Effect of Redon-type Drains on Postoperative Edema Following Mandibular Orthognathic Surgery: a Randomized, Controlled Superiority Trial With Two Parallel Arms
NCT07933718, Not applicable, Not yet recruiting, University Hospital, Tours
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Redon-type Drains on Postoperative Edema Following Mandibular Orthognathic Surgery: a Randomized, Controlled Superiority Trial With Two Parallel Arms | ClinicalTrials.gov |
| NCT number | NCT07933718 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 72 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Tours | ClinicalTrials.gov |
| Conditions | Orthognathic Surgical Procedures, Drainage, Oedema | ClinicalTrials.gov |
| Interventions | Orthognathic surgery, standard postoperative care | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Postoperative swelling | 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 | ClinicalTrials.gov |
| Secondary | Postoperative swelling | 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 | ClinicalTrials.gov |
| Secondary | Postoperative swelling | 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 | ClinicalTrials.gov |
| Secondary | Pain intensity | 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 | ClinicalTrials.gov |
| Secondary | Aesthetic discomfort | 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 | ClinicalTrials.gov |
| Secondary | Breathing discomfort | 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 | ClinicalTrials.gov |
| Secondary | Swallowing discomfort | 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 | ClinicalTrials.gov |
| Secondary | Pain during redon drain removal | 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 | ClinicalTrials.gov |
| Secondary | The daily bed rest in hours | 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. | ClinicalTrials.gov |
| Secondary | The general well-being | 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. | ClinicalTrials.gov |
| Secondary | The length of hospital stay | a maximum of 90 days | It corresponds to the lenght of the hospital stay, in days (a maximum of 90 days) | ClinicalTrials.gov |
| Secondary | Postoperative adverse events | Throughout the three-month follow-up period, whenever an adverse event occurs | Postoperative adverse events correspond to hematoma, pre-thoracic hematoma spread, and infection | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)