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The effect of a 3D Device compared to Elastic Bandages in controlling Swelling after Facial Surgery

Efficacy of a Personalized Rigid Device compared to Adhesive Tapes in controlling Edema in the postoperative period of Trauma Surgeries in Oral and Maxillofacial Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5xcszv2
Enrollment
Unknown
Registered
2023-10-25
Start date
2023-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillofacial Injuries

Interventions

This is a randomized controlled clinical trial based on the use of specific online randomization software (www.sorteador.com.br) prior to the proposed procedure. Blinding will not be possible in this
J01.897.564
E07.101.036

Sponsors

Universidade de Pernambuco - Departamento de Cirurgia e Traumatologia Buco-Maxilo-Facial
Lead Sponsor
Núcleo de Tecnologias Estratégicas em Saúde (NUTES)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients under the care of the Oral and Maxillofacial Surgery and Traumatology specialty at the Campina Grande Trauma Hospital, aged 18 years or older, regardless of gender, with unilateral and isolated zygomatic fractures classified as type III, IV, and V according to Knight and North's classification (1961), and treated by the same operator (surgeon) during the same surgical procedure

Exclusion criteria

Exclusion criteria: Presence of neurological deficit after the trauma episode; history of surgery in the facial region prior to the current trauma; systemic disease without clinical control; continuous drug therapy for special patients, with coagulopathies, rheumatic and autoimmune diseases; chronic use of nicotine, alcohol or drugs; trans or postoperative complications; sensitivity/allergy to elastic tape or any component that makes up the personalized rigid device; deny participation in the study and do not sign the informed consent form

Design outcomes

Primary

MeasureTime frame
It is expected to prove that both intervention methods are considered valid in controlling edema, believing that the prototyped device can be a new tool in controlling post-surgical edema in oral and maxillofacial surgeries, as well as elastic bandages. which are already widely used for this purpose.—

Secondary

MeasureTime frame
It is expected to prove that both methods are considered valid in controlling trismus and pain, believing that the prototyped device can be a new tool in post-surgical morbidity in oral and maxillofacial surgeries, as well as elastic bandages.—

Countries

Brazil

Contacts

Public ContactRebeca Pereira

Universidade de Pernambuco - Departamento de Cirurgia e Traumatologia Buco-Maxilo-Facial

rebeca.valeska@upe.br+55(83)988004479

Outcome results

None listed

Source: REBEC (via WHO ICTRP)