Clinical trial NCT05611944: Irrigation and Suction Trial to Prevent SSI
Official title: Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Diabete Mellitus
Abdominal Hysterectomy
Keywords: suction,
Wound healing
pain
Hysterectomy
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SSI rate
timeFrame: first postoperative day to eighth postoperative day
Secondary outcomes:
measure: length of wound disruption
timeFrame: at the time of diagnosis
measure: Depth of wound disruption
timeFrame: at the time of diagnosis
measure: pain score during hospital stay
timeFrame: from first postoperative day to eightth postoperative day
measure: pain score after discharge
timeFrame: from discharge to completion of 12 postoperative weeks
measure: Other complications
timeFrame: from discharge to completion of 12 postoperative weeks
measure: patient satisfaction
timeFrame: at12th postoperative weeks completion
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lady Willingdon Hospital
state: Punjab
Study officials:
affiliation: Pakistan Institute of Cardiology
name: Mohammmad Khalid, MBBS,MHM
role: STUDY_DIRECTOR
References:
citation: 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.
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. eCollection 2015.
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 Cardiovasc Thorac Surg. 2019 Nov 1;29(5):776-782. doi: 10.1093/icvts/ivz167.