Irrigation and Suction Trial to Prevent SSI

Surgical Site Infection Clinical Trial

— I&S  

Official title:

Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611944
• Other study ID #: 215/RC/KEMU
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: November 2022
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be carried out in Lady willingdon Hospital, Lahore. In this study, we will recruit middle-aged and elderly diabetic women who have been assigned to open abdominal hysterectomy due to different gynaecological reasons. This cohort is at great risk of surgical site infection and other risk factors of SSI like hypertension, hepatitis and malignancy may coexist in these women. The study period will span to include three hundred participants as calculated according to sample size. The women will be divided into either an I&S group or a control group by a simple random number container method. The women in the I&S group will be inserted with bilateral drains during surgery in subcutaneous tissue after the closure of the rectus sheath and irrigated with saline followed by suction through syringe suction attached to the wound for rest of the day. The procedure will continue for three days. On the fourth day, drains are removed and stitches are removed on the fourth postoperative day. In the control group, the wound will be closed by interrupted stitches without the insertion of subcutaneous drains. The dressing will be done daily for seven days. patients with no symptoms and signs of SS will be sent home on the eighth postoperative day. The patients will be followed for symptoms of SSI, pain, readmission rate, and other complications at 4,8 and 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 41 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Abdominal Hysterectomy
• Diabete Mellitus
• Diabetes Mellitus
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Irrigation and suction through subcutaneus drains
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.

Locations

Country	Name	City	State
Pakistan	Lady Willingdon Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

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. eColl — View Citation

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 Ca — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSI rate	number(proportion)of surgical site infections in Intervention and control group	first postoperative day to eighth postoperative day
Secondary	length of wound disruption	proportion of wound involved	at the time of diagnosis
Secondary	Depth of wound disruption	involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome	at the time of diagnosis
Secondary	pain score during hospital stay	composit mean pain score from 0-10, 10 will be maximum adverse outcome	from first postoperative day to eightth postoperative day
Secondary	pain score after discharge	composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12	from discharge to completion of 12 postoperative weeks
Secondary	Other complications	complications of wound in I&S group and control group	from discharge to completion of 12 postoperative weeks
Secondary	patient satisfaction	not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome	at12th postoperative weeks completion