Wound InfectionNCT02304250
Dexamethasone and Wound Healing After Thyroid Surgery
A study testing Dexamethasone and saline in people with Wound Infection, run by Quanhong Zhou at 1 site in China.
Trial summary
Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3]. Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce post-operative nausea and vomiting (PONV), pain and sore throat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- Dexamethasone and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Jul 2015
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer
Who cannot join
- Age > 65 years, < 18 years
- Thyroid tumor with Grave's disease
- Thyroid tumor size over 5 cm
- Second or more than 2 times for thyroid surgery
- Non-traditional pathway for thyroid surgery
- ASA > II
Show all 9Show fewer
- Pharyngitis
- Smoking, alcohol drinking history
- Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai 6Th People'S Hospital
Shanghai, Shanghai Municipality, 200233
About this study
Official title: The Effect of Dexamethasone on Safety of Thyroid Surgery
Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3]. Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce post-operative nausea and vomiting (PONV), pain and sore throat. There are also some reports on beneficial effects of less cardiac arrhythmia, improved appetite and less edema from glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent reversal laryngeal nerve injury and improve voice quality after thyroid surgery. While accepted wildly in clinical anesthesia practice, the immune-press related potential risks of side effects associated with dexamethasone, such as delayed wound healing, infection, as well as effects on blood sugar, make the use of perioperative single dose of glucocorticoid controversial. The effect of perioperative dexamethasone on wound healing varied with different types of surgery. The present study will observe the effect of dexamethasone on the safety of thyroid surgery.
Read the detailed description
Patients who has the thyroid surgery for their thyroid cancer will be randomly allocated into two groups, either dexamethasone group or saline group. In the dexamethasone group, patients will receive 5mg dexamethasone iv right after general anesthesia induction while in the saline group, patients will have 1ml saline iv. The drainage fluid will be collected at 6 hours after surgery and on every morning after operation till the drainage tube is taken out. The total amount of drainage fluid and blood stain area in dressing will be collected and calculated after the operation. The C-reaction protein is checked in drainage fluid and in blood after operation. Besides, the pain scores of incision pain and throat pain will be evaluated. Postoperative nausea and vomit will be checked as well.
- Conditions
- Wound Infection
- Being tested
- Dexamethasone, saline
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
dexamethasone 1ml (5mg)
salineDrug
saline 1ml
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | Group D: dexamethasone group Receives: Drug: Dexamethasone |
| Group S | Placebo comparator | Group S: saline group Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total wound drain after the operation, including the drain in bulb and stain area in dressings,
Measured: from postoperative day 0 to postoperative day 4
Secondary outcomes (2)
patient pain scores, including incision pain and throat pain,
Measured: from postoperative day 0 to one month after operation
c-reaction protein levels in drainage fluid and blood during perioperative period.
Measured: from postoperative day 0 to postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanhong Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quanhong Zhou, Shanghai 6th People's Hospital
- Investigators
- WEIPING JIA, Ph.D, Study chair, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304250
- Sponsor's protocol ID
- 2014-50
- Status last verified
- Nov 2015
- First submitted
- 19 Nov 2014
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang H, Lu J, Wu Q, Wu B, Xu C, Fan Y, Zhou Q. A Perioperative Small Dose of Dexamethasone Enhances Postoperative Recovery by Reducing Volume and Inflammatory Contents in Wound Drainage After Thyroid Surgery: A Double-Blinded, Randomized, Prospective Study. World J Surg. 2019 Jul;43(7):1721-1727. doi: 10.1007/s00268-019-04986-0.
PubMed 30963205
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone on Safety of Thyroid Surgery
- ClinicalTrials.gov ID
- NCT02304250
- Acronym / sponsor ID
- 2014-50
- Conditions
- Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Quanhong ZhouUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Dec 2014 (estimated)
- 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.
Dexamethasone is a potent glucocorticoid with analgesic and anti-emetic effects [1-3]. Perioperative single-dose dexamethasone therapy has been used for several purposes: to reduce post-operative nausea and vomiting (PONV), pain and sore throat. There are also some reports on beneficial effects of less cardiac arrhythmia, improved appetite and less edema from glucocorticoids. Preoperative small dose of dexamethasone was reported to prevent reversal laryngeal nerve injury and improve voice quality after thyroid surgery. While accepted wildly in clinical anesthesia practice, the immune-press related potential risks of side effects associated with dexamethasone, such as delayed wound healing, infection, as well as effects on blood sugar, make the use of perioperative single dose of glucocorticoid controversial. The effect of perioperative dexamethasone on wound healing varied with different types of surgery. The present study will observe the effect of dexamethasone on the safety of thyroid surgery.
Detailed description
Patients who has the thyroid surgery for their thyroid cancer will be randomly allocated into two groups, either dexamethasone group or saline group. In the dexamethasone group, patients will receive 5mg dexamethasone iv right after general anesthesia induction while in the saline group, patients will have 1ml saline iv. The drainage fluid will be collected at 6 hours after surgery and on every morning after operation till the drainage tube is taken out. The total amount of drainage fluid and blood stain area in dressing will be collected and calculated after the operation. The C-reaction protein is checked in drainage fluid and in blood after operation. Besides, the pain scores of incision pain and throat pain will be evaluated. Postoperative nausea and vomit will be checked as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: DexamethasoneGroup D: dexamethasone group |
| Group S | Placebo comparator | Drug: salineGroup S: saline group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer
Key exclusion criteria (9 listed)
- Age > 65 years, < 18 years
- Thyroid tumor with Grave's disease
- Thyroid tumor size over 5 cm
- Second or more than 2 times for thyroid surgery
- Non-traditional pathway for thyroid surgery
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 |
|---|---|---|
| Dexamethasonedexamethasone 1ml (5mg) | Drug | Group D |
| salinesaline 1ml | Drug | Group S |
Primary outcome
the total wound drain after the operation, including the drain in bulb and stain area in dressings,
Time frame: from postoperative day 0 to postoperative day 4
2 secondary outcomes
patient pain scores, including incision pain and throat pain,
Time frame: from postoperative day 0 to one month after operation
c-reaction protein levels in drainage fluid and blood during perioperative period.
Time frame: from postoperative day 0 to postoperative day 4
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 30 Nov 2015.
- Derived from this study: PubMed 30963205Zhang H, Lu J, Wu Q, Wu B, Xu C, Fan Y, Zhou Q. A Perioperative Small Dose of Dexamethasone Enhances Postoperative Recovery by Reducing Volume and Inflammatory Contents in Wound Drainage After Thyroid Surgery: A Double-Blinded, Randomized, Prospective Study. World J Surg. 2019 Jul;43(7):1721-1727. doi: 10.1007/s00268-019-04986-0.
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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.
WEIPING JIA, Ph.D study chair
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and saline in people with Wound Infection, run by Quanhong Zhou at 1 site in China.
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 9 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 30 Nov 2015. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
the total wound drain after the operation, including the drain in bulb and stain area in dressings, (time frame: from postoperative day 0 to postoperative day 4). 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 NCT02304250, which also lists 1 linked publication.
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 30 Nov 2015.