Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270407
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-13
Brief Title:
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
Sponsor:
St Olavs Hospital
Organization:
St Olavs Hospital
Study Overview
Official Title:
The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery a Multicenter Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANOP
Brief Summary:
Study objective
This is a study to investigate whether applying the drug tranexamic acid TXA onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention wound complications such as infection wound rupture or seroma or if it may increase the risk of blood clots
Eligible patients
Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery
Study intervention
Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery Study drug will be identical looking ampoules which contain either TXA or placebo saline Neither participants nor study personnel will know the contents of the ampoules
This is a study to investigate whether applying the drug tranexamic acid TXA onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention wound complications such as infection wound rupture or seroma or if it may increase the risk of blood clots
Eligible patients
Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery
Study intervention
Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery Study drug will be identical looking ampoules which contain either TXA or placebo saline Neither participants nor study personnel will know the contents of the ampoules
Detailed Description:
Any serious postoperative complication needing intervention specifically re-bleeding wound infection wound rupture or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions
Screening of patient medical records
Distribution of an electronic self-report form eForsk to participating patients at postoperative day 30
Follow-up phone call to verify data after day 30
The study is terminated after the final phone call All study data will be registered in an electronic pseudonymous web-based registration form eCRFViedoc
Number of participants To assess the effect of TXA on the defined surgical complications compared to placebo 1500 patients are needed in each group
Data monitoring committee
A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention
Screening of patient medical records
Distribution of an electronic self-report form eForsk to participating patients at postoperative day 30
Follow-up phone call to verify data after day 30
The study is terminated after the final phone call All study data will be registered in an electronic pseudonymous web-based registration form eCRFViedoc
Number of participants To assess the effect of TXA on the defined surgical complications compared to placebo 1500 patients are needed in each group
Data monitoring committee
A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001580-28 | EUDRACT_NUMBER | None | None |
| 2023-510381-28-00 | REGISTRY | CTIS European Clinical Trial Identification System | None |