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

NCT03798041 | Completed

• 1 other identifier: XJTU1AFCRC2017SJ-007-1
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound

Keywords

Surgical Wound; Suture, Complication

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• incidence of incision complications

  From the date of surgery to stitches off (up to 1 month)

Study Arms (2)

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

Debridement Within 24 Hours After Surgery BEHAVIORAL

Debrided within 24 hours after surgery

Debridement group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the patient with major abdominal incision.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Surgical Wound

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Xu-Feng Zhang, MD, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 9, 2019
• Study Start: February 1, 2019
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)