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

Sponsor

St. Borbala Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT03716687

Collaborator

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

100

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Wound Dehiscence, Surgical Surgical Site Infection Dehiscence of Internal Surgical Wound	Device: Prophylactic negative pressure wound dressing after laparotomy	N/A

Detailed Description

The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.

Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.

Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).

A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.

Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ciNPWT 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 Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.
No Intervention: Traditional wound dressing Control group with traditional, dry laparotomy wound dressing.

Arm

Intervention/Treatment

Experimental: ciNPWT

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

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

No Intervention: Traditional wound dressing

Control group with traditional, dry laparotomy wound dressing.

Outcome Measures

Primary Outcome Measures

Surgical site infection [30 days]
Surgical site infection requiring wound re-opening (suture removal) and open wound treatment. (Clavien-Dindo 2)

Secondary Outcome Measures

Full thickness abdominal wall dehiscence, requiring re-operation [30 days]
Full thickness abdominal wall dehiscence, requiring re-operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Borbala Hospital	Tatabánya		Hungary	2800

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Balázs Bánky PhD, Head of the Department of Surgery, St. Borbala Hospital, St. Borbala Hospital

ClinicalTrials.gov Identifier:

NCT03716687

Other Study ID Numbers:

OGYÉI/15347-9/2018

First Posted:

Oct 23, 2018

Last Update Posted:

Mar 22, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Balázs Bánky PhD, Head of the Department of Surgery, St. Borbala Hospital, St. Borbala Hospital

negative pressure wound closure

surgical site infection

cost effectiveness

Additional relevant MeSH terms:

Surgical Wound Infection

Surgical Wound Dehiscence

Wounds and Injuries

Surgical Wound

Study Results

No Results Posted as of Mar 22, 2021