Investigating tranexamic acid for bleeding control in facelift surgery

ISRCTN	ISRCTN17892023
DOI	https://doi.org/10.1186/ISRCTN17892023
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	E-23-8441
Sponsor	King Saud University
Funder	Investigator initiated and funded

Submission date: 01/11/2025
Registration date: 06/11/2025
Last edited: 06/11/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This randomized controlled trial investigates whether local tranexamic acid (TXA) can reduce intraoperative bleeding and postoperative complications (like hematoma, swelling, and bruising) in patients undergoing facelift (rhytidectomy) surgery at King Abdulaziz University Hospital. TXA is known for minimizing bleeding in surgery, but no RCT has evaluated its local use in facelifts.

Who can participate?
Healthy adults aged 35 years and older, or those with stable (compensated) medical conditions, who are undergoing facelift surgery.
People are excluded if they are under 35, have bleeding or clotting disorders, take anticoagulants or hormones, or have major organ failure.

What does the study involve?
Participants are randomly assigned to either:
Intervention group: receive local TXA under the skin flap, or
Control group: receive standard care (lidocaine with epinephrine only).
Bleeding is measured during surgery, and participants attend three follow-up visits (days 1, 6, and 9) and one remote check. Surgeons and patients rate bruising and swelling at each visit.

What are the possible benefits and risks of participating?
Benefits: TXA may reduce bleeding, bruising, swelling, and overall complications, leading to faster recovery.
Risks: Rare allergic or clotting reactions, nausea, low blood pressure, rash, or visual disturbances. Pregnant or breastfeeding individuals must not participate.

Where is the study run from?
Conducted at King Abdulaziz University Hospital (KAUH), Riyadh, Saudi Arabia, under King Saud University supervision.

When is the study starting and how long is it expected to run for?
February 2024 to June 2026

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Principal Investigator:
Prof. Ahmad Al-Arfaj, aalarrfaj@ksu.edu.sa

Contact information

Dr Abdulaziz AlEnazi
Scientific

SB-ORLHNS, EBEORL-HNS, ABHS-ORLHNS, JMC-ORL,DOHNS
Otolaryngology Head Neck & Facial Plastic Surgery
Imam Abdulrahman Bin Faisal University.
Al Khobar
34212
Saudi Arabia

ORCID ID	0000-0002-0270-1906
Email	asenazi@iau.edu.sa

Prof Ahmed Alarfaj
Principal investigator

Facial Plastic Unit
King Saud University, Riyadh KAUH, ENT Department
KSU Facial Plastic Fellowship
Riyadh
12629
Saudi Arabia

ORCID ID	0009-0009-5436-3660
Email	aalarrfaj@ksu.edu.sa

Dr Abdulaziz Alderaywsh
Public

Family and Community Medicine King Saud University
Riyadh
12372
Saudi Arabia

ORCID ID	0000-0001-7327-5708
Email	aalderaywsh@ksu.edu.sa

Study information

Primary study design	Interventional
Study design	Interventional single blind randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of local tranexamic acid on bleeding during rhytidectomy and post operative complication: randomized, controlled, single-blind trial
Study acronym	TXA-Rhytid Trial
Study objectives	Determine whether Local TXA has any effect on intraoperative bleeding or postoperative sequelae in patients undergoing a facelift.
Ethics approval(s)	Approved 19/02/2024, College of Medicine Institutional Review Board (King Saud University – College of Medicine, Riyadh, 11472, Saudi Arabia; +966 114670011; irbresearch2@gmail.com), ref: E-23-8441
Health condition(s) or problem(s) studied	Prevention of bleeding and postoperative complication in Rhytidectomy
Intervention	Control: Tumescent ( 0.5% lidocaine with 1:200,000 epinephrine). Case: Tranexamic acid (TXA) +Tumescent ( 1 mg/ml TXA and 0.5% lidocaine with 1:200,000 epinephrine) Administration Rout: Local Infiltration Randomization of allocation: by using random numbers table generated in the Statistical Package for Social Studies (SPSS v. 21) (SPSS v. 21, IBM Corp., New York, NY, USA) The total duration of treatment and follow-up will be 1 month
Intervention type	Drug
Phase	Phase III/IV
Drug / device / biological / vaccine name(s)	Tranexamic acid
Primary outcome measure(s)	Certainly, Nicholas. Here's the revised list of outcome measures in the correct format: 1. Intraoperative blood loss is measured using the volume collected in the surgical suction container during surgery 2. Intraoperative blood loss is measured using gravimetric analysis by weighing surgical sponges and gauze before and after use during surgery 3. Postoperative edema is measured using a subjective 3-point scale (mild, moderate, severe) assessed by both patient and surgeon at postoperative visits 1, 6, and 9 4. Postoperative ecchymosis is measured using a subjective 3-point scale (mild, moderate, severe) assessed by both patient and surgeon at postoperative visits 1, 6, and 9 5. Postoperative edema is measured using objective volumetric assessment with Vectra imaging at postoperative visits 1, 6, and 9 6. Postoperative ecchymosis is measured using objective volumetric assessment with Vectra imaging at postoperative visits 1, 6, and 9
Key secondary outcome measure(s)	1. Patient satisfaction is measured using the FACE-Q questionnaire at baseline (before procedure) and postoperative day 9 2. Time to drain removal is measured using clinical records at end of study 3. Complications will be assessed at follow up visits: - Skin necrosis - Hematoma - Thromboembolic events - Infection
Completion date	01/06/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	35 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	32
Key inclusion criteria	1. ≥ 35-year-old 2. Capable for follow up 3. Healthy patients or with compensated comorbidities, after the agreement of the assigned health care team 4. Candidates for cosmetic face and neck surgery 5. Absence of previous surgeries on the face
Key exclusion criteria	1. < 35-year-old 2. History of thromboembolic events or seizure 3. History of bleeding disorder 4. Active use of oral contraceptive pills and/or hormone replacement therapy, Aspirin, anti-coagulant, and Omega 3 5. Patient preference 6. Any condition increase edema (Renal failure, heart failure, liver disease)
Date of first enrolment	01/05/2024
Date of final enrolment	01/05/2026

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

King Abdulaziz University Hospital, King Saud University

King Abdulaziz Rd, Al Malaz
Riyadh
12629
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/11/2025: Trial's existence confirmed by College of Medicine Institutional Review Board King Saud University.