Surgical Site InfectionI&SNCT05611944
Irrigation and Suction Trial to Prevent SSI
A study testing Irrigation and suction through subcutaneus drains in people with Surgical Site Infection and Diabete Mellitus, run by King Edward Medical University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 41 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Diabete Mellitus, Abdominal Hysterectomy
- What is being tested?
- Irrigation and suction through subcutaneus drains
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2017to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- a BMI of less than 25kg/m2
- a preoperative haemoglobin level of less than 10 g/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Irrigation and suction through subcutaneus drains
- Keywords
- suction,, Wound healing, pain, Hysterectomy
- Medical subject headings
- Surgical Wound Infection, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation and suction through subcutaneus drainsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI rate
number(proportion)of surgical site infections in Intervention and control group
Measured: first postoperative day to eighth postoperative day
Secondary outcomes (6)
length of wound disruption
proportion of wound involved
Measured: at the time of diagnosis
Depth of wound disruption
involving skin margins=1,subctaneous tissue=2,rectus sheath=3,peritoneum=4, 4 is the worst outcome
Measured: at the time of diagnosis
pain score during hospital stay
composit mean pain score from 0-10, 10 will be maximum adverse outcome
Measured: from first postoperative day to eightth postoperative day
pain score after discharge
composite mean pain scorefrom 0-10, 10 will be maximum adverse outcome on week4, week8, week12
Measured: from discharge to completion of 12 postoperative weeks
Other complications
complications of wound in I\&S group and control group
Measured: from discharge to completion of 12 postoperative weeks
patient satisfaction
not satisfied=0, satisfied=1,very satisfied=2,2 is best outcome
Measured: at12th postoperative weeks completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Apr 2017
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazia Saaqib, King Edward Medical University
- Investigators
- Mohammmad Khalid, MBBS,MHM, Study director, Pakistan Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611944
- Sponsor's protocol ID
- 215/RC/KEMU
- Acronym
- I&S
- Status last verified
- Nov 2022
- First submitted
- 29 Oct 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be shared after publication of the study.
Publications
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.
PubMed 20459600Hasan 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.
PubMed 26140663Ivanzov 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.
PubMed 31361302
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparotomy Wound Care With Irrigation and Negative Pressure Technique in High-risk Cases of Surgical Site Infection(SSI)-A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05611944
- Acronym / sponsor ID
- I&S / 215/RC/KEMU
- Keywords
- suction,, Wound healing, pain, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| I&S arm | Experimental | Device: Irrigation and suction through subcutaneus drainsThe 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. |
| 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. |
Who may qualify
- Ages
- 41 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetic patients
- age above 40years
- BMI>25kg/m2
- assigned to hysterectomy
- fit for anaesthesia
Key exclusion criteria (2 listed)
- a BMI of less than 25kg/m2
- a preoperative haemoglobin level of less than 10 g/dl.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigation and suction through subcutaneus drainsIrrigation 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. | Device | I&S arm |
Primary outcome
SSI rate
Time frame: first postoperative day to eighth postoperative day
number(proportion)of surgical site infections in Intervention and control group
6 secondary outcomes
length of wound disruption
Time frame: at the time of diagnosis
Depth of wound disruption
Time frame: at the time of diagnosis
pain score during hospital stay
Time frame: from first postoperative day to eightth postoperative day
pain score after discharge
Time frame: from discharge to completion of 12 postoperative weeks
Other complications
Time frame: from discharge to completion of 12 postoperative weeks
patient satisfaction
Time frame: at12th postoperative weeks completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Background: PubMed 20459600Flow 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.
- Results publication: PubMed 26140663Hasan 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.
- Results publication: PubMed 31361302Ivanzov 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.
- Individual participant dataSharing planned: No. The IPD will be shared after publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammmad Khalid, MBBS,MHM study director
Pakistan Institute of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation and suction through subcutaneus drains in people with Surgical Site Infection and Diabete Mellitus, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI rate (time frame: first postoperative day to eighth postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611944, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.