Dexamethasone and Wound Healing After Thyroid Surgery
Primary Purpose
Wound Infection
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
saline
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection
Eligibility Criteria
Inclusion Criteria:
- Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer
Exclusion Criteria:
- 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
- Pharyngitis
- Smoking, alcohol drinking history
- Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al)
Sites / Locations
- Shanghai 6Th People'S Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group D
Group S
Arm Description
Group D: dexamethasone group
Group S: saline group
Outcomes
Primary Outcome Measures
the total wound drain after the operation, including the drain in bulb and stain area in dressings,
Secondary Outcome Measures
patient pain scores, including incision pain and throat pain,
c-reaction protein levels in drainage fluid and blood during perioperative period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02304250
Brief Title
Dexamethasone and Wound Healing After Thyroid Surgery
Official Title
The Effect of Dexamethasone on Safety of Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Quanhong Zhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Group D: dexamethasone group
Arm Title
Group S
Arm Type
Placebo Comparator
Arm Description
Group S: saline group
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone 1ml (5mg)
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
saline 1ml
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
patient pain scores, including incision pain and throat pain,
Time Frame
from postoperative day 0 to one month after operation
Title
c-reaction protein levels in drainage fluid and blood during perioperative period.
Time Frame
from postoperative day 0 to postoperative day 4
Other Pre-specified Outcome Measures:
Title
patient nausea/vomiting scores
Time Frame
from postoperative day 0 to 3 days after operation
Title
other side effects from the surgery
Time Frame
from postoperative day 0 to one month after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer
Exclusion Criteria:
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
Pharyngitis
Smoking, alcohol drinking history
Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WEIPING JIA, Ph.D
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai 6Th People'S Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30963205
Citation
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.
Results Reference
derived
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Dexamethasone and Wound Healing After Thyroid Surgery
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