention Name(s)
negative preassure wound therapy
Intervention Description
wound treated with negative pressure therapy dressing
Primary Outcome Measure Information:
Title
surgical site complications
Description
development of surgical site infection of wound seroma, skin dehiscence, wound necrosis
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
length of hospital stay
Description
days
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
María Moreno Gijón
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35584763
Citation
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.
Results Reference
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PubMed Identifier
34794257
Citation
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.
Results Reference
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PubMed Identifier
34722767
Citation
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.
Results Reference
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PubMed Identifier
34670966
Citation
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.
Results Reference
background
PubMed Identifier
34543711
Citation
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.
Results Reference
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PubMed Identifier
34384325
Citation
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.
Results Reference
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PubMed Identifier
34110077
Citation
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.
Results Reference
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PubMed Identifier
34009506
Citation
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.
Results Reference
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PubMed Identifier
33844934
Citation
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.
Results Reference
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PubMed Identifier
33837948
Citation
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.
Results Reference
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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

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