Condition category
Surgery
Date applied
26/03/2013
Date assigned
30/04/2013
Last edited
30/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Incisional hernia is a common and debilitating complication of abdominal surgery, with a reported incidence of between 10 and 25% of laparotomies. There is no consensus regarding the best surgical technique to treat this condition although the use of prosthesis is recommended in cases involving large hernias.
Relapse rates of 5 to 63% have been documented in patients who have undergone incisional hernia surgery, and other serious complications such as seromas, hematomas and wound infections have also been described. The development of seromas relates to fluid accumulation in the residual space of the hernia along with inflammation, disruption of lymphatics and continuous irritative effect caused by the foreign body like the prosthesis. For the prevention of postoperative seromas suction drains are placed in the subcutaneous dissection space allowing aspiration of fluid produced, along with measures of elastic compression postoperatively.
Since 1997 it has been described the use of negative pressure therapy to treat complex and open wounds. Over the years the advantages of the technique have been demonstrated, as it improves healing times by increasing blood flow, extracting secreted fluid, maintaining the wound margins and protecting the wound from contamination.
Negative pressure therapy was also later used for the treatment of closed wounds. The Prevena Incision Management System® (Kinetic Concepts Inc, San Antonio, TX, USA), which has recently appeared on the market, is specifically designed for the treatment of closed wounds and has proven effective in preventing seromas and hematomas in sternotomic and traumatologic wounds.
The Prevena Incision Management System® consists of a sponge dressing on an adhesive sheet with a suction drain with a small tank for collecting fluids. When the system is applied it holds the wound in place, isolates it from the exterior, and extracts fluids form the wound by applying negative pressure of 125 mmHg.
One study applying a conventional VAC (Vacuum Assisted Clossure) dressing as the postoperative treatment of three hernioplasties, advances the possible protective effect of negative pressure therapy in the appearance of postoperative seromas after hernioplasty. The same results were observed using the specific Prevena ® dressing in pork abdominal wounds. In our department we performed a pilot study applying negative pressure therapy by Prevena ® device to 5 patients undergoing large incisional hernia, with no postoperative complications and statistically significant reduction in postoperative drainage time required compared to a control group traditional dressing.
The objectives of this study are to assess the effectiveness of the negative pressure therapy applied on the wound of large incisional hernia surgery reducing time and subcutaneous drain debit and also in reducing postoperative complications and recurrence. Another objective is an economic analysis of the use of negative pressure therapy in these wounds.

Who can participate?
Study participants were patients from the University Hospital of Tarragona Joan XXIII who underwent elective surgery for incisional hernia with diameters exceeding 10 cm.

What does the study involve?
Patients who met the inclusion criteria, which are scheduled for incisional hernia repair of larger than 10 cm in diameter, were randomly distributed into two groups (control and NPT)
Patients in the control group were applied in the conventional postoperative compression dressing.
Patients in the NPT group, the device Prevena Incision Management System ® was immediately applied to the closed wound in the operating theatre. The dressing was left in place for seven days.
We recorded all postoperative complications, how long the drains were left in place, and any adverse reactions to the dressing. Abdominal CT scans were performed to confirm the presence or absence of post-operative seromas.

What are the possible benefits and risks of participating?
The expected benefits are decreasing the amount of drainage from the wound, reduced drainage time and hospital stay, and decreased postoperative seromas
No adverse effects have been reported from the use of negative pressure therapy in closed wounds.

Where is the study run from?
The study was conducted in the General and Digestive Surgery Department, University Hospital Joan XXIII in Tarragona, Spain

When is the study starting and how long is it expected to run for?
The study started in February 2013 and is expected to run for 12 months.

Who is funding the study?
General Surgery Department of University Hospital Joan XXIII (Spain) and Kinetic Concepts Inc, San Antonio, TX (USA) is providing the material.

Who is the main contact?
Dr Carles Olona
drcarlesolona@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carles Olona

ORCID ID

Contact details

Merce Rodoreda 11-B 2º 1ª
Tarragona
43007
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HJ23-C.1-N-12

Study information

Scientific title

Negative pressure therapy in large incisional hernia surgery: a postoperative prospective randomised controlled study

Acronym

Study hypothesis

The negative pressure therapy applied on the wound of large incisional hernia surgery reduces time and subcutaneous drain debit and also reduces postoperative complications and recurrence.

Ethics approval

The study is approved by the Scientific Committee of Clinical Research of the University Hospital Joan XXIII of Tarragona (Spain) on 04/03/2013, ref: CEIC 03/2013.

Study design

Longitudinal prospective randomised controlled case-control single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Seroma, volume and time drainage, and complications in large incisional hernia postoperative

Intervention

Patients in the control group were applied in the conventional postoperative compression dressing.

Patients in the Negative Pressure Therapy group, the device Prevena Incision Management System ® was immediately applied to the closed wound in the operating theatre. The dressing was left in place for seven days.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

The measures will be the volume accumulated in the drains every 24 hours in ml, and the number of days necessary to reduces this volume under 50ml/24h

Secondary outcome measures

1. Postoperative complications appeared as seromas, hematomas, wound infection and relapse
2. Cost analysis including the length of stay and the number o dressings changes

Overall trial start date

01/02/2013

Overall trial end date

01/02/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients operated on large incisional hernia in the Joan XXIII Hospital Surgery Department
2. Patients over 18 years
3. With incisional ring diameter over 10 cm
4. American Society of Anesthesiologists (ASA) lower than 4
5. Operated with Chevrel technique

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The target total recruitment is 26 participants for the trial, 13 for arm

Participant exclusion criteria

1. ASA grade 4
2. Patients with wound infections before surgery
3. Previous eventroplasty
4. Pregnant
5. Surgical intervention using another technique than Chevrel eventroplasty

Recruitment start date

01/02/2013

Recruitment end date

01/02/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Merce Rodoreda 11-B 2º 1ª
Tarragona
43007
Spain

Sponsor information

Organisation

University Hospital Joan XXIII de Tarragona (Spain)

Sponsor details

Dr. Mallafré Guasch 4
General and Digestive Surgery Department
Tarragona
43005
Spain

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

General Surgery Department of University Hospital Joan XXIII (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kinetic Concepts Inc, San Antonio, TX (USA) - providing the material

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes