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Surgical Site InfectionPhase 3CHGNCT01495117

Study of Chlorhexidine Gluconate as a Preoperative Antisepsis

A Phase 3 study testing Povidone-Iodine and Chlorhexidine gluconate in people with Surgical Site Infection, run by Seung Duk Lee at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Surgical Site Infection
What is being tested?
Povidone-Iodine and Chlorhexidine gluconate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
534 participants
Where
1 siteSouth Korea
Study dates
Oct 2011to Oct 2014
Phase
Phase 3
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 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Resection of following organs (clean-contaminated open surgery)
  • Liver, Pancreas, Bile duct, Duodenum
  • Stomach
  • Colon, Small bowel
  • Aged 20 - 85 years old
  • Use Prophylactic antibiotics
Show all 14Show fewer
  • Use Preoperative bowel preparation
  • Elective operation
  • ASA classification 1-2 ASA I : no known systemic disease ASA II : single systemic disease \& mild or well controlled ASA III : multiple systemic diseases or moderately controlled systemic disease ASA IV : poorly controlled systemic diseases
  • adequate organ functions defined as indicated below:
  • WBC 3000 ~ 12 000/mm3
  • > Hb 8.0 g/dl
  • > Plt 100 000/mm3
  • < Cr 1.2 mg/dl

Who cannot join

  • allergy to chlorhexidine or povidone
  • clean surgery or contaminated surgery
  • patients who cannot be followed up during 1 month
  • patients taking immunosuppressant drugs or chemotherapy agents
  • emergent surgery and reoperation
  • uncontrolled diabetes, BMI > 30 kg/m2
  • vulnerable patients

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center, Republic of Korea

    Goyang-si, Gyeonggi-do, 410-769

Other trials in South Korea

About this study

Official title: Comparison of Chlorhexidine Gluconate and Povidone Iodine as a Preoperative Antisepsis in Clean-contaminated Abdominal Surgery : a Randomized Prospective Trial

The purpose of this study is to determine which drug (chlorhexidine gluconate vs. povidone iodine) as a preoperative antisepsis in clean-contaminated abdominal surgery (liver, hepatobiliary, small or large bowel, stomach) is effective.

Being tested
Povidone-Iodine, Chlorhexidine gluconate
Keywords
surgical site infection, chlorhexidine gluconate, povidone iodine
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.

  • Povidone-IodineDrug

    Also called 7.5% POVICLEAN BRUSH (SUNGKWANG PHARM), 10% POVIDONE IODINE SOLUTION (SUNGKWANG PHARM)

    7.5% povidone iodine soaping 10% povidone iodine painting

  • Chlorhexidine gluconateDrug

    Also called 4% HEXICLEN BRUSH (SUNGKWANG PHARM), 5% CHLORHEXIDINE GLUCONATE SOLUTION (SUNGKWANG PHARM)

    4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting

Study groups in NCT01495117
Study groupRoleWhat they receive
Povidone IodineActive comparator7.5% povidone iodine soaping 10% povidone iodine painting
Receives: Drug: Povidone-Iodine
Chlorhexidine GluconateActive comparator4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
Receives: Drug: Chlorhexidine gluconate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with Surgical Site infection within 1month

    Check the surgical site infection (SSI) rate within one month Superficial SSI, Deep SSI, Organ Site SSI decided by physician CDC Definition in 1999 Superficial incisional infection : involving only the skin or subcutaneous tissue of the incision Deep incisional Infection : involving the deep tissues (i.e. fascial and muscle layers) Organ Space Infection : involving any part of the anatomy (i.e. organ/space), other than the incision

    Measured: within 1 month

Secondary outcomes (3)

  1. Identify the infection source

    If SSI occur, we check the infection source including types of bacteriae using culture.

    Measured: within 1month

  2. Number of patients with Drug Side effect.

    We check the side effect of our drugs including chlorhexidine and povidione iodine.

    For example, itching sense, pruritis, ulticaria, redness, anaphylaxis

    Measured: Within 1 month

  3. Number of patients with the postoperative sepsis induced by wound infection

    Definition of Sepsis

    1. Proven infection (by culture, stain) or a clinical syndrome pathognomonic for infection (WBC, imaging finding or petechiae, purpura, or purpura fulminans)
    2. Body temperature (<36 or >38 Celsus Degree)
    3. Heart rate > 90 beats per minute
    4. Respiratory rate > 20 breaths per minute or, on blood gas, a PaCO2 less than 32 mmHg
    5. WBC count <4000 cells/mm3 or >12000 cells/mm3

    Measured: within 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01495117
Sponsor's protocol ID
NCCCTS-11-563
Acronym
CHG
Status last verified
Dec 2016
First submitted
14 Oct 2011
Last updated
21 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Park HM, Han SS, Lee EC, Lee SD, Yoon HM, Eom BW, Kim SH, Ryu KW, Park SJ, Kim YW, Park B. Randomized clinical trial of preoperative skin antisepsis with chlorhexidine gluconate or povidone-iodine. Br J Surg. 2017 Jan;104(2):e145-e150. doi: 10.1002/bjs.10395. Epub 2016 Nov 23.

    PubMed 27879993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Povidone-Iodine and Chlorhexidine gluconate in people with Surgical Site Infection, run by Seung Duk Lee at 1 site 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 14 inclusion and 7 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 21 Dec 2016. 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 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.

What does this phase mean?

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?

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?

Number of patients with Surgical Site infection within 1month (time frame: within 1 month). 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 NCT01495117, which also lists 1 linked publication.

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 21 Dec 2016.

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