Soft Tissue SarcomaNCT03900078
Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors
A study testing Incisional negative pressure wound therapy and Wound dressing with adhesive tapes in people with Soft Tissue Sarcoma and Lipoma, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Lipoma, Tumor
- What is being tested?
- Incisional negative pressure wound therapy and Wound dressing with adhesive tapes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 15 Sep 2020
- 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
- Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
Who cannot join
- No primary skin closure.
- Skin infection in area of operation (e.g. acne inversa).
Trial locations and contacts
1 site in 1 country.
Germany1 site
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, North Rhine-Westphalia, 44789
About this study
Official title: Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.
Read the detailed description
Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.
- Conditions
- Soft Tissue Sarcoma, Lipoma, Tumor
- Being tested
- Incisional negative pressure wound therapy, Wound dressing with adhesive tapes
- Medical subject headings
- Sarcoma, Lipoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional negative pressure wound therapyOther
A negative pressure dressing is applied to the skin incision.
Wound dressing with adhesive tapesOther
Regular adhesive wound tapes are applied over the closed skin.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes. Receives: Other: Wound dressing with adhesive tapes |
| Incisional negative pressure group | Experimental | After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days. Receives: Other: Incisional negative pressure wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of drainage fluid
Measurement of total fluid amounts in drains and negative pressure device
Measured: up to 14 days postoperatively
Secondary outcomes (2)
Wound complications
Assessment of course of wound healing, necessary operative revisions, seroma formation
Measured: 3 months
Wound margin perfusion
Measurement with laser doppler
Measured: 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Dec 2018
- Primary completion1 Aug 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies 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
- Model description
- RCT with two therapy arms.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehran Dadras, MD, Ruhr University of Bochum
- Investigators
- Björn Behr, MD, Principal investigator, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil BochumMehran Dadras, MD, Study director, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900078
- Sponsor's protocol ID
- 18-6411-BR
- Status last verified
- Oct 2020
- First submitted
- 26 Mar 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
- ClinicalTrials.gov ID
- NCT03900078
- Acronym / sponsor ID
- 18-6411-BR
- Conditions
- Soft Tissue Sarcoma, Lipoma, Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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.
This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.
Detailed description
Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with two therapy arms.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Wound dressing with adhesive tapesAfter subcuticular skin suture, patients receive standard dressing with adhesive wound tapes. |
| Incisional negative pressure group | Experimental | Other: Incisional negative pressure wound therapyAfter subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
Key exclusion criteria (2 listed)
- No primary skin closure.
- Skin infection in area of operation (e.g. acne inversa).
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 |
|---|---|---|
| Incisional negative pressure wound therapyA negative pressure dressing is applied to the skin incision. | Other | Incisional negative pressure group |
| Wound dressing with adhesive tapesRegular adhesive wound tapes are applied over the closed skin. | Other | Control group |
Primary outcome
Amount of drainage fluid
Time frame: up to 14 days postoperatively
Measurement of total fluid amounts in drains and negative pressure device
2 secondary outcomes
Wound complications
Time frame: 3 months
Wound margin perfusion
Time frame: 5 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Björn Behr, MD principal investigator
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Mehran Dadras, MD study director
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional negative pressure wound therapy and Wound dressing with adhesive tapes in people with Soft Tissue Sarcoma and Lipoma, run by Ruhr University of Bochum at 1 site 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of drainage fluid (time frame: up to 14 days postoperatively). 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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.