Postoperative Abdominal WoundsISAWNCT01611207
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
A study testing Negative Pressure Wound Therapy and Standard Wound Therapy in people with Postoperative Abdominal Wounds and Wound-healing Impairments, run by University of Witten/Herdecke at 34 sites in Germany.
Trial summary
The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Abdominal Wounds, Wound-healing Impairments
- What is being tested?
- Negative Pressure Wound Therapy and Standard Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 34 sitesGermany
- Study dates
- Jun 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute subcutaneous abdominal wound-healing impairment after surgical intervention
- Sizes of wound opening (maximum diameter ≥ 3 cm)
- Wound surface ≥ 9 qcm
Who cannot join
- Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
- Existence of an open abdominal fascia
- Acute serious organ failure
- Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
- Ongoing / during 3 weeks after chemo therapy
- Ongoing / during 3 weeks after radiation therapy Contraindications in accordance with the safety precautions issued by the FDA or the companies
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Germany34 sites
St. Marien-Krankenhaus Ahaus-Vrede
Ahaus, 48683
Asklepios Stadtklinik Bad Tölz GmbH
Bad Tölz, 83646
Bundeswehrkrankenhaus Berlin
Berlin, 10115
Klinikum Bilefeld - Mitte
Bielefeld, 33604
Knappschaftskrankenhaus Bochum der Ruhr
Bochum, 44892
Klinikum Darmstadt, Chirurgische Klinik III
Darmstadt, 64283
Diakonissenkrankenhaus Dessau /Roßlau
Dessau, 06846
Krankenhaus Düren gem. GmbH
Düren, 52351
Klinik für Gefäß- und Endovascular-Chirurgie, Klinikum der Johann Wolfgang Goethe - Universität
Frankfurt am Main, 81377
Krankenhaus Martha-Maria Halle-Dölau
Halle, Saxony-Anhalt, 06120
Krankenhaus St. Elisabeth und St. Barbara, Klinik für Allgmein- und Visceralchirurgie
Halle, 06110
Universitätsklinikum Halle/Saale, Allgemein-, Viszeral- und Gefäßchirurgie
Halle, 06120
Asklepios Westklinikum Hamburg
Hamburg, 22559
Sana Klinikum Hameln-Pyrmont Klinik für Allgemein- und Visceralchirurgie
Hamelin, 31785
Gemeinschaftskrankenhaus Herdecke
Herdecke, 58313
Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
Jena, 07743
Universitätsklinikum Jena, Klinik für Frauenheilkunde und Geburtshilfe, Abt. Gynäkologie
Jena, 07743
Westpfalz-Klinikum GmbH, Klinikum für Allgemein-, Viszeral- und Transplantationschirurgie
Kaiserslautern, 67655
Städtisches Klinikum Karlsruhe gGmbH, Klinik für Allgemein- und Viszeralchirurgie
Karlsruhe, 76133
Kliniken der Stadt Köln Krankenhaus Merheim, Klinik für Visceral-, Gefäß- und Transplantationschirurgie
Köln-Merheim, 51109
Universitätsklinikum Schleswig-Holstein, Klinik für Chirurgie
Lübeck, 23538
Klinik und Poliklinik für Allgemein- und Abdominalchirurgie, Johannes Gutenberg- Universität
Mainz, 55131
Wundzentrum München
München, 81927
Klinikum der Universität München, Chirurgische Klinik und Poliklinik
München-Großhadern, 81377
Universitätsklinikum Münster, Klinik für Allgemein und Viszeralchirurgie
Münster, 48149
Städtisches Klinikum Neunkirchen
Neunkirchen/Saar, 66538
Ortenauklinikum Offenburg-Gengenbach
Offenburg, 77654
Klinikum Dorothea Christiane Erxleben
Quedlinburg
Carl-von-Basedow Klinikum, Saalekreis
Querfurt, 06268
Zentrum für Gefäßmedizin Klinikum Südstadt Rostock
Rostock, 18059
Asklepios Klinikum Uckermark GmbH, Klinik für Allgemein- und Visceralchirurgie
Schwedt, 16303
Agaplesion Bethesda-Krankenhaus Stuttgart
Stuttgart, 70184
HSK Dr. Horst Schmidt Kliniken
Wiesbaden, 65195
Evangelisches Krankenhaus Paul Gerhardt Stift, Allgemein-, Viszeral- und Gefäßchirurgie
Wittenberg, 06886
About this study
Official 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.
The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW).
Read the detailed description
The aim of the study is the comparison between NPWT and Standard Conventional Wound Therapy (SCWT) under clinical, safety and economic aspects in the treatment of postoperative Iatrogenic Subcutaneous Abdominal Wounds (ISAW). The hypothesis is based on the assumption that the application of NPWT for the 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 consecutive days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.
- Being tested
- Negative Pressure Wound Therapy, Standard Wound Therapy
- Keywords
- wound healing impairments,, negative pressure wound therapy,, health services research,, germany
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called Vacuum assisted closure, Vacuum assisted wound closure
KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith \& Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations.
Standard Wound TherapyOther
Also called Standard Conventional Wound Therapy
Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Used therapy systems Receives: Device: Negative Pressure Wound Therapy |
| Standard Conventional Wound Therapy | Active comparator | Standard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment) Receives: Other: Standard Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure
Time-of-closure (in days) achieved and confirmed wound closures and rate-of-closure (in number). The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material.
The closure must remain at least for a period of 30 days.
Measured: within 42 days of treatment
Secondary outcomes (9)
Wound volume
Reduction of wound volume (cubic centimeter) in the course of treatment.
Measured: within the observation period of 180 days
Wound infections
Number of wound infections over the time.
Measured: within the observation period of 180 days
Recurrences
Number of recurrences over the time.
Measured: wthin observation period of 180 days
Pain
Measured: within a maximum treatment time of 42 days
Quality of Life
EQ-5D at inclusion, end of maximum treatment time or end of therapy, Follow-Up after 180 days.
Measured: within observation period of 180 days
Direct costs
direct medical resource use and costs: hospitalization, outpatient contact with study centre and other providers, reimbursable drugs, medical sundries, adjuvants, reimbursable services direct non-medical resource use and costs: services, travel costs, expenditure of time for patients, expenditure of time for lay care
Measured: within a maximum treatment time of 42 days or until end of therapy
Indirect costs
Disability, disability pension, premature death
Measured: within a maximum treatment time of 42 days or until end of therapy
Serious adverse events
Measured: within the observation period of 180 days
Adverse events
Wound- and device-specific adverse events
Measured: within a maximum treatment time of 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: The patient recruitment was behind target, no successful completion of the planned patient numbers within trial period could be expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Abdominal WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc
- Responsible party
- Principal investigator, Dr. Marcus Redaèlli, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611207
- Sponsor's protocol ID
- 03-2012
- Other IDs
- DRKS ID 00003498
- Acronym
- ISAW
- Status last verified
- May 2013
- First submitted
- 28 Mar 2012
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01611207
- Acronym / sponsor ID
- ISAW / 03-2012
- Keywords
- wound healing impairments,, negative pressure wound therapy,, health services research,, germany
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The patient recruitment was behind target, no successful completion of the planned patient numbers within trial period could be expected
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc., Smith & Nephew Wound Management Inc
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Negative Pressure Wound Therapy (NPWT) or Standard Conventional Wound Therapy (SCWT) are effective in the treatment of Iatrogenic Subcutaneous Abdominal Wound healing-impairments (ISAW).
Detailed description
The aim of the study is the comparison between NPWT and Standard Conventional Wound Therapy (SCWT) under clinical, safety and economic aspects in the treatment of postoperative Iatrogenic Subcutaneous Abdominal Wounds (ISAW). The hypothesis is based on the assumption that the application of NPWT for the 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 consecutive days) and for this reason more wound closures can be achieved in the maximum treatment period of 42 days compared to the control therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyUsed therapy systems |
| Standard Conventional Wound Therapy | Active comparator | Other: Standard Wound TherapyStandard conventional wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute subcutaneous abdominal wound-healing impairment after surgical intervention
- Sizes of wound opening (maximum diameter ≥ 3 cm)
- Wound surface ≥ 9 qcm
Key exclusion criteria (6 listed)
- Lack of infrastructure for outpatient continuation of treatment and study-specific interventions
- Existence of an open abdominal fascia
- Acute serious organ failure
- Application of an other active vacuum device at the wound treated during the study conduct within 8 days before screening visit
- Ongoing / during 3 weeks after chemo therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyAlso: Vacuum assisted closure, Vacuum assisted wound closureKCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith \& Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations. | Device | Negative Pressure Wound Therapy |
| Standard Wound TherapyAlso: Standard Conventional Wound TherapyStandard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment) | Other | Standard Conventional Wound Therapy |
Primary outcome
Wound closure
Time frame: within 42 days of treatment
Time-of-closure (in days) achieved and confirmed wound closures and rate-of-closure (in number). The wound closure is defined as 100% epithelialization; no need for drainage, no need for supportive therapy or a means of assistance and absence of suture material. The closure must remain at least for a period of 30 days.
9 secondary outcomes
Wound volume
Time frame: within the observation period of 180 days
Wound infections
Time frame: within the observation period of 180 days
Recurrences
Time frame: wthin observation period of 180 days
Pain
Time frame: within a maximum treatment time of 42 days
Quality of Life
Time frame: within observation period of 180 days
Direct costs
Time frame: within a maximum treatment time of 42 days or until end of therapy
Indirect costs
Time frame: within a maximum treatment time of 42 days or until end of therapy
Serious adverse events
Time frame: within the observation period of 180 days
Adverse events
Time frame: within a maximum treatment time of 42 days
Results and safety
The study was stopped early (reason given: The patient recruitment was behind target, no successful completion of the planned patient numbers within trial period could be expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Standard Wound Therapy in people with Postoperative Abdominal Wounds and Wound-healing Impairments, run by University of Witten/Herdecke at 34 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The patient recruitment was behind target, no successful completion of the planned patient numbers within trial period could be expected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure (time frame: within 42 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.