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Subcutaneous 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
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for All Diseases That Require Gastrointestinal Open Surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 1, 2022
Last Updated
April 1, 2022
Sponsor
Beijing Friendship Hospital
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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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