NCT01964781

Brief Summary

After surgical procedures, interventions to reduce postoperative pain and bleeding are of great importance. In this study, the effect will be investigated of smearing common drugs, which are designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. Although beneficial effects of such an easy and low-cost intervention would be expected, the investigators have found no previous reports on blinded and controlled studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

1.3 years

First QC Date

October 10, 2013

Last Update Submit

May 16, 2019

Conditions

Pain, PostoperativePostoperative Hemorrhage

Keywords

Administration, topicaltranexamic acidadrenalinebupivacainesurgery

Outcome Measures

Primary Outcomes (2)

  • Amount of blood on drains postoperatively

    Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml on the control after 24 hours.

    24 hours postoperatively

  • Amount of pain in operated breast

    Evaluate using a visual analogue scale the pain in the surgical wounds as reported by the patient 24 hours postoperatively

    Measured 24 hours postoperatively

Study Arms (6)

topical tranexamic acid

EXPERIMENTAL

tranexamic acid to be smeared on surgical wounds before closure

Drug: Tranexamic Acid

topical adrenaline

EXPERIMENTAL

adrenaline solution to be smeared on surgical wounds before closure

Drug: Adrenaline

topical bupivacaine

EXPERIMENTAL

bupivacaine to be smeared on surgical wounds before closure

Drug: Bupivacaine

topical adrenaline plus tranexamic acid

EXPERIMENTAL

tranexamic acid and adrenaline to be smeared on surgical wounds before closure

Drug: Tranexamic AcidDrug: Adrenaline

placebo control

PLACEBO COMPARATOR

saline to be smeared on surgical wounds before closure

Drug: saline

tranexamic acid and placebo control

PLACEBO COMPARATOR

tranexamic acid and saline to be smeared on surgical wounds before closure

Drug: tranexamic acid plus saline

Interventions

Tranexamic AcidDRUG

Topical administration - does it reduce surgical bleeding?

topical adrenaline plus tranexamic acidtopical tranexamic acid
BupivacaineDRUG

Topical Bupivacaine- does it reduce surgical pain?

Also known as: Marcaine
topical bupivacaine
AdrenalineDRUG

Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?

topical adrenalinetopical adrenaline plus tranexamic acid
tranexamic acid plus salineDRUG
tranexamic acid and placebo control
salineDRUG
placebo control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing unilateral simple mastectomy
  • patients undergoing bilateral symmetric breast surgery

You may not qualify if:

  • pregnancy
  • A history of former thromboembolic events (to receive TXA)
  • cardiovascular disease (to receive adrenaline)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.

    PMID: 26349843RESULT

MeSH Terms

Conditions

Pain, PostoperativePostoperative Hemorrhage

Interventions

Tranexamic AcidBupivacaineEpinephrineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsHemorrhage

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAnilidesAmidesAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hilde Pleym, MD PhD

    St. Olavs Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2013

First Posted

October 17, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)