Early Debridement Within 24 Hours After Surgery for Wound... | NCT03798041

Studies
Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision

NCT03798041

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Completed

Last Update Posted

Dec 9, 2021Actual

Enrollment

480Actual

Phase

Not Applicable

Conditions

Surgical Wound

Interventions

Debridement Within 24 Hours After Surgery

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

Mar 2021

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

Feb 1, 2019Actual

Primary Completion Date

Mar 16, 2021Actual

Completion Date

Mar 16, 2021Actual

First Submitted Date

Jan 1, 2019

First Submission Date that Met QC Criteria

Jan 6, 2019

First Posted Date

Jan 9, 2019Actual

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

Dec 7, 2021

Last Update Posted Date

Dec 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Wound healing after surgery is a complex procedure. Liquefaction of the fat and necrosis of inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours after surgery. As such, early debridement within 24 hours after surgery might improve the healing of the wounds. This study is designed to compare the impact of early debridement of the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be included in this study, and divided into 2 groups randomly. Then, the healing of the wound, stitch removal time, incidence of incision complications will be compared between the two groups.

Detailed Description

Not provided

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

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Debridement group	Experimental	The subjects in this group will be debrided within 24 hours after surgery.	Behavioral: Debridement Within 24 Hours After Surgery
Control group	No Intervention	The subjects in this group will experience wound dressing change regularly 24 hours after surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Debridement Within 24 Hours After Surgery	Behavioral	Debrided within 24 hours after surgery	Debridement group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
healing time, d (day)	since the ending of surgery to stitches off.	From date of surgery to the date of stitches off (up to 1 month)

Secondary Outcomes

Measure	Description	Time Frame
incidence of incision complications	The incision complications include infection, dehiscence, fat liquefaction, etc.	From the date of surgery to stitches off (up to 1 month)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the patient with major abdominal incision.

Exclusion Criteria:

Pregnant woman
Patient with diabetes
Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
Severe lung diseases such as COPD and asthma
Patients undergoing emergent surgery or infectious surgery
Patients with surgical site infection or abdominal abscess
No autonomy, inability or unwillingness to participate in follow-up

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
Xu-Feng Zhang, MD, PhD	First Affiliated Hospital Xi'an Jiaotong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Xi'an Jiaotong University		Xi'an	Shaanxi	710061	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000072836	Surgical Wound

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D011184	Postoperative Period

Ancestor Terms

ID	Term
D059035	Perioperative Period
D013514	Surgical Procedures, Operative
D005791	Patient Care
D006296	Health Services

Browse Leaves

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Browse Branches

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