Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution (PLaSSo)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04512196 |
|
Recruitment Status :
Recruiting
First Posted : August 13, 2020
Last Update Posted : August 25, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perforated Appendicitis | Drug: Superoxidized Water Drug: Normal Saline | Not Applicable |
Open appendicectomy for perforated appendicitis is associated with significant morbidity from surgical site infection. The standard practice is to perform peritoneal and wound lavage using normal saline solution. The investigators propose the use of superoxidized solution for peritoneal and wound lavage to decrease the incidence of surgical site infection.
Superoxidized solutions contain hypochlorous acid (HOCl) which has bactericidal properties. The reactive oxygen species that is produces damages cell wall membrane of unicellular organisms, however remains safe when in contact with human or animal tissue. It is commonly used for topical treatment of wounds.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 102 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomised double-blind placebo-controlled parallel-group study. This is a superiority study assessing the effectiveness of the intervention |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The study participants, healthcare providers who attend to the participants during the trial (surgeon and nurses), outcome evaluators (surgical doctors and nurses) and data collectors will be blinded to the allocation. The sterile study solution (super-oxidised solution) or placebo (normal saline 0.9%) will be stored in a similar storage container and will have the same clear appearance. |
| Primary Purpose: | Treatment |
| Official Title: | Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial |
| Actual Study Start Date : | September 9, 2020 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | September 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Super-oxidised Solution
Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg
|
Drug: Superoxidized Water
Super-oxidized solution contains hypochlorous acid (HOCl) which exhibits bactericidal activity. These reactive species create an imbalanced osmotic gradient which damages the cell membrane integrity of single celled organisms, and subsequently denaturing its lipid and protein content. Multicellular organisms including host tissue are not susceptible to such changes in osmolarity hence spared from damage.
Other Name: Hydrocyn Aqua® (Vigilenz MD., Penang, Malaysia); FDA 510(K) Number: K142775 |
|
Placebo Comparator: Normal Saline
Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg
|
Drug: Normal Saline
Normal saline contains 0.9% sodium chloride. |
- Surgical site infection [ Time Frame: 30 days post surgery ]Number of participants with surgical site infection after open surgery for perforated appendicitis
- Inflammatory marker C-reactive protein [ Time Frame: 24 and 48 hours post surgery ]Change in serum inflammatory marker C-reactive protein level after open surgery for perforated appendicitis
- Post-operative Ileus [ Time Frame: From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days ]Duration of post-operative ileus after open surgery for perforated appendicitis
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 13 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients between the age 13 and 70 years
- Diagnosed with perforated appendicitis intra-operatively
- Undergo open appendicectomy via Lanz incision
Exclusion Criteria:
- Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy
- Patients on steroid treatment and immunosuppressant therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512196
| Contact: Hari Sellappan, MB BCh BAO | +6088517555 | hari.vs@gmail.com |
| Malaysia | |
| Hospital Queen Elizabeth | Recruiting |
| Kota Kinabalu, Sabah, Malaysia, 88300 | |
| Contact: Hari Sellappan, MB BCh BAO 088517555 hari.vs@gmail.com | |
| Contact: Dinesh Alagoo, MBBS 088517555 | |
| Principal Investigator: | Hari Sellappan, MB BCh BAO | Hospital Queen Elizabeth, Kota Kinabalu, Sabah, Malaysia |
| Responsible Party: | Hospital Queen Elizabeth, Malaysia |
| ClinicalTrials.gov Identifier: | NCT04512196 |
| Other Study ID Numbers: |
NMRR-ID-16-2905-30891 |
| First Posted: | August 13, 2020 Key Record Dates |
| Last Update Posted: | August 25, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Perforated Appendicitis Super-oxidised solution Surgical site infection Peritoneal lavage |
|
Infections Appendicitis Surgical Wound Infection Intraabdominal Infections Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Cecal Diseases Intestinal Diseases Wound Infection Postoperative Complications Pathologic Processes |