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

Phase 2

• Conditions: All Diseases That Require Gastrointestinal Open Surgery
• Interventions: Device: Subcutaneous closed-suction drainage device

• Registration Number: NCT05318430
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-01
• Study First Posted: 2022-04-08
• Last Update Posted: 2022-04-08
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 228

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Subcutaneous closed-suction drainage device	the closed-suction drainage device will be placed subcutaneously when closing the incision

Primary Outcome Measures

Name	Time	Method
Rate of poor healing of incisions	Within 30 days after surgery

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China