Back to resultsEarly Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision
Primary Purpose
Surgical Wound
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Debridement Within 24 Hours After Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound focused on measuring Surgical Wound, Suture, Complication
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
Sites / Locations
- The First Affiliated Hospital of Xi'an Jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Debridement group
Control group
Arm Description
The subjects in this group will be debrided within 24 hours after surgery.
The subjects in this group will experience wound dressing change regularly 24 hours after surgery.
Outcomes
Primary Outcome Measures
healing time, d (day)
since the ending of surgery to stitches off.
Secondary Outcome Measures
incidence of incision complications
The incision complications include infection, dehiscence, fat liquefaction, etc.
Full Information
NCT ID
NCT03798041
First Posted
January 1, 2019
Last Updated
December 7, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT03798041
Brief Title
Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision
Official Title
Early Debridement Within 24 Hours After Surgery Compared Routine Debridement (24 Hours Later) for Wound Healing of Abdominal Incision
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound
Keywords
Surgical Wound, Suture, Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Debridement group
Arm Type
Experimental
Arm Description
The subjects in this group will be debrided within 24 hours after surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The subjects in this group will experience wound dressing change regularly 24 hours after surgery.
Intervention Type
Behavioral
Intervention Name(s)
Debridement Within 24 Hours After Surgery
Intervention Description
Debrided within 24 hours after surgery
Primary Outcome Measure Information:
Title
healing time, d (day)
Description
since the ending of surgery to stitches off.
Time Frame
From date of surgery to the date of stitches off (up to 1 month)
Secondary Outcome Measure Information:
Title
incidence of incision complications
Description
The incision complications include infection, dehiscence, fat liquefaction, etc.
Time Frame
From the date of surgery to stitches off (up to 1 month)
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu-Feng Zhang, MD, PhD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision
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