All Diseases That Require Gastrointestinal Open SurgeryPhase 2NCT05318430
Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
A Phase 2 study testing Subcutaneous closed-suction drainage device in people with All Diseases That Require Gastrointestinal Open Surgery, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- All Diseases That Require Gastrointestinal Open Surgery
- What is being tested?
- Subcutaneous closed-suction drainage device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2022
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-85 years old, male or female
- all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal
- open surgery (instead of laparoscopic) required
- willing participated in clinical verification and signed informed consent.
Who cannot join
- laparoscopic surgery
- upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas)
- simple appendectomy / total appendectomy
- hernia surgery and intestinal obstruction surgery without intestinal resection
- infection of incision site before operation
- pregnant women
- expected death within 1 month after operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Jun Li, M.D.
About this study
This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.
- Being tested
- Subcutaneous closed-suction drainage device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous closed-suction drainage deviceDevice
This subcutaneous closed-suction drainage device was designed to be placed subcutaneously when surgeons have completed all intra-abdominal operations and are about to suture subcutaneous layer and skin
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | the closed-suction drainage device will be placed subcutaneously when closing the incision Receives: Device: Subcutaneous closed-suction drainage device |
| Control group | No intervention | the closed-suction drainage device will not be placed subcutaneously when closing the incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of poor healing of incisions
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Diseases That Require Gastrointestinal Open SurgeryStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318430
- Sponsor's protocol ID
- BFH-SCD
- Status last verified
- Apr 2022
- First submitted
- 1 Apr 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Export of individual patient data is not permitted by Chinese laws
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05318430
- Acronym / sponsor ID
- BFH-SCD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Apr 2022 (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.
This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Subcutaneous closed-suction drainage devicethe closed-suction drainage device will be placed subcutaneously when closing the incision |
| Control group | No intervention | –the closed-suction drainage device will not be placed subcutaneously when closing the incision |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18-85 years old, male or female
- all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal
- open surgery (instead of laparoscopic) required
- willing participated in clinical verification and signed informed consent.
Key exclusion criteria (7 listed)
- laparoscopic surgery
- upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas)
- simple appendectomy / total appendectomy
- hernia surgery and intestinal obstruction surgery without intestinal resection
- infection of incision site before operation
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 |
|---|---|---|
| Subcutaneous closed-suction drainage deviceThis subcutaneous closed-suction drainage device was designed to be placed subcutaneously when surgeons have completed all intra-abdominal operations and are about to suture subcutaneous layer and skin | Device | Experimental group |
Primary outcome
Rate of poor healing of incisions
Time frame: Within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: No. Export of individual patient data is not permitted by Chinese laws
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Subcutaneous closed-suction drainage device in people with All Diseases That Require Gastrointestinal Open Surgery, run by Beijing Friendship Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Li, M.D. (+86 13811379656, lijunsy2002@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of poor healing of incisions (time frame: Within 30 days after surgery). 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 8 Apr 2022.