Surgical Site InfectionPhase 2/3NCT05989386
Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies
A Phase 2/3 study testing 0.9% saline solution and Povidone-iodine Swab in people with Surgical Site Infection and Surgical Wound, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgical Site Infection, Surgical Wound, Surgical Incision
- What is being tested?
- 0.9% saline solution and Povidone-iodine Swab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Apr 2023to 29 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi
- The age of patients should be between 18-60 years old.
Who cannot join
- Diabetic patients
- Immune-suppressed patients
- Patients taking steroids
- Patients undergoing chemo-radiotherapy.
- Pregnant females
- Previous abdominal surgery within the last 30 days.
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- Presence of concurrent abdominal wall infections.
- Trauma Laparotomies
- Large Bowel perforations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dr. Ruth K. M. Pfau Civil Hospital Karachi
Karachi, Sindh, 74400
Omer Bin khalid, Asst. Prof, +92 321 2040064, dromerkhalid@gmail.com
Omer Bin Khalid, FCPS-II
About this study
Official title: Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of Intraoperative Incision Wound in Preventing Surgical Site Infections in Emergency Laparotomies: A Randomized Controlled Trial
The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are:
- Incidence of SSI after intervention
- Length of hospital stay
Read more
Participants will be randomly assigned to two groups receiving either of the two groups:
Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation.
Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.
- Conditions
- Surgical Site Infection, Surgical Wound, Surgical Incision, Emergency Laparotomies, Laparotomies, Post Operative Wound Infection
- Being tested
- 0.9% saline solution, Povidone-iodine Swab
- Medical subject headings
- Surgical Wound Infection, Surgical Wound, Wound Infection, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% saline solutionProcedure or surgery
During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group.
Povidone-iodine SwabProcedure or surgery
Also called Control
No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Intra-operative wound irrigation of 0.9% solution saline solution Receives: Procedure: 0.9% saline solution |
| Group B | Active comparator | No intra-operative wound lavage done Receives: Procedure: Povidone-iodine Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Superficial Surgical site infections
Development of Superficial Surgical Site Infection as determined by the CDC guidelines.
Measured: Upto 4 weeks post-operatively
Secondary outcomes (1)
Length of Hospital Stay
Number of in-hospital days (from time of admission to time of discharge)
Measured: Upto 4 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start29 Apr 2023
- Primary completion29 Sep 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer bin khalid, Dow University of Health Sciences
- Investigators
- Omer Bin Khalid, Assist Prof., Principal investigator, Dr. Ruth F. M. Pfau Civil Hospital KarachiImrana Zulfikar, Professor, Study director, Dr. Ruth F. M. Pfau Civil Hospital Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989386
- Sponsor's protocol ID
- 2811
- Status last verified
- Jun 2025
- First submitted
- 19 Jul 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of Intraoperative Incision Wound in Preventing Surgical Site Infections in Emergency Laparotomies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05989386
- Acronym / sponsor ID
- 2811
- Conditions
- Surgical Site Infection, Surgical Wound, Surgical Incision, Emergency Laparotomies, Laparotomies, Post Operative Wound Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 29 Sep 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (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 goal of this clinical trial is to compare the outcomes of High-volume saline irrigation vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. The main question it aims to answer are:
- Incidence of SSI after intervention
- Length of hospital stay
Participants will be randomly assigned to two groups receiving either of the two groups:
Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The incisional wound will be closed conventionally without irrigation.
Researchers will compare groups A( experimental group) and B (control group) to compare the incidence of superficial surgical site infections after intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: 0.9% saline solutionIntra-operative wound irrigation of 0.9% solution saline solution |
| Group B | Active comparator | Procedure: Povidone-iodine SwabNo intra-operative wound lavage done |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr. Ruth K. M. Pfau Civil Hospital Karachi
Key exclusion criteria (9 listed)
- Diabetic patients
- Immune-suppressed patients
- Patients taking steroids
- Patients undergoing chemo-radiotherapy.
- Pregnant females
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 |
|---|---|---|
| 0.9% saline solutionDuring emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group. | Procedure or surgery | Group A |
| Povidone-iodine SwabAlso: ControlNo intra-operative wound lavage done, and wound would be cleaned with povidone doused swab. | Procedure or surgery | Group B |
Primary outcome
Incidence of Superficial Surgical site infections
Time frame: Upto 4 weeks post-operatively
Development of Superficial Surgical Site Infection as determined by the CDC guidelines.
1 secondary outcome
Length of Hospital Stay
Time frame: Upto 4 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Omer Bin Khalid, Assist Prof. principal investigator
Dr. Ruth F. M. Pfau Civil Hospital Karachi
Imrana Zulfikar, Professor study director
Dr. Ruth F. M. Pfau Civil Hospital Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.9% saline solution and Povidone-iodine Swab in people with Surgical Site Infection and Surgical Wound, run by Dow University of Health Sciences 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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omer Bin Khalid, Assist Prof. (+92 321 2040064, dromerkhalid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Superficial Surgical site infections (time frame: Upto 4 weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.