Irrigation and Suction Trial to Prevent SSI

NCT05611944 | Completed DMC

• 1 other identifier: 215/RC/KEMU
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted on women with risk factors for SSI assigned to gynecological surgery with an open abdominal approach. The participants will be designated to either Irrigation and suction arm by bilateral drain insertion or the control arm by randomization through the parallel assignment. The participants will be followed for the outcome for four days in the hospital and then at 4 weeks, 8 weeks and 12 weeks postoperatively. The primary outcome measure will be the SSI rate. Secondary outcomes will be signs of SSI, post-operative pain, other complications and patient satisfaction.

Conditions

Surgical Site Infection; Diabete Mellitus; Abdominal Hysterectomy

Keywords

suction,; Wound healing; pain; Hysterectomy

Outcome Measures

Primary Outcomes (1)

• SSI rate

  number(proportion)of surgical site infections in Intervention and control group

  first postoperative day to eighth postoperative day

Secondary Outcomes (6)

• length of wound disruption

  at the time of diagnosis

• Depth of wound disruption

  at the time of diagnosis

• pain score during hospital stay

  from first postoperative day to eightth postoperative day

• pain score after discharge

  from discharge to completion of 12 postoperative weeks

• Other complications

  from discharge to completion of 12 postoperative weeks

Study Arms (2)

I&S arm

EXPERIMENTAL

The 150 participants of the experimental arm will be assigned to the I\&S group and they will be inserted bilateral Nelton drains of 24 sizes in the subcutaneous space after the closure of the rectus sheath. Their wound will be irrigated with 500cc Normal saline at running speed followed by suction for a full day. The procedure will be repeated for three consecutive days. The drains will be removed on the fourth postoperative day.

Device: Irrigation and suction through subcutaneus drains

control

NO INTERVENTION

The 150 participants of the non-intervention group will be assigned to the control arm, The wound will be closed by interrupted mattress stitches without the insertion of subcutaneous drains.

Interventions

Irrigation and suction through subcutaneus drains DEVICE

Irrigation of wound will done by attaching 500cc saline to the drain on one side and let it flow freely from the other drain followed by suction of wound by attaching 60cc suction syringes on both sides creating suction pressure for 100 cc fluid.

I&S arm

Eligibility Criteria

• Age: 41 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients
• age above 40years
• BMI\>25kg/m2
• assigned to hysterectomy
• fit for anaesthesia
• patients with other medical disorders like hepatitis and hypertension will also be included in the study.

You may not qualify if:

• a BMI of less than 25kg/m2
• a preoperative haemoglobin level of less than 10 g/dl.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Lady Willingdon Hospital

Lahore, Punjab Province, 042, Pakistan

Location

Related Publications (3)

• Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures. BMC Musculoskelet Disord. 2010 May 6;11:85. doi: 10.1186/1471-2474-11-85.

  PMID: 20459600 BACKGROUND

• Hasan MY, Teo R, Nather A. Negative-pressure wound therapy for management of diabetic foot wounds: a review of the mechanism of action, clinical applications, and recent developments. Diabet Foot Ankle. 2015 Jul 1;6:27618. doi: 10.3402/dfa.v6.27618. eCollection 2015.

  PMID: 26140663 RESULT

• Ivanzov S, Soynov I, Kulyabin Y, Zubritskiy A, Voitov A, Omelchenko A, Arkhipov A, Bogachev-Prokophiev A. Vacuum-assisted closure versus closed irrigation for deep sternal wound infection treatment in infants: a propensity score-matched study. Interact Cardiovasc Thorac Surg. 2019 Nov 1;29(5):776-782. doi: 10.1093/icvts/ivz167.

  PMID: 31361302 RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Diabetes Mellitus; Pain

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Mohammmad Khalid, MBBS,MHM

  Pakistan Institute of Cardiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The groups will be masked to the Outcome assessor by assigning groups A and B instead of group names and the assessor will be kept blinded about which group is the I\&S group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The participants will be randomized by the random number container method into an equal number of I\&S groups and control groups through the parallel assignment.

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 10, 2022
• Study Start: April 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)