Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

NCT03716687 | Terminated

• 1 other identifier: OGYÉI/15347-9/2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen. NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness. In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

Conditions

Surgical Wound; Wound Dehiscence, Surgical; Surgical Site Infection; Dehiscence of Internal Surgical Wound

Keywords

negative pressure wound closure; surgical site infection; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)

  30 days

Secondary Outcomes (1)

• Full thickness abdominal wall dehiscence, requiring re-operation

  30 days

Study Arms (2)

ciNPWT

EXPERIMENTAL

Prophylactic negative pressure wound dress (Hartmann) is set up for 5 days right after operation. Continous -90 Hgmm negative pressure mode selected. No change of wound dress until 5 days completed.

Device: Prophylactic negative pressure wound dressing after laparotomy

Traditional wound dressing

NO INTERVENTION

Control group with traditional, dry laparotomy wound dressing.

Interventions

Prophylactic negative pressure wound dressing after laparotomy DEVICE

Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.

ciNPWT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
• Surgical wound type III or IV..

You may not qualify if:

• Patients not giving informed consent.
• Patients requiring open abdominal wound care.
• Patients with abdominal wall malignancy,
• Patients with peritoneal carcinomatosis,
• Patients who are planned for second look laparotomy within 5 days,
• Patients with less thank 3 month life expectancy.
• Patients who are operated with existing wound infection

Sponsors & Collaborators

• St. Borbala Hospital: lead
• Semmelweis University: collaborator
• Department of Surgery, Jahn Ferend Dél-Pesti Kórház és Rendelőintézet, Budapest: collaborator
• Department of Surgery, Somogy Megyei Kaposi Mór Oktatókórház, Kaposvár: collaborator
• Institute of Surgery, University of Debrecen: collaborator
• Department of Surgery, University of Szeged: collaborator
• Department of Surgery, Uzsoki Utcai Kórház és Rendelőintézet, Budapest: collaborator
• Department of Surgery, Markusovszky Egyetemi Oktatókórház, Szombathely: collaborator
• Department of Surgery, Bács-Kiskun Megyei Kórház, Kecskemét: collaborator
• Department of Surgery, Kenézy Gyula Egyetemi Oktatókórház, Debrecen: collaborator
• Department of Surgery, Szent Rókus Kórház, Baja: collaborator
• Department of Surgery, St. Borbala hospital, Tatabanya: collaborator

Study Sites (1)

St. Borbala Hospital

Tatabánya, 2800, Hungary

Location

Related Publications (6)

• Sahebally SM, McKevitt K, Stephens I, Fitzpatrick F, Deasy J, Burke JP, McNamara D. Negative Pressure Wound Therapy for Closed Laparotomy Incisions in General and Colorectal Surgery: A Systematic Review and Meta-analysis. JAMA Surg. 2018 Nov 1;153(11):e183467. doi: 10.1001/jamasurg.2018.3467. Epub 2018 Nov 21.

  PMID: 30267040 RESULT

• Curran T, Alvarez D, Pastrana Del Valle J, Cataldo TE, Poylin V, Nagle D. Prophylactic closed-incision negative-pressure wound therapy is associated with decreased surgical site infection in high-risk colorectal surgery laparotomy wounds. Colorectal Dis. 2019 Jan;21(1):110-118. doi: 10.1111/codi.14350. Epub 2018 Aug 20.

  PMID: 30047611 RESULT

• Gachabayov M, You K, Sullivan R, Bergamaschi R. A Retrospective Cohort Study to Determine Predictive Factors for Abdominal Wound Disruption Following Colorectal Surgery. Ostomy Wound Manage. 2018 Apr;64(4):22-29.

  PMID: 29718814 RESULT

• Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.

  PMID: 28885895 RESULT

• Athanasiou AN, Spartalis M, Spartalis E. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds After Abdominal Operations: What We Really Know? Ann Surg. 2018 Jul;268(1):e19-e20. doi: 10.1097/SLA.0000000000002413. No abstract available.

  PMID: 28692475 RESULT

• Herczeg A, Szijarto A, Fulop A, Varga K, Marton J, Loderer Z, Mohos B, Pancel B, Szendrenyi V, Lazar G, Libor L, Kaposztas Z, Mathe E, Bursics A, Kecskedi B, Sikorszki L, Venczel L, Banky B. Prophylactic Negative Pressure Wound Therapy Reduces Superficial Surgical Site Infection Risk of Emergency Surgery Patients: Results of a Multicenter Randomised Prospective Clinical Trial. Int Wound J. 2025 Jul;22(7):e70718. doi: 10.1111/iwj.70718.

  PMID: 40605477 DERIVED

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Dehiscence; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Surgery, St. Borbala Hospital

Model Details: 50-50% randomisation into interventional (ciNPWT) and control (traditionaltreatment) groups.

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)