Impaired Wound HealingINWOUNDNCT00735579
Wound Healing Abnormalities in Major Abdominal Surgery
An observational study of Impaired Wound Healing and Factor XIII Deficiency, run by Klinikum St. Georg gGmbH at 1 site in Germany.
Trial summary
This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Impaired Wound Healing, Factor XIII Deficiency
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to 21 Apr 2017
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing major abdominal surgery
Who may be able to join
- Age >= 18 years
- Male or female
- Informed consent
- Major abdominal surgery
Who cannot join
- Pre-existing coagulation abnormalities
- Pre-existing severe renal or liver failure
- Chemo- or radiochemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation
This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.
- Conditions
- Impaired Wound Healing, Factor XIII Deficiency
- Keywords
- major abdominal surgery, coagulation, extracellular matrix proteins, wound healing after major abdominal surgery
- Medical subject headings
- Factor XIII Deficiency, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing major abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound healing abnormalities
Occurence of wound healing abnormalities within the first 28 days after surgery
Measured: from baseline to postoperative day 28
Secondary outcomes (1)
Abnormalities in coagulation parameters
occurence of low platelets (<60.000) or factor XIII < 50% between the first and seventh postoperative day
Measured: postoperative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startJul 2008
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Wound HealingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum St. Georg gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Sablotzki, MD, Klinikum St. Georg gGmbH
- Investigators
- Armin R Sablotzki, MD, Principal investigator, Klinikum St. Georg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735579
- Sponsor's protocol ID
- EK-BR-21/08-1
- Other IDs
- Stu08/0022
- Acronym
- INWOUND
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2008
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation
- ClinicalTrials.gov ID
- NCT00735579
- Acronym / sponsor ID
- INWOUND / EK-BR-21/08-1
- Conditions
- Impaired Wound Healing, Factor XIII Deficiency
- Keywords
- major abdominal surgery, coagulation, extracellular matrix proteins, wound healing after major abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Klinikum St. Georg gGmbHUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 15 Aug 2008 (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.
This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients undergoing major abdominal surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing major abdominal surgery
Key inclusion criteria (4 listed)
- Age >= 18 years
- Male or female
- Informed consent
- Major abdominal surgery
Key exclusion criteria (3 listed)
- Pre-existing coagulation abnormalities
- Pre-existing severe renal or liver failure
- Chemo- or radiochemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of wound healing abnormalities
Time frame: from baseline to postoperative day 28
Occurence of wound healing abnormalities within the first 28 days after surgery
1 secondary outcome
Abnormalities in coagulation parameters
Time frame: postoperative day 28
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 24 Apr 2017.
- Related InfoLink provided by the sponsor.
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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.
Armin R Sablotzki, MD principal investigator
Klinikum St. Georg gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Wound Healing and Factor XIII Deficiency, run by Klinikum St. Georg gGmbH 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 4 inclusion and 3 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 24 Apr 2017. 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?
Incidence of wound healing abnormalities (time frame: from baseline to postoperative day 28). 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 24 Apr 2017.