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

Study Overview

• Status: Recruiting
• Conditions: All Diseases That Require Gastrointestinal Open Surgery
• Intervention / Treatment: Device: Subcutaneous closed-suction drainage device

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jun Li, M.D.; Phone Number: +86 13811379656; Email: lijunsy2002@ccmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Friendship Hospital, Capital Medical University
    • Contact: Jun Li, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; the closed-suction drainage device will be placed subcutaneously when closing the incision	Device: 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
No Intervention: Control group; the closed-suction drainage device will not be placed subcutaneously when closing the incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of poor healing of incisions	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: BFH-SCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Export of individual patient data is not permitted by Chinese laws

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No