Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study

NCT ID: NCT05318430

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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All Diseases That Require Gastrointestinal Open Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

the closed-suction drainage device will be placed subcutaneously when closing the incision

Group Type EXPERIMENTAL

Subcutaneous closed-suction drainage device

Intervention Type DEVICE

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

Control group

the closed-suction drainage device will not be placed subcutaneously when closing the incision

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Subcutaneous closed-suction drainage device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun Li, M.D.

Role: CONTACT

+86 13811379656

Facility Contacts

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Jun Li, M.D.

Role: primary

Other Identifiers

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BFH-SCD

Identifier Type: -

Identifier Source: org_study_id

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