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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Completed

CT.gov ID

NCT03798041

Collaborator

(none)

480

Enrollment

Location

Arms

25.4

Actual Duration (Months)

18.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound	Behavioral: Debridement Within 24 Hours After Surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Mar 16, 2021

Actual Study Completion Date :

Mar 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Debridement group The subjects in this group will be debrided within 24 hours after surgery.	Behavioral: Debridement Within 24 Hours After Surgery Debrided within 24 hours after surgery
No Intervention: Control group The subjects in this group will experience wound dressing change regularly 24 hours after surgery.

Arm

Intervention/Treatment

Experimental: Debridement group

The subjects in this group will be debrided within 24 hours after surgery.

Behavioral: Debridement Within 24 Hours After Surgery

Debrided within 24 hours after surgery

No Intervention: Control group

The subjects in this group will experience wound dressing change regularly 24 hours after surgery.

Outcome Measures

Primary Outcome Measures

healing time, d (day) [From date of surgery to the date of stitches off (up to 1 month)]
since the ending of surgery to stitches off.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT03798041

Other Study ID Numbers:

XJTU1AFCRC2017SJ-007-1

First Posted:

Jan 9, 2019

Last Update Posted:

Dec 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University

Surgical Wound

Suture, Complication

Additional relevant MeSH terms:

Wounds and Injuries

Surgical Wound

Study Results

No Results Posted as of Dec 9, 2021