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

NCT05455801 | Completed

• 1 other identifier: pNPWTHUCA
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• surgical site complications

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

  30 days after surgery

Secondary Outcomes (1)

• length of hospital stay

  30 days

Study Arms (2)

negative wound therapy group

EXPERIMENTAL

those who receive negative pressure therapy

Device: negative preassure wound therapy

conventional dressing group

NO INTERVENTION

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

Interventions

negative preassure wound therapy DEVICE

wound treated with negative pressure therapy dressing

negative wound therapy group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Central de Asturias: lead

Study Sites (1)

María Moreno Gijón

Oviedo, Principality of Asturias, 33009, Spain

Location

Related Publications (10)

• 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.

  PMID: 35584763 BACKGROUND

• 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.

  PMID: 34794257 BACKGROUND

• 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.

  PMID: 34722767 BACKGROUND

• 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.

  PMID: 34670966 BACKGROUND

• 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.

  PMID: 34543711 BACKGROUND

• 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.

  PMID: 34384325 BACKGROUND

• 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.

  PMID: 34110077 BACKGROUND

• 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.

  PMID: 34009506 BACKGROUND

• 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.

  PMID: 33844934 BACKGROUND

• 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.

  PMID: 33837948 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 13, 2022
• Study Start: March 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)