Post-operative EdemaPhase 4NCT03190642
Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery
A Phase 4 study testing Methylprednisolone in people with Post-operative Edema and Steroid Use, run by Jean Charles Doucet at 1 site in Canada.
Trial summary
The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Edema, Steroid Use
- What is being tested?
- Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients age 14 and over undergoing orthognathic surgery at the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia will be included in our study. The clinic is located in the Victoria General Hospital in Halifax, Nova Scotia. Orthognathic surgery includes any combination of Lefort 1, Bilateral Sagittal Split Osteotomy (BSSO) and functional genioplasty procedures.
Who cannot join
- Patients with pertinent medical history that precludes the use of high-dose steroids will be excluded from our study. This includes:
- Known hypersensitivity to steroids
- Type 1 diabetic patients who may have a severe elevation of blood sugars with steroid use.
- Systemic fungal infections
- Arrested tuberculosis
- Herpes simplex keratitis
Show all 10Show fewer
- Acute psychoses
- Cushing's syndrome
- Peptic ulcer disease
- Pregnant patients and patients with current infections will be excluded Breast feeding mother
Trial locations and contacts
1 site in 1 country.
About this study
The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.
The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone.
Read the detailed description
Orthognathic surgery is a commonly performed surgery to correct facial functional and esthetic deformities. At the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia, over 300 of these surgeries are carried out yearly. Orthognathic surgery is comprised of procedures performed in both the maxilla and mandible which include Lefort 1, bilateral sagittal split and functional (BSSO) and functional genioplasty. Common sequelae after orthognathic surgery include post-operative pain and swelling.
Swelling occurs almost universally to some degree after orthognathic surgery. Steroid therapy has long been advocated for the reduction of post-operative swelling in oro-facial surgeries, as there is good evidence to support its use for this purpose. In 1978, Habal showed that one gram of methylprednisolone administered in a controlled dog model reduced post-operative swelling. He later carried this over to his practice of cosmetic facial surgeries. His studies have laid the much of the ground work for the use of steroid therapy in head and neck surgeries today.
Other studied benefits of steroid use in facial surgery include decreased post-operative pain, trismus, nausea and vomiting as well as decreased length of hospital stays. Complications of steroid use include compromised healing or infection, sleep disturbances, hyperglycemia, avascular necrosis of bone, steroid-related acne and adverse psychiatric effects.
The use of perioperative steroids as a means of swelling control is the current standard of care in the practice of orthognathic surgery. Despite this fact, there is little consensus on the ideal steroid regimen (i.e. type and dosing) to use for surgery. As such, the use of steroids in Oral and Maxillofacial surgical practices are based primarily on surgeon's preference and familiarity with a particular steroid regimen. This is likely due to the weak evidence in published literature in favor of a steroid regimen to mitigate post-operative swelling.
Most literature in favor of particular steroid regimens involves crude or arbitrary measurements of swelling. In 1978, Habal showed that one gram of methylprednisolone administered in a controlled dog model reduced post-operative swelling. This observation was made by a trained observer against a control group who received no steroid. Other studies have had trained observers look at post-operative photographs of patients who had undergone orthognathic surgery to stratify which had "more" or "less" swelling. Another study attempted to quantify the degree of post-operative swelling by measuring the distance between the earlobes under the chin. These authors acknowledged that this could be altered by the facial movements produced during orthognathic surgery and that better means of measurement of facial swelling should be employed in future research.
The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.
The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone, which is the current standard of care in our department. One hundred and twenty-five milligrams of methylprednisolone is a readily available dose of steroids and has been shown in several studies to be effective in the reduction of swelling after oral surgeries and other swelling-related conditions. In their systematic literature review of corticosteroid administration in oral and orthognathic surgery, Dan et al. concluded that a preoperative dose of methylprednisolone >85mg results in a significant decrease in post-operative oedema. The researchers hypothesize that there will be little difference between groups with regards to primary study outcome measure of post-operative swelling.
- Conditions
- Post-operative Edema, Steroid Use
- Being tested
- Methylprednisolone
- Keywords
- Orthognathic Surgery, Swelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Solumedrol
Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1000mg methylprednisolone group | Active comparator | Evaluating effects of 1000mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling. Receives: Drug: Methylprednisolone |
| 125mg methylprednisolone group | Active comparator | Evaluating effects of 125mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative edema
Measurement of post-operative edema using 3D facial scanner
Measured: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first
Secondary outcomes (6)
Patient perceived swelling
Measurement of post-operative patient perceived swelling via survey
Measured: Post-operative day 2
Post-operative pain
Measurement of post-operative pain via survey
Measured: Post-operative day 2
Post-operative sleep
Measurement of post-operative sleep via survey
Measured: Post-operative day 2
Post-operative nausea
Measurement of post-operative nausea via survey
Measured: Post-operative day 2
Length of hospital stay
Measurement of length of post-operative hospital stay
Measured: Until discharge from hospital or post-operative day 100, which ever comes first
Rate of post-operative infection
Measurement of post-operative infections
Measured: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, which ever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jan 2018
- Primary completion1 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Post-operative EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Charles Doucet
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, Jean Charles Doucet, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190642
- Sponsor's protocol ID
- OMFSTEROIDS
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NO IPD will be shared with researchers outside of the study
Publications
Guernsey LH, DeChamplain RW. Sequelae and complications of the intraoral sagittal osteotomy in the mandibular rami. Oral Surg Oral Med Oral Pathol. 1971 Aug;32(2):176-92. doi: 10.1016/0030-4220(71)90221-0. No abstract available.
PubMed 5284103Dan AE, Thygesen TH, Pinholt EM. Corticosteroid administration in oral and orthognathic surgery: a systematic review of the literature and meta-analysis. J Oral Maxillofac Surg. 2010 Sep;68(9):2207-20. doi: 10.1016/j.joms.2010.04.019. Epub 2010 Jun 29.
PubMed 20591548Habal MB, Powell RD. Experimental facial edema: treatment with methylprednisolone. J Surg Res. 1978 May;24(5):353-8. doi: 10.1016/0022-4804(78)90026-4. No abstract available.
PubMed 651330Habal MB. Prevention of postoperative facial edema with steroids after facial surgery. Aesthetic Plast Surg. 1985;9(2):69-71. doi: 10.1007/BF01570331.
PubMed 4025052Chegini S, Dhariwal DK. Review of evidence for the use of steroids in orthognathic surgery. Br J Oral Maxillofac Surg. 2012 Mar;50(2):97-101. doi: 10.1016/j.bjoms.2010.11.019. Epub 2011 Feb 12.
PubMed 21316821Huaman ET, Juvet LM, Nastri A, Denman WT, Kaban LB, Dodson TB. Changing patterns of hospital length of stay after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):492-7. doi: 10.1016/j.joms.2007.08.025.
PubMed 18280382Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.
PubMed 20599080Precious DS, Hoffman CD, Miller R. Steroid acne after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1992 Sep;74(3):279-81. doi: 10.1016/0030-4220(92)90058-x.
PubMed 1407985Galen DM, Beck M, Buchbinder D. Steroid psychosis after orthognathic surgery: a case report. J Oral Maxillofac Surg. 1997 Mar;55(3):294-7. doi: 10.1016/s0278-2391(97)90546-2. No abstract available.
PubMed 9054921Weber CR, Griffin JM. Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg. 1994 Jan;52(1):35-9. doi: 10.1016/0278-2391(94)90010-8.
PubMed 8263640Widar F, Kashani H, Alsen B, Dahlin C, Rasmusson L. The effects of steroids in preventing facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy: a randomized controlled trial. Int J Oral Maxillofac Surg. 2015 Feb;44(2):252-8. doi: 10.1016/j.ijom.2014.08.002. Epub 2014 Oct 7.
PubMed 25304755van der Meer WJ, Dijkstra PU, Visser A, Vissink A, Ren Y. Reliability and validity of measurements of facial swelling with a stereophotogrammetry optical three-dimensional scanner. Br J Oral Maxillofac Surg. 2014 Dec;52(10):922-7. doi: 10.1016/j.bjoms.2014.08.019. Epub 2014 Sep 15.
PubMed 25219776Lubbers HT, Medinger L, Kruse A, Gratz KW, Matthews F. Precision and accuracy of the 3dMD photogrammetric system in craniomaxillofacial application. J Craniofac Surg. 2010 May;21(3):763-7. doi: 10.1097/SCS.0b013e3181d841f7.
PubMed 20485043Esen E, Tasar F, Akhan O. Determination of the anti-inflammatory effects of methylprednisolone on the sequelae of third molar surgery. J Oral Maxillofac Surg. 1999 Oct;57(10):1201-6; discussion 1206-8. doi: 10.1016/s0278-2391(99)90486-x.
PubMed 10513866Ichinose M, Sugiura H, Nagase H, Yamaguchi M, Inoue H, Sagara H, Tamaoki J, Tohda Y, Munakata M, Yamauchi K, Ohta K; Japanese Society of Allergology. Japanese guidelines for adult asthma 2017. Allergol Int. 2017 Apr;66(2):163-189. doi: 10.1016/j.alit.2016.12.005. Epub 2017 Feb 11.
PubMed 28196638
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT03190642
- Acronym / sponsor ID
- OMFSTEROIDS
- Conditions
- Post-operative Edema, Steroid Use
- Keywords
- Orthognathic Surgery, Swelling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Jean Charles DoucetUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.
The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone.
Detailed description
Orthognathic surgery is a commonly performed surgery to correct facial functional and esthetic deformities. At the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia, over 300 of these surgeries are carried out yearly. Orthognathic surgery is comprised of procedures performed in both the maxilla and mandible which include Lefort 1, bilateral sagittal split and functional (BSSO) and functional genioplasty. Common sequelae after orthognathic surgery include post-operative pain and swelling.
Swelling occurs almost universally to some degree after orthognathic surgery. Steroid therapy has long been advocated for the reduction of post-operative swelling in oro-facial surgeries, as there is good evidence to support its use for this purpose. In 1978, Habal showed that one gram of methylprednisolone administered in a controlled dog model reduced post-operative swelling. He later carried this over to his practice of cosmetic facial surgeries. His studies have laid the much of the ground work for the use of steroid therapy in head and neck surgeries today.
Other studied benefits of steroid use in facial surgery include decreased post-operative pain, trismus, nausea and vomiting as well as decreased length of hospital stays. Complications of steroid use include compromised healing or infection, sleep disturbances, hyperglycemia, avascular necrosis of bone, steroid-related acne and adverse psychiatric effects.
The use of perioperative steroids as a means of swelling control is the current standard of care in the practice of orthognathic surgery. Despite this fact, there is little consensus on the ideal steroid regimen (i.e. type and dosing) to use for surgery. As such, the use of steroids in Oral and Maxillofacial surgical practices are based primarily on surgeon's preference and familiarity with a particular steroid regimen. This is likely due to the weak evidence in published literature in favor of a steroid regimen to mitigate post-operative swelling.
Most literature in favor of particular steroid regimens involves crude or arbitrary measurements of swelling. In 1978, Habal showed that one gram of methylprednisolone administered in a controlled dog model reduced post-operative swelling. This observation was made by a trained observer against a control group who received no steroid. Other studies have had trained observers look at post-operative photographs of patients who had undergone orthognathic surgery to stratify which had "more" or "less" swelling. Another study attempted to quantify the degree of post-operative swelling by measuring the distance between the earlobes under the chin. These authors acknowledged that this could be altered by the facial movements produced during orthognathic surgery and that better means of measurement of facial swelling should be employed in future research.
The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.
The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone, which is the current standard of care in our department. One hundred and twenty-five milligrams of methylprednisolone is a readily available dose of steroids and has been shown in several studies to be effective in the reduction of swelling after oral surgeries and other swelling-related conditions. In their systematic literature review of corticosteroid administration in oral and orthognathic surgery, Dan et al. concluded that a preoperative dose of methylprednisolone >85mg results in a significant decrease in post-operative oedema. The researchers hypothesize that there will be little difference between groups with regards to primary study outcome measure of post-operative swelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1000mg methylprednisolone group | Active comparator | Drug: MethylprednisoloneEvaluating effects of 1000mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling. |
| 125mg methylprednisolone group | Active comparator | Drug: MethylprednisoloneEvaluating effects of 125mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients age 14 and over undergoing orthognathic surgery at the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia will be included in our study. The clinic is located in the Victoria General Hospital in Halifax, Nova Scotia. Orthognathic surgery includes any combination of Lefort 1, Bilateral Sagittal Split Osteotomy (BSSO) and functional genioplasty procedures.
Key exclusion criteria (10 listed)
- Patients with pertinent medical history that precludes the use of high-dose steroids will be excluded from our study. This includes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneAlso: SolumedrolAdministration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery. | Drug | 1000mg methylprednisolone group, 125mg methylprednisolone group |
Primary outcome
Post-operative edema
Time frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first
Measurement of post-operative edema using 3D facial scanner
6 secondary outcomes
Patient perceived swelling
Time frame: Post-operative day 2
Post-operative pain
Time frame: Post-operative day 2
Post-operative sleep
Time frame: Post-operative day 2
Post-operative nausea
Time frame: Post-operative day 2
Length of hospital stay
Time frame: Until discharge from hospital or post-operative day 100, which ever comes first
Rate of post-operative infection
Time frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, which ever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 5284103Guernsey LH, DeChamplain RW. Sequelae and complications of the intraoral sagittal osteotomy in the mandibular rami. Oral Surg Oral Med Oral Pathol. 1971 Aug;32(2):176-92. doi: 10.1016/0030-4220(71)90221-0. No abstract available.
- Background: PubMed 20591548Dan AE, Thygesen TH, Pinholt EM. Corticosteroid administration in oral and orthognathic surgery: a systematic review of the literature and meta-analysis. J Oral Maxillofac Surg. 2010 Sep;68(9):2207-20. doi: 10.1016/j.joms.2010.04.019. Epub 2010 Jun 29.
- Background: PubMed 651330Habal MB, Powell RD. Experimental facial edema: treatment with methylprednisolone. J Surg Res. 1978 May;24(5):353-8. doi: 10.1016/0022-4804(78)90026-4. No abstract available.
- Background: PubMed 4025052Habal MB. Prevention of postoperative facial edema with steroids after facial surgery. Aesthetic Plast Surg. 1985;9(2):69-71. doi: 10.1007/BF01570331.
- Background: PubMed 21316821Chegini S, Dhariwal DK. Review of evidence for the use of steroids in orthognathic surgery. Br J Oral Maxillofac Surg. 2012 Mar;50(2):97-101. doi: 10.1016/j.bjoms.2010.11.019. Epub 2011 Feb 12.
- Background: PubMed 18280382Huaman ET, Juvet LM, Nastri A, Denman WT, Kaban LB, Dodson TB. Changing patterns of hospital length of stay after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):492-7. doi: 10.1016/j.joms.2007.08.025.
- Background: PubMed 20599080Poetker DM, Reh DD. A comprehensive review of the adverse effects of systemic corticosteroids. Otolaryngol Clin North Am. 2010 Aug;43(4):753-68. doi: 10.1016/j.otc.2010.04.003.
- Background: PubMed 1407985Precious DS, Hoffman CD, Miller R. Steroid acne after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1992 Sep;74(3):279-81. doi: 10.1016/0030-4220(92)90058-x.
- Background: PubMed 9054921Galen DM, Beck M, Buchbinder D. Steroid psychosis after orthognathic surgery: a case report. J Oral Maxillofac Surg. 1997 Mar;55(3):294-7. doi: 10.1016/s0278-2391(97)90546-2. No abstract available.
- Background: PubMed 8263640Weber CR, Griffin JM. Evaluation of dexamethasone for reducing postoperative edema and inflammatory response after orthognathic surgery. J Oral Maxillofac Surg. 1994 Jan;52(1):35-9. doi: 10.1016/0278-2391(94)90010-8.
- Background: PubMed 25304755Widar F, Kashani H, Alsen B, Dahlin C, Rasmusson L. The effects of steroids in preventing facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy: a randomized controlled trial. Int J Oral Maxillofac Surg. 2015 Feb;44(2):252-8. doi: 10.1016/j.ijom.2014.08.002. Epub 2014 Oct 7.
- Background: PubMed 25219776van der Meer WJ, Dijkstra PU, Visser A, Vissink A, Ren Y. Reliability and validity of measurements of facial swelling with a stereophotogrammetry optical three-dimensional scanner. Br J Oral Maxillofac Surg. 2014 Dec;52(10):922-7. doi: 10.1016/j.bjoms.2014.08.019. Epub 2014 Sep 15.
- Individual participant dataSharing planned: No. NO IPD will be shared with researchers outside of the study
Related trials for Post-operative Edema
Active, not recruitingObservational study
Diabetic Nephropathy, Glycemic Control and Pseudophakic Macular Edema After Cataract Surgery
Pseudophakic Macular Edema, Diabetic Nephropathies
Recruiting
Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages
Limb Edema, Surgical Site Infections
RecruitingPhase 4
The PRIME Study: A Randomized, Controlled, Prospective Study
Patient Preference, Patient Outcomes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone in people with Post-operative Edema and Steroid Use, run by Jean Charles Doucet at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative edema (time frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03190642, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.