Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/02/2012
Date assigned
04/04/2012
Last edited
04/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Background and study aims
Open wounds are a major burden for the patient and lead to high healthcare costs. The aim of this study is to compare Negative Pressure Wound Therapy (NPWT) and standard wound therapy for the treatment of open abdominal wounds. NPWT involves using a sealed wound dressing connected to a vacuum pump to promote healing. We want to find out whether NPWT decreases the time it takes for the wound to close.

Who can participate?
Patients aged 18 to 85 with open abdominal wounds after surgery

What does the study involve?
Participants are randomly allocated into the intervention or control group. In the intervention group participants are treated with NPWT until wound closure, at most for 42 days. The control group receives standard wound therapy also for 42 days. After this the participants can be treated like before or with a different treatment. The following outcomes are measured: time taken for complete wound closure, number of wound closures within the 42 days of treatment, reduction of wound volume, wound infections, relapses, pain, quality of life and costs.

What are the possible benefits and risks of participating?
There are no additional risks for participants

Where is the study run from?
The study takes place country-wide at various clinical surgical departments in Germany, with a total of 25 departments/centres participating

When is the study starting and how long is it expected to run for?
February 2012 to November 2013

Who is funding the study?
Statutory Health Insurance (SHI) Germany

Who is the main contact?
Dr Tilman Treptau

Trial website

http://www.wound-care.de/ (in German)

Contact information

Type

Scientific

Primary contact

Dr Tilman Treptau

ORCID ID

Contact details

Institute for Research in Operative Medicine
University Witten/Herdecke
Ostmerheimer Straße 200 (Haus 38)
Cologne
51109
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DRKS ID 00003498

Study information

Scientific title

Randomised controlled study to evaluate the efficacy of the treatment of Iatrogenic Subcutaneous Abdominal Wounds (ISAW) after surgery, by application of Negative Pressure Wound Therapy (NPWT) in comparison to Standard Conventional Wound Therapy (SCWT) of the clinical routine

Acronym

ISAW

Study hypothesis

1. The application of NPWT for treatment of postoperative abdominal wound-healing impairments with intact fascia, results in a decrease of time until achievement of wound closure (with confirmation after 30 days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.
2. The application of NPWT represents an effective und save therapy option for the treatment of postoperative subcutaneous abdominal wound-healing impairments in inpatient and outpatient settings.

Ethics approval

University Witten/Herdecke Ethics Committee, 27/09/2011, ref: 115/2011

Study design

Multicentre randomised controlled trial

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

Iatrogenic Subcutaneous Abdominal Wounds

Intervention

Intervention group: Negative Pressure Wound Therapy (NPWT)

Control group: Standard Conventional Wound Therapy (SCWT). Methods of simple and advanced wound treatment according to the therapy recommendations.

All participants are recruited consecutively and are randomised with a computer-assisted randomisation-list. The intervention group will be treated with VAC-therapy until wound closure, at maximum for 42 days. During the time of therapy every third day changing dressing is done.

The control group will be treated and observed according to the German Association of Wound Healing and Wound Treatment also within 42 days (maximum). After the maximal duration of study treatment the participants can be treated like before or with alternative therapy. The participants of both groups will be seen after 180 days within the follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Time (number of days) to the achievement of complete wound closure (Time-to-Closure) within 42 days of treatment
2. Number of achieved wound closures within maximum therapy period (Rate-of-Closure) within 42 days of treatment

Secondary outcome measures

1. Reduction of wound volume in the course of treatment (over time)
2. Wound infections
3. Relapses
4. Pain
5. Quality of Live
6. Patient-related endpoints / Patient Reported Outcome (PRO)
7. Consumption of resources in inpatient and outpatient setting and costs (economically orientated outcome parameters)
8. Stratification according to wound volume and study centre

Overall trial start date

15/02/2012

Overall trial end date

30/11/2013

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

1. Acute subcutaneous abdominal wound-healing impairment after surgical intervention
2. Sizes of wound opening (maximum diameter ≥ 3 cm)
3. Wound depth ≥ 3 cm
4. Wound surface ≥ 9 cm2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
2. Existence of an open abdominal fascia
3. Acute serious organ failure
4. Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
5. Ongoing/during 3 weeks after chemo therapy
6. Ongoing/during 3 weeks after radiation therapy
7. Contraindications in accordance with the safety precautions issued by the FDA or the companies

Recruitment start date

15/02/2012

Recruitment end date

30/11/2013

Locations

Countries of recruitment

Germany

Trial participating centre

University Witten/Herdecke
Cologne
51109
Germany

Sponsor information

Organisation

University Witten/Herdecke (Germany)

Sponsor details

c/o Prof. h.c. Edmund A. M. Neugebauer
Chair for Surgical Research
The Institute for Research in Operative Medicine
Faculty of Health
Department of Medicine
Ostmerheimer Str. 200
Haus 38
Cologne
51109
Germany

Sponsor type

University/education

Website

http://www.uni-wh.de/

Funders

Funder type

Government

Funder name

General Insurance Fund [Allgemeine Ortskrankenkassen] (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health Insurance Association [Verband der Ersatzkassen] (Germany)

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

04/08/2016: Plain English summary added. 17/10/2013: the status of this record was changed to 'stopped' due to recruitment problems.