Surgical WoundNCT03798041
Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision
A study testing Debridement Within 24 Hours After Surgery in people with Surgical Wound, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Debridement Within 24 Hours After Surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patient with major abdominal incision.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Early Debridement Within 24 Hours After Surgery Compared Routine Debridement (24 Hours Later) for Wound Healing of Abdominal Incision
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
- Being tested
- Debridement Within 24 Hours After Surgery
- Keywords
- Surgical Wound, Suture, Complication
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debridement Within 24 Hours After SurgeryBehavioural
Debrided within 24 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Debridement group | Experimental | The subjects in this group will be debrided within 24 hours after surgery. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time, d (day)
since the ending of surgery to stitches off.
Measured: From date of surgery to the date of stitches off (up to 1 month)
Secondary outcomes (1)
incidence of incision complications
The incision complications include infection, dehiscence, fat liquefaction, etc.
Measured: From the date of surgery to stitches off (up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Feb 2019
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu-Feng Zhang, MD, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798041
- Sponsor's protocol ID
- XJTU1AFCRC2017SJ-007-1
- Status last verified
- Mar 2021
- First submitted
- 1 Jan 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Debridement Within 24 Hours After Surgery Compared Routine Debridement (24 Hours Later) for Wound Healing of Abdominal Incision
- ClinicalTrials.gov ID
- NCT03798041
- Acronym / sponsor ID
- XJTU1AFCRC2017SJ-007-1
- Conditions
- Surgical Wound
- Keywords
- Surgical Wound, Suture, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debridement group | Experimental | Behavioral: Debridement Within 24 Hours After SurgeryThe subjects in this group will be debrided within 24 hours after surgery. |
| Control group | No intervention | –The subjects in this group will experience wound dressing change regularly 24 hours after surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the patient with major abdominal incision.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debridement Within 24 Hours After SurgeryDebrided within 24 hours after surgery | Behavioural | Debridement group |
Primary outcome
healing time, d (day)
Time frame: From date of surgery to the date of stitches off (up to 1 month)
since the ending of surgery to stitches off.
1 secondary outcome
incidence of incision complications
Time frame: From the date of surgery to stitches off (up to 1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu-Feng Zhang, MD, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debridement Within 24 Hours After Surgery in people with Surgical Wound, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing time, d (day) (time frame: From date of surgery to the date of stitches off (up to 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.