Back to resultsSubcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
Primary Purpose
All Diseases That Require Gastrointestinal Open Surgery
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Subcutaneous closed-suction drainage device
Sponsored by
About this trial
This is an interventional treatment trial for All Diseases That Require Gastrointestinal Open Surgery
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Beijing Friendship Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
the closed-suction drainage device will be placed subcutaneously when closing the incision
the closed-suction drainage device will not be placed subcutaneously when closing the incision
Outcomes
Primary Outcome Measures
Rate of poor healing of incisions
Secondary Outcome Measures
Full Information
NCT ID
NCT05318430
First Posted
April 1, 2022
Last Updated
April 1, 2022
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05318430
Brief Title
Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
Official Title
Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
All Diseases That Require Gastrointestinal Open Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
the closed-suction drainage device will be placed subcutaneously when closing the incision
Arm Title
Control group
Arm Type
No Intervention
Arm Description
the closed-suction drainage device will not be placed subcutaneously when closing the incision
Intervention Type
Device
Intervention Name(s)
Subcutaneous closed-suction drainage device
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of poor healing of incisions
Time Frame
Within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Li, M.D.
Phone
+86 13811379656
Email
lijunsy2002@ccmu.edu.cn
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Li, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Export of individual patient data is not permitted by Chinese laws
Learn more about this trial
Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
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