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

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Capital Medical University

Status and phase

Unknown
Phase 2

Conditions

All Diseases That Require Gastrointestinal Open Surgery

Treatments

Device: Subcutaneous closed-suction drainage device

Study type

Interventional

Funder types

Other

Identifiers

NCT05318430
BFH-SCD

Details and patient eligibility

About

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.

Enrollment

228 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

228 participants in 2 patient groups

Experimental group
Experimental group
Description:
the closed-suction drainage device will be placed subcutaneously when closing the incision
Treatment:
Device: Subcutaneous closed-suction drainage device
Control group
No Intervention group
Description:
the closed-suction drainage device will not be placed subcutaneously when closing the incision

Trial contacts and locations

1

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Central trial contact

Jun Li, M.D.

Data sourced from clinicaltrials.gov

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