Dexamethasone and Wound Healing After Thyroid Surgery | NCT02304250

Studies
Dexamethasone and Wound Healing After Thyroid Surgery

NCT02304250

Sponsor

Quanhong Zhou

Status

Completed

Last Update Posted

Nov 30, 2015Estimated

Enrollment

220Actual

Phase

Not Applicable

Conditions

Wound Infection

Interventions

Dexamethasone
saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Nov 19, 2014

First Submission Date that Met QC Criteria

Nov 25, 2014

First Posted Date

Dec 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Quanhong Zhou, Doctor, Shanghai 6th People's HospitalSponsor-Investigator

Lead Sponsor

Quanhong ZhouOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group D	Active Comparator	Group D: dexamethasone group	Drug: Dexamethasone
Group S	Placebo Comparator	Group S: saline group	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	dexamethasone 1ml (5mg)	Group D
saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the total wound drain after the operation, including the drain in bulb and stain area in dressings,		from postoperative day 0 to postoperative day 4

Secondary Outcomes

Measure	Description	Time Frame
patient pain scores, including incision pain and throat pain,		from postoperative day 0 to one month after operation
c-reaction protein levels in drainage fluid and blood during perioperative period.		from postoperative day 0 to postoperative day 4

Other Outcomes

Measure	Description	Time Frame
patient nausea/vomiting scores		from postoperative day 0 to 3 days after operation
other side effects from the surgery		from postoperative day 0 to one month after the operation

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
WEIPING JIA, Ph.D	Shanghai Jiao Tong University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai 6Th People'S Hospital		Shanghai	Shanghai Municipality	200233	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30963205	Derived	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.

ID	Term
D003907	Dexamethasone
D012965	Sodium Chloride

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids