Surgical Wound InfectionCOVERNCT03170843
Circular pOlyethylene Drape in preVention of Surgical Site infEction: A Randomized Controlled Trial
A study testing use of plastic ring wound retractor in people with Surgical Wound Infection, run by Saint Vincent's Hospital, Korea at 13 sites in South Korea.
Trial summary
This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- use of plastic ring wound retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 457 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 12 Jul 2017to 30 Sep 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age older than 18 years or less than 75 years
- either elective or emergent surgery for upper GI, small intestine, or colorectal disease
- open laparotomy
- the patient who agrees to participate in this trial
Who cannot join
- concurrent abdominal wall infection
- open conversion from laparoscopy
- poor nutritional status, NRS 2002 score 3
- combined hepatobiliary operation
- pregnant or breast-feeding state
- severe immunosuppression
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, 200-704
Keimyung University Dongsan Medical Center
Daegu, Gyeongsangbukdo, 41931
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444
Chonnam National University Hospital
Gwangju, Chonnam
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591
Chung-Ang University Hospital
Seoul
Eunpyeong St. Mary's hospital
Seoul
Yeouido St. Mary's hospital, The Catholic University of Korea
Seoul
St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
Ajou University of Hospital
Suwon, Gyeonggi-do
Ujeongbu St Mary's Hospital, The Catholic University of Korea
Uijeongbu-si, Gyeonggi-do, 480-717
About this study
Official title: Randomized Controlled Trial to Evaluate the Effectiveness and Efficacy of a Sterile Circular Polyethylene Drape Compared to Conventional Surgical Dressing in Prevention of Surgical Site Infection
This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.
Read the detailed description
Participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. If eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. The experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. Each participant will be blind to the randomization result because he/she will be under general anesthesia. Once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. Two groups will be compared for the surgical wound infection rate.
- Conditions
- Surgical Wound Infection
- Being tested
- use of plastic ring wound retractor
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of plastic ring wound retractorDevice
the experimental arm will use the plastic ring wound retractor for wound protection.
| Study group | Role | What they receive |
|---|---|---|
| O-Trac | Experimental | The experimental group will use the plastic ring wound retractor for wound protection during the surgery. Receives: Device: use of plastic ring wound retractor |
| Surgical pad | No intervention | The control group will use a conventional surgical pad for wound protection during the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of surgical wound infection
The rate of surgical wound infection will be monitored for each group.
Measured: within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start12 Jul 2017
- Primary completion11 Jul 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound 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 experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Jin Kim, Saint Vincent's Hospital, Korea
- Investigators
- HyungJin Kim, MD, Principal investigator, Eunpyeong St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170843
- Sponsor's protocol ID
- OTracSSI
- Acronym
- COVER
- Status last verified
- May 2023
- First submitted
- 26 May 2017
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mihaljevic AL, Michalski CW, Erkan M, Reiser-Erkan C, Jager C, Schuster T, Schuhmacher C, Kleeff J, Friess H. Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial. Trials. 2012 May 15;13:57. doi: 10.1186/1745-6215-13-57.
PubMed 22587425Mihaljevic AL, Schirren R, Ozer M, Ottl S, Grun S, Michalski CW, Erkan M, Jager C, Reiser-Erkan C, Kehl V, Schuster T, Roder J, Clauer U, Orlitsch C, Hoffmann TF, Lange R, Harzenetter T, Steiner P, Michalski M, Henkel K, Stadler J, Pistorius GA, Jahn A, Obermaier R, Unger R, Strunk R, Willeke F, Vogelsang H, Halve B, Dietl KH, Hilgenstock H, Meyer A, Kramling HJ, Wagner M, Schoenberg MH, Zeller F, Schmidt J, Friess H, Kleeff J. Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206). Ann Surg. 2014 Nov;260(5):730-7; discussion 737-9. doi: 10.1097/SLA.0000000000000954.
PubMed 25379844Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative; ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013 Jul 31;347:f4305. doi: 10.1136/bmj.f4305.
PubMed 23903454Yoo N, Mun JY, Kye BH, Kim CW, Lee JI, Park YY, Kang BM, Park BK, Kwak HD, Kang WK, Bae SU, Oh HK, Hong Y, Kim HJ. Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Jul 1;159(7):737-746. doi: 10.1001/jamasurg.2024.0765.
PubMed 38656413Yoo RN, Kim HJ, Lee JI, Kang WK, Kye BH, Kim CW, Bae SU, Nam S, Kang BM. Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial. BMJ Open. 2020 Jan 22;10(1):e034687. doi: 10.1136/bmjopen-2019-034687.
PubMed 31974091
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effectiveness and Efficacy of a Sterile Circular Polyethylene Drape Compared to Conventional Surgical Dressing in Prevention of Surgical Site Infection
- ClinicalTrials.gov ID
- NCT03170843
- Acronym / sponsor ID
- COVER / OTracSSI
- Conditions
- Surgical Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 31 May 2017 (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.
This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.
Detailed description
Participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. If eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. The experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. Each participant will be blind to the randomization result because he/she will be under general anesthesia. Once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. Two groups will be compared for the surgical wound infection rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.
| Arm | Type | Receives |
|---|---|---|
| O-Trac | Experimental | Device: use of plastic ring wound retractorThe experimental group will use the plastic ring wound retractor for wound protection during the surgery. |
| Surgical pad | No intervention | –The control group will use a conventional surgical pad for wound protection during the surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age older than 18 years or less than 75 years
- either elective or emergent surgery for upper GI, small intestine, or colorectal disease
- open laparotomy
- the patient who agrees to participate in this trial
Key exclusion criteria (6 listed)
- concurrent abdominal wall infection
- open conversion from laparoscopy
- poor nutritional status, NRS 2002 score 3
- combined hepatobiliary operation
- pregnant or breast-feeding state
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 |
|---|---|---|
| use of plastic ring wound retractorthe experimental arm will use the plastic ring wound retractor for wound protection. | Device | O-Trac |
Primary outcome
The rate of surgical wound infection
Time frame: within 30 days postoperative
The rate of surgical wound infection will be monitored for each group.
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 10 May 2023.
- Background: PubMed 22587425Mihaljevic AL, Michalski CW, Erkan M, Reiser-Erkan C, Jager C, Schuster T, Schuhmacher C, Kleeff J, Friess H. Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial. Trials. 2012 May 15;13:57. doi: 10.1186/1745-6215-13-57.
- Results publication: PubMed 25379844Mihaljevic AL, Schirren R, Ozer M, Ottl S, Grun S, Michalski CW, Erkan M, Jager C, Reiser-Erkan C, Kehl V, Schuster T, Roder J, Clauer U, Orlitsch C, Hoffmann TF, Lange R, Harzenetter T, Steiner P, Michalski M, Henkel K, Stadler J, Pistorius GA, Jahn A, Obermaier R, Unger R, Strunk R, Willeke F, Vogelsang H, Halve B, Dietl KH, Hilgenstock H, Meyer A, Kramling HJ, Wagner M, Schoenberg MH, Zeller F, Schmidt J, Friess H, Kleeff J. Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206). Ann Surg. 2014 Nov;260(5):730-7; discussion 737-9. doi: 10.1097/SLA.0000000000000954.
- Results publication: PubMed 23903454Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative; ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013 Jul 31;347:f4305. doi: 10.1136/bmj.f4305.
- Derived from this study: PubMed 38656413Yoo N, Mun JY, Kye BH, Kim CW, Lee JI, Park YY, Kang BM, Park BK, Kwak HD, Kang WK, Bae SU, Oh HK, Hong Y, Kim HJ. Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Jul 1;159(7):737-746. doi: 10.1001/jamasurg.2024.0765.
- Derived from this study: PubMed 31974091Yoo RN, Kim HJ, Lee JI, Kang WK, Kye BH, Kim CW, Bae SU, Nam S, Kang BM. Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial. BMJ Open. 2020 Jan 22;10(1):e034687. doi: 10.1136/bmjopen-2019-034687.
- 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. This study is not recruiting at the moment.
HyungJin Kim, MD principal investigator
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of plastic ring wound retractor in people with Surgical Wound Infection, run by Saint Vincent's Hospital, Korea at 13 sites in South Korea.
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 4 inclusion and 6 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. 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?
The rate of surgical wound infection (time frame: within 30 days postoperative). 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 NCT03170843, which also lists 5 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 10 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.