An interventional study of Orthognathic surgery and standard postoperative care in Orthognathic Surgical Procedures, Drainage and Oedema, sponsored by University Hospital, Tours. Not yet recruiting at 2 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 36 studies in Edema with a site in France — 7 open to participants now, 7 under way, none of them phase 3. Edema · France.
Among the 36 studies in Edema with a site in France, this one is the 12th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2026, is one of 11 with no phase, and was the 36th registered.
567 studies on the registry are indexed under Edema; 96 are open to participants now.
Browse Edema studies →7 of the 36 studies in Edema with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 18+
Hospices Civils de Lyon · Sites in France
Ages 18+
University Hospital, Brest · Sites in France
Ages 18–99
Indiana University · Sites in France, United States, Argentina and 30 more countries
Ages 0 min–2 wk
CHU de Reims · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 56 Edema studies recruiting now, 34 (61%) set no upper age limit and 16 (29%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.
This study: 15 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is above the median of 53 across 402 interventional studies indexed under Edema.
Median enrollment 104 across the 17 interventional studies, 60 across the 19 observational. Of the 21 that completed or were terminated, 2 (10%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 36 have an industry lead sponsor. The 10 most frequent:
University Hospital, Tours is the lead sponsor of 309 studies on the registry; 81 are open to participants now.
University Hospital, Tours has 1 study filed under Edema — fewer than ten, so there is no comparison to draw.
3 of the studies in Edema with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06823115Indiana UniversityAssessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0 | 2027-01 |
| NCT07077772Centre Hospitalier Universitaire, AmiensNatriuresis-guided Depletion After Cardiac Surgery | 2027-10 |
| NCT06799299CHU de ReimsCollapsibility Index of the Inferior Vena Cava and Kidney Transplantation | 2027-11-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 36 studies in Edema with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Enrolled in a French social security program
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
in which drains are placed at the end of the procedure, in addition to standard postoperative care.
not placing any drainage device immediately after surgery, with standard postoperative care identical
Postoperative swelling
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
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.
Postoperative swelling
Postoperative swelling at other time points than for the primary outcome, measured with cervico facial linear measurements
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
Postoperative swelling using 3D photogrammetry instead of cervicofacial linear measurements
Time frame: It will be collected 24 hours after randomization (day 1) , at day 2, at day 7 and at month 3
Pain intensity
Pain will be measured using a visual analog scale where 0 corresponds to no pain and 10 to unbearable pain
Time frame: Pain will be collected 6 hours after randomization, at day 1 (24 hours after randomization), at day 2 and at day 7
Aesthetic discomfort
Aesthetic discomfort will be measured using a visual analog scale with 0 indicating no discomfort and 10 corresponding to an extremely uncomfortable feeling
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
Breathing discomfort will be measured using a visual analog scale where 0 corresponds to no discomfort and 10 to extremely bothersome
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
Swallowing discomfort will be measured using a visual analog scale where 0 corresponds to no discomfort and 10 to extremely bothersome
Time frame: 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
Pain during redon drain removal will be collected for participants of the experimental group after redon drain removal
Time frame: It will be collected 6 hours after randomization, at time to redon removal.
The daily bed rest in hours
It corresponds to how long, in hours, the participant stays in his bed each day.
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).
The general well-being
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.
Time frame: It will be collected at day 7 and at month 3
The length of hospital stay
It corresponds to the lenght of the hospital stay, in days (a maximum of 90 days)
Time frame: a maximum of 90 days
Postoperative adverse events
Postoperative adverse events correspond to hematoma, pre-thoracic hematoma spread, and infection
Time frame: Throughout the three-month follow-up period, whenever an adverse event occurs
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2029, 36 months later.
Of 153 non-industry interventional studies with no phase under Edema, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 36 months is above that.
Counting every sponsor, half of 168 studies reached it within 11 months; a quarter within 6 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.