Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery

Ausen, Kjersti; Pleym, Hilde; Liu, Jiayin; Hegstad, Solfrid; Nordgård, Håvard Bersås; Pavlović, Ivan; Spigset, Olav

doi:10.1097/prs.0000000000005620

Cited by 46 publications

(35 citation statements)

References 63 publications

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“…As topical use is off‐label and the possible local effects of prolonged tissue exposure are largely unknown, keeping drug concentration and contact time as low as possible would be a sensible precaution when advocating routine prophylactic use. Although bolus and gauze administrations may lead to prolonged exposure to TXA, the authors' previous study demonstrated that topical moistening has predictable and swift elimination, as well as rendering systemic concentrations negligible.…”

Section: Discussionmentioning

confidence: 99%

“…The present authors have previously introduced a novel procedure in which the wound surface is simply moistened with 25 mg/ml tranexamic acid before closure, with a mean 39 per cent reduction in drain volume in a small proof‐of‐concept, randomized, placebo‐controlled study of bilateral reduction mammoplasty. Such moistening exposes the wound surface to TXA for a considerably shorter time than topical boluses.…”

Section: Introductionmentioning

confidence: 99%

“…Although minimization of blood loss is desirable in all operations, general use of intravenous TXA has not been advocated owing to unease regarding possible systemic adverse effects 8,9 . A prophylactic intervention to minimize postoperative blood loss should be low-cost, simple, efficient and safe. Topical use of TXA may provide a high drug concentration on the wound surface with negligible systemic concentrations 10 . Topical use is still off-label, with no consensus regarding the optimal TXA concentration in the solution applied, mode of application or duration of contact 11,12 .…”

Section: Introductionmentioning

confidence: 99%

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Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial

et al. 2019

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Background Topical administration of tranexamic acid (TXA) may be an alternative to intravenous administration to reduce bleeding with a lower risk of systemic adverse events. The aim of this study was to investigate whether moistening a surgical wound with TXA before closure, leaving a thin film of drug only, would reduce postoperative bleeding. Methods This was a two‐centre, stratified, parallel‐group, placebo‐controlled, double‐blind RCT. Patients undergoing mastectomy with or without axillary lymph node clearance were randomized 1 : 1 to moistening of wound surface before closure with either 25 mg/ml TXA or 0·9 per cent sodium chloride (placebo). The primary endpoint was postoperative bleeding as measured by drain production in the first 24 h. Secondary endpoints were early haematoma, total drain production, postoperative complications and late aspirations of seroma within 3 months. Results Between 1 January 2016 and 31 August 2018, 208 patients were randomized. Two patients were converted to a different surgical procedure at surgery, and four did not receive the intervention owing to technical error. Thus, 202 patients were included in the study (101 in the TXA and 101 in the placebo group). TXA reduced mean drain production at 24 h (110 versus 144 ml; mean difference 34 (95 per cent c.i. 8 to 60) ml, P = 0·011). One patient in the TXA group had early haematoma compared with seven in the placebo group (odds ratio (OR) 0·13 (95 per cent c.i. 0·02 to 1·07); P = 0·057). There was no significant difference in postoperative complications between TXA and placebo (13 versus 10; OR 1·11 (0·45 to 2·73), P = 0·824) or need for late seroma aspirations (79 versus 67 per cent; OR 1·83 (0·91 to 3·68), P = 0·089). Conclusion Moistening the wound with TXA 25 mg/ml before closure reduces postoperative bleeding within the first 24 h in patients undergoing mastectomy. Registration number: NCT02627560 (https://clinicaltrials.gov).

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial

et al. 2019

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“…The topically applied concentration will be diluted by local tissue fluids and the drug will be absorbed gradually. A moistening film will be diluted and absorbed rapidly, representing a limited exposure, whereas a bolus administration into a closed wound cavity will be diluted more slowly and may remain in contact with the wound surface for much longer, representing a chronic exposure.…”

Section: Methodsmentioning

confidence: 99%

“…Topical administration of TXA provides a high concentration at the application site where the antifibrinolytic effect is needed, but a low systemic concentration with an assumed reduced risk of systemic side‐effects. Studies on topical use have been published, particularly from orthopaedic and cardiothoracic surgery, and experience of use in other surgical specialties is increasingly emerging.…”

Section: Introductionmentioning

confidence: 99%

Cytotoxicity and effect on wound re‐epithelialization after topical administration of tranexamic acid

et al. 2019

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BackgroundTopical administration of tranexamic acid (TXA) reduces bleeding from surgical wounds similarly to intravenous use, but with negligible risk of adverse systemic events. Topical use is expanding, but is off‐label. Surgeons lack guidelines regarding safe topical dosages and modes of administration. The effects of topical TXA on skin cells and wound healing are unknown. This study investigated whether topical TXA might be cytotoxic or affect wound re‐epithelialization.MethodsHuman keratinocytes and fibroblast cell cultures and an ex vivo human skin wound model were subjected to both short (limited) and long (chronic) exposure to various clinically relevant concentrations of TXA to mimic different modalities of topical administration. Cytotoxicity and effects on wound re‐epithelialization were evaluated.ResultsIn cell culture, toxicity from chronic exposure was associated with increasing concentration and exposure time. Limited exposure to TXA did not cause significant cytotoxicity even at high concentrations. Re‐epithelialization was completely absent in wounds chronically exposed to TXA concentrations of 25 mg/ml or above, and 50–100 mg/ml induced epidermolysis of normal epithelium, possibly by a non‐toxic mechanism. Wound re‐epithelialization was slightly delayed, but not impaired, by limited exposure to 100 mg/ml or chronic exposure to 6·25 mg/ml.ConclusionAlthough short exposure to even high concentrations of topical TXA seems well tolerated in vitro, prolonged exposure can be cytotoxic and may affect wound re‐epithelialization. Surgeons should adjust the TXA concentration to the planned mode of topical administration in clinical practice. Surgical relevanceTopical tranexamic acid (TXA) may reduce bleeding from surgical wounds similarly to intravenous administration without the risk of systemic effects. Little is known, however, regarding the adverse effects of TXA on exposed tissues.We exposed in vitro human keratinocytes and fibroblasts and an ex vivo human skin wound model to TXA at various concentrations and time intervals and found that short exposure to even high concentrations or prolonged exposure to low concentrations of TXA was well tolerated. Prolonged exposure to increasing concentrations increased keratinocyte and fibroblast toxicity, and TXA concentrations of 25 mg/ml or above completely prevented wound‐re‐epithelialization.Prolonged exposure to high concentrations of topical TXA may exert unwanted local tissue effects. This study suggests that surgeons should adjust TXA concentration to the planned mode of topical administration in clinical practice.

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Tranexamic acid in endoscopic sinus and skull base surgery: A systematic review and meta‐analysis

Abdallah

Staibano

Zhou

et al. 2023

Int Forum Allergy Rhinol

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ObjectiveEndoscopic sinus surgery (ESS) and endoscopic skull base surgery (ESBS) approaches have revolutionized the management of sinonasal and intracranial pathology. Maintaining surgical hemostasis is essential as bleeding can obscure the visibility of the surgical field, thus increasing surgical duration, risk of complications, and procedural failure. Tranexamic acid (TXA) acts to reduce bleeding by inhibiting fibrin degradation. This review aims to assess whether TXA improves surgical field quality and reduces intraoperative blood loss compared with control.MethodsWe searched PubMed, MEDLINE, Embase, Web of Science, and Cochrane Library from inception until September 1, 2022. Two reviewers independently screened citations, extracted data, and assessed methodological quality using the Cochrane risk‐of‐bias tool for randomized trials. Data were pooled using a random‐effect model, with continuous data presented as mean differences and dichotomous data presented as odds ratios.ResultsSeventeen ESS randomized controlled trials (n = 1377) and one ESBS randomized controlled trial (n = 50) were reviewed. Significant improvement in surgical field quality was achieved with both systemic TXA (six studies, p < 0.00001) and topical TXA (six studies, p = 0.01) compared with the control. Systemic TXA (eight studies) and topical TXA (three studies) both achieved a significant reduction in intraoperative blood loss compared with the control (p < 0.00001). There were significant differences in operative times (p < 0.001) but no significant difference in perioperative outcomes (p = 0.30).ConclusionThis meta‐analysis demonstrated that the administration of TXA in ESS can improve surgical field quality and reduce intraoperative blood loss. TXA use did not result in increased perioperative complications including thrombotic events.

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Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery

Abstract: Supplemental Digital Content is available in the text.

Cited by 46 publications

References 63 publications

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial

Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial

Cytotoxicity and effect on wound re‐epithelialization after topical administration of tranexamic acid

Tranexamic acid in endoscopic sinus and skull base surgery: A systematic review and meta‐analysis

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