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 Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05455801
• Other study ID #: pNPWTHUCA
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2022
• Source: Hospital Universitario Central de Asturias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: July 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Complication,Postoperative
• Infections
• Postoperative Complications
• Surgical Complication
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• negative preassure wound therapy
wound treated with negative pressure therapy dressing

Locations

Country	Name	City	State
Spain	María Moreno Gijón	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. — View 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. — View Citation

Bueno-Lledó J, Martínez-Hoed J, Pous-Serrano S. Negative pressure therapy in abdominal wall surgery. Cir Esp (Engl Ed). 2022 May 16. pii: S2173-5077(22)00139-9. doi: 10.1016/j.cireng.2022.05.017. [Epub ahead of print] — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical site complications	development of surgical site infection of wound seroma, skin dehiscence, wound necrosis	30 days after surgery
Secondary	length of hospital stay	days	30 days