Effect of Redon-type Drains on Postoperative Edema Following Mandibular Orthognathic Surgery: a Randomized, Controlled Superiority Trial With Two Parallel Arms (DPO - OM)

November 11, 2026 updated by: University Hospital, Tours

Orthognathic surgery involves the maxillary and/or mandibular skeletal bases; it entails maxillary and/or mandibular osteotomies (such as sagittal split osteotomies of the mandibular rami) aimed at restoring normal maxillomandibular skeletal and dento-occlusal relationships in patients with maxillomandibular dysmorphosis. These deformities give rise to morphological, aesthetic, and functional abnormalities that can be severe (e.g., respiratory issues, temporomandibular joint pain). Postoperative edema is inevitable following orthognathic surgery; it can be significant, causing pain and discomfort while delaying patient recovery and hospital discharge. The use of Redon-type drains for mandibular osteotomies is not a standard practice across surgical teams due to a lack of consensus. The only available data come from studies with methodologies that do not allow for a definitive conclusion regarding the superiority of using-or not using-postoperative Redon drains (Lee et al. 2020), and no clinical trials have investigated this issue. This project aims to evaluate the impact of Redon-type drainage in mandibular osteotomies (sagittal split osteotomies of the mandibular rami), whether or not combined with genioplasty (osteotomy of the mental symphysis). We hypothesize that drainage using Redon-type drains for 6 hours in the immediate postoperative period following mandibular osteotomies significantly reduces postoperative edema.

The primary objective of this clinical trial is to demonstrate the superiority-in terms of reducing postoperative edema at day 2-of placing Redon-type drains for 6 hours immediately following sagittal split osteotomy of the mandibular rami (in addition to standard postoperative care) compared to standard postoperative care alone, without a drainage device.

Hypothesis: Demonstrating that the use of Redon-type drains following orthognathic surgery osteotomies reduces postoperative edema, pain, and discomfort would provide a rational basis for this practice and support its routine implementation. The expected benefits are twofold, impacting both patients and public health. For patients, the anticipated benefits include reduced postoperative discomfort and pain, faster recovery, and shorter hospital stays, with the future prospect of outpatient care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Angers, France
        • Chu Angers
      • Nantes, France
        • Chu Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients aged 15 years or older

  • Undergoing mandibular osteotomies, with or without genioplasty, with or without wisdom tooth extraction (maxillary and/or mandibular)

  • Informed consent obtained from the adult patient, or from the holder(s) of parental authority if the patient is a minor*

  • Enrolled in a French social security program

    • When both holders of parental authority cannot give joint consent, the consent of a single legal representative may be obtained in situations provided for by regulations or duly justified and documented in the source file.

Exclusion Criteria:

  • History of maxillomandibular bone surgery
  • Coagulation disorder
  • Thrombophilia
  • Patients on anticoagulants or antiplatelet agents
  • Patients with a constitutional bone disorder
  • Patients with a syndromic craniofacial malformation
  • Absolute or relative contraindications to treatment with corticosteroids
  • Pregnant (urine test) or breastfeeding women
  • Patients under legal guardianship, conservatorship, or judicial protection
  • Contraindications to the procedure
  • Patients who have taken corticosteroids or NSAIDs on the day before the procedure (D-1).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental arm

with drains placed at the end of the procedure, in addition to standard postoperative care. These will be Redon drains with an outlet that is either intraoral or transcutaneous in the cervical region, depending on the participating center's practices (intraoral transmucosal in the Tours and Angers centers or transcutaneous in the Nantes center); these drains will be removed 6 hours after placement

Translated with DeepL.com (free version)
Procedure: Orthognathic surgery

in which drains are placed at the end of the procedure, in addition to standard postoperative care.
Active Comparator: control arm

which consists of not placing any drainage device immediately after surgery, with standard postoperative care identical to that of the experimental group.
Other: standard postoperative care

not placing any drainage device immediately after surgery, with standard postoperative care identical

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative swelling
Time Frame: Cervicofacial linear measurement will be collected 48 hours after the randomization (day 2) and at month 3. As the facial skeletal anatomy will be modified by the surgical procedure, month 3 will be considered as the baseline measurement.

The primary outcome will be the post operative facial swelling 48 hours after the end of the surgical procedure (randomization will be at this timepoint) measured with cervicofacial linear measurements
Cervicofacial linear measurement will be collected 48 hours after the randomization (day 2) and at month 3. As the facial skeletal anatomy will be modified by the surgical procedure, month 3 will be considered as the baseline measurement.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative swelling
Time Frame: Cervicofacial linear measurement will be collected at 6 hours after randomization, 24 hours after randomization (day 1) and at day 7

Postoperative swelling at other time points than for the primary outcome, measured with cervico facial linear measurements
Cervicofacial linear measurement will be collected at 6 hours after randomization, 24 hours after randomization (day 1) and at day 7
Postoperative swelling
Time Frame: It will be collected 24 hours after randomization (day 1) , at day 2, at day 7 and at month 3

Postoperative swelling using 3D photogrammetry instead of cervicofacial linear measurements
It will be collected 24 hours after randomization (day 1) , at day 2, at day 7 and at month 3
Pain intensity
Time Frame: Pain will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7

Pain will be measured using a visual analog scale where 0 corresponds to no pain and 10 to unbearable pain
Pain will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
Aesthetic discomfort
Time Frame: It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7

Aesthetic discomfort will be measured using a visual analog scale with 0 indicating no discomfort and 10 corresponding to an extremely uncomfortable feeling
It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
Breathing discomfort
Time Frame: It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7

Breathing discomfort will be measured using a visual analog scale where 0 corresponds to no discomfort and 10 to extremely bothersome
It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
Swallowing discomfort
Time Frame: It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7

Swallowing discomfort will be measured using a visual analog scale where 0 corresponds to no discomfort and 10 to extremely bothersome
It will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
Pain during redon drain removal
Time Frame: It will be collected 6 hours after randomization, at time to redon removal.

Pain during redon drain removal will be collected for participants of the experimental group after redon drain removal
It will be collected 6 hours after randomization, at time to redon removal.
The daily bed rest in hours
Time Frame: It will be collected at day 1 and at day 2 (how long the participant stay in his bed in the last 24 hours) as well as at day 7 (how long the participants stay in his bed each day of the last 4 days).

It corresponds to how long, in hours, the participant stays in his bed each day.
It will be collected at day 1 and at day 2 (how long the participant stay in his bed in the last 24 hours) as well as at day 7 (how long the participants stay in his bed each day of the last 4 days).
The general well-being
Time Frame: It will be collected at day 7 and at month 3

General well-being will be assessed using the GHQ-28 self-assessment questionnaire. The GHQ-28 is a questionnaire with 28 items and with scores ranging from 0 - indicating no deterioration in well-being - to 84 - indicating a significant deterioration in well-being.
It will be collected at day 7 and at month 3
The length of hospital stay
Time Frame: a maximum of 90 days

It corresponds to the lenght of the hospital stay, in days (a maximum of 90 days)
a maximum of 90 days
Postoperative adverse events
Time Frame: Throughout the three-month follow-up period, whenever an adverse event occurs

Postoperative adverse events correspond to hematoma, pre-thoracic hematoma spread, and infection
Throughout the three-month follow-up period, whenever an adverse event occurs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne MORICE, Dr, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR260063 - DPO OM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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