Skin Graft ComplicationsNCT04231305
Antithrombotics and Complications in Skin Grafts
An observational study of Skin Graft Complications, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Graft Complications
- How many people
- 172 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 172 patients (92 males and 80 females) having 187 skin grafts were included. Avarage size of the skin grafts were 1278 mm2 ranging from 52mm2 to 14283mm2. Skin grafts where the patients received no or paused antithrombotic treatment were 90 while 97 skin grafts belonged to patients in antithrombotic treatment
Who may be able to join
- Patients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium -
Who cannot join
- Patients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complications in Skin Grafts When Continuing Antithrombotic Therapy Prior to Cutaneous Surgery Requiring Skin Grafting: an Observational Study
Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked
Read the detailed description
Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked
- Conditions
- Skin Graft Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative bleeding
Measured: 5-7 postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft ComplicationsStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Birk-Sørensen, Aalborg University Hospital
- Investigators
- Lene Birk-Sørensen, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231305
- Sponsor's protocol ID
- 2019-29-12
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications in Skin Grafts When Continuing Antithrombotic Therapy Prior to Cutaneous Surgery Requiring Skin Grafting: an Observational Study
- ClinicalTrials.gov ID
- NCT04231305
- Acronym / sponsor ID
- 2019-29-12
- Conditions
- Skin Graft Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jan 2020 (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.
Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked
Detailed description
Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 172 patients (92 males and 80 females) having 187 skin grafts were included. Avarage size of the skin grafts were 1278 mm2 ranging from 52mm2 to 14283mm2. Skin grafts where the patients received no or paused antithrombotic treatment were 90 while 97 skin grafts belonged to patients in antithrombotic treatment
Key inclusion criteria (1 listed)
- Patients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium -
Key exclusion criteria (2 listed)
- Patients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5
- -
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
Postoperative bleeding
Time frame: 5-7 postoperative day
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 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Lene Birk-Sørensen, PhD principal investigator
Aalborg University Hospital
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 Skin Graft Complications, run by Aalborg University Hospital at 1 site in Denmark.
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 18 Jan 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 Denmark. 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?
Postoperative bleeding (time frame: 5-7 postoperative day). 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 18 Jan 2020.