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

Surgical Wound Clinical Trial

Official title:

Early Debridement Within 24 Hours After Surgery Compared Routine Debridement (24 Hours Later) for Wound Healing of Abdominal Incision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798041
• Other study ID #: XJTU1AFCRC2017SJ-007-1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: March 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wound
• Wounds and Injuries

Intervention

Behavioral:
• Debridement Within 24 Hours After Surgery
Debrided within 24 hours after surgery

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)