Surgical Site Infection (SSI)NCT07436065
Sterile vs Clean Non-Sterile Wound Dressing in Orthopedic Surgery
A study testing Sterile Glove Dressing Technique and Clean Non-Sterile Glove Dressing Technique in people with Surgical Site Infection (SSI), run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
This randomized interventional pilot study aims to compare the rate of significant Surgical Site Infection (SSI) within the six weeks after elective orthopedic surgery using sterile versus clean non-sterile glove postoperative dressing techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgical Site Infection (SSI)
- What is being tested?
- Sterile Glove Dressing Technique and Clean Non-Sterile Glove Dressing Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2021to 14 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 and less than 65 years,
- knee arthroscopy, ACL reconstruction or isolated fracture fixation,
- Operating time < 2 hours,
- Patients with American Society of Anesthesiogists Classification (ASA):ASA 0 to ASA1,
- Non smoker,
- No previous surgical scar in the knee,
- Informed consent.
Who cannot join
- Any patient that has, previous superficial or deep infection at the site of surgery,
- Diabetes mellitus,
- Obesity (BMI > 40 kg/m2)
- Immune-compromised,
- Previous superficial or deep infection at the site of surgery,
- Polytrauma,
Show all 11Show fewer
- Transfusion of blood products,
- Revision procedure,
- Patient preparation-related factor (inadequate antiseptic skin preparation, preoperative hair removal)
- Skin disease at the operative site.
- Contaminated wounds.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Orthopedic Wound Dressing Using Sterile Versus Clean Non-sterile Techniques At Hamad General Hospital. A Prospective Pilot Study
This randomized interventional pilot study aims to compare the rate of significant Surgical Site Infection (SSI) within the six weeks after elective orthopedic surgery using sterile versus clean non-sterile glove postoperative dressing techniques.
Read the detailed description
Surgical site infections (SSIs) following orthopaedic surgeries is not uncommon. If an infection occurs, it may lead to debilitating results, increased re-operations, hospital stay, and healthcare costs. SSI was defined by the Centers for Disease Control and Prevention/ National Nosocomial Infections Surveillance system. The definition included superficial and deep SSI with an onset within 30 days and 12 months, respectively, after the operation.
Because there is no current standard of care to use sterile or clean nonsterile technique for wound care and dressing following elective orthopaedic procedures, further studies are needed to determine which technique is more effective in preventing acute SSI.
The sterile technique was defined in a systematic review by Kent by the use of sterile field, sterile gloves, and sterile instruments. Whereas clean technique implies the use of a clean procedure field, clean non-sterile gloves and ensuring that the gloves, field, and supplies are free of contamination. Some studies have compared the use of sterile and clean non-sterile techniques to determine the effect on wound infections in cutaneous surgical procedures and chronic wounds. One study reported the SSI rate of 2.02% and 4.6% in patients underwent contaminated laceration wound repair using sterile and clean non-sterile techniques, respectively. The incidence of infection was not significantly different between the two groups.
A Systematic Review and Meta-analysis have concluded that there was no difference in the rate of infection between outpatient surgical procedures performed with sterile versus non-sterile gloves. Other studies concluded that each health care organization has to establish its own guidelines for wound care because the existing evidence base does not support the preferential selection of either technique. A prospective randomized controlled study had concluded that clean non-sterile gloves are not inferior to sterile gloves for minor skin excisions in general practice regarding SSI.
To the best of the investigators knowledge, there are no studies available that have compared the rate of acute postoperative SSI between the use of sterile versus clean non-sterile gloves for wound care and dressing after knee arthroscopy +/- ACL reconstruction (infection rate is low (0.14%-1.7%) following ACL reconstruction) and simple fracture fixation . This pilot study aims to evaluate the rate of acute SSI following this elective orthopedic procedures in sterile versus clean non-sterile techniques.
Hypothesis:
No difference in the rate of SSI between the use of sterile or clean non-sterile techniques following knee arthroscopy +\- ACL reconstruction and isolated fracture fixation for wound care and dressing.
Method:
The study will be designed as a prospective pilot study to compare the rate of acute SSI up to 6 weeks following knee arthroscopy, ACL reconstruction or simple isolated fracture fixation between the use of sterile versus clean non-sterile techniques for wound care and dressing. The main reason behind this design is that no previous studies reported the rate of acute SSI following the aforementioned procedures. All patients will be treated using the same postoperative protocol. Dressing will be changed once by the one specialist nurse practitioner on day 5 after the procedure. Patients will be assessed in the outpatient clinic on day 14 for dressing changes and for suture removal. The final assessment will be at the outpatient visit on week six postoperatively. Adult patients (age >= 18) who will undergo clean knee arthroscopy, ACL repair or isolated fracture fixation at orthopaedic surgery ward of Hamad General Hospital will be screened for recruitment. Patients who meet the inclusion criteria and are willing to participate in the study will be asked to sign a consent form. Once a patient is eligible for recruitment, informed consent will be obtained. The randomization sequence will be generated beforehand and the allocated treatments will be in sealed opaque envelopes. A sealed envelope will be opened and the allocated treatment will consist of either dressing change with the use of sterile or clean non-sterile technique during the post-operative course. Neither patients nor the research team will be blinded for dressing type.
Baseline variables that will be collected include:
- Patient demographics
- Type of elective orthopaedic procedure
- Duration of the operation
- Estimated blood loss
- Number of dressing changes and which days
- Preventive measure such as pre-op staph aureus decolonization, dental check-up, hair removal, nutrition status will be screened before the surgery.
Postoperative wound dressing changes will be performed using sterile gloves in the sterile group and clean non-sterile gloves in the comparative group. Sterile instruments and aseptic field technique will be used in both groups. All dressings will be applied by a single trained orthopedic wound nurse.
The first dressing change will be performed only on postoperative day five, with follow-up assessments at two and six weeks. All wounds will be dressed using Mepilex® Border Flex (7.5 × 7.5 cm). Hand hygiene follows World Health Organization guidelines, and wounds will be cleansed with Chlorhexidine prior to dressing application. Laboratory testing including white blood cell count, C-reactive protein and wound cultures were obtained if infection was suspected.
Patients will be followed during the hospital stay, 2 weeks and 6 weeks after the procedure. At each follow-up visit, SSI indicators will be collected and laboratory tests will be done only for patient with high clinical suspicion of infection, as part of routine patient care. White blood cell count, c-reactive protein and wound culture will obtained in patient who have clinical indications of SSI.
The investigators will document any other operative complications and re-operations or re-admission during the postoperative 6 weeks as well.
Significant SSIs were assessed by investigators using a standardized wound scoring system: grade 0 indicated no or slight erythema, grade 1 indicated erythema ≤1 cm from the incision line not requiring antibiotics, grade 2 indicated erythema >1 cm with or without edema requiring systemic antibiotics, and grade 3 indicated purulent discharge with requiring surgical debridement in addition to antibiotics.
Grades 2 and 3 will be considered clinically significant SSI.
- Conditions
- Surgical Site Infection (SSI)
- Being tested
- Sterile Glove Dressing Technique, Clean Non-Sterile Glove Dressing Technique
- 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.
Sterile Glove Dressing TechniqueProcedure or surgery
Postoperative wound dressing performed using sterile glove with standard aseptic technique
Clean Non-Sterile Glove Dressing TechniqueProcedure or surgery
Postoperative wound dressing performed using clean non-sterile glove with standard aseptic technique
| Study group | Role | What they receive |
|---|---|---|
| Sterile Glove Dressing Technique | Experimental | Postoperative wound dressing changes performed using sterile glove while maintaining sterile instruments and sterile technique. Receives: Procedure: Sterile Glove Dressing Technique |
| Clean Non-sterile Glove Dressing Technique | Active comparator | Postoperative wound dressing changes performed using clean non-sterile gloves while maintaining sterile instruments and sterile field technique. Receives: Procedure: Clean Non-Sterile Glove Dressing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Surgical Site Infection
The CDC defines an SSI as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved).
Incisional SSIs are further divided into those involving only skin and subcutaneous tissues (superficial incisional SSI) and those involving deeper softer tissues of the incision (deep incisional SSI).
SSIs will be assessed using a standardized wound scoring system:
Grade 0 indicated no or slight erythema Grade 1 indicated erythema ≤1 cm from the incision line not requiring antibiotics Grade 2 indicated erythema >1 cm with or without edema requiring systemic antibiotics Grade 3 indicated purulent discharge requiring surgical debridement in addition to antibiotics.
Grades 2 and 3 will be considered clinically significant.
Measured: Within six weeks after surgery
Secondary outcomes (4)
Duration of hospital stay
Measured: From date of randomization until the date of discharge, assessed up to 6 weeks
Readmission due to infection
Measured: Within six weeks after surgery
Reoperation rate due to infection
Measured: Within six after surgery
Comparative cost of dressing
Direct material cost from the hospital perspective in Qatari Riyals per patient
Measured: within six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2021
- Primary completion14 Dec 2022
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Parallel assignment, 1:1 randomized pilot study
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ghalib Ahmed, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436065
- Sponsor's protocol ID
- MRC-01-20-272
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
PubMed 28467526Perelman VS, Francis GJ, Rutledge T, Foote J, Martino F, Dranitsaris G. Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the emergency department: a randomized controlled trial. Ann Emerg Med. 2004 Mar;43(3):362-70. doi: 10.1016/j.annemergmed.2003.09.008.
PubMed 14985664Owens CD, Stoessel K. Surgical site infections: epidemiology, microbiology and prevention. J Hosp Infect. 2008 Nov;70 Suppl 2:3-10. doi: 10.1016/S0195-6701(08)60017-1.
PubMed 19022115Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476Lawson C, Juliano L, Ratliff CR. Does sterile or nonsterile technique make a difference in wounds healing by secondary intention? Ostomy Wound Manage. 2003 Apr;49(4):56-8, 60.
PubMed 12732741Brewer JD, Gonzalez AB, Baum CL, Arpey CJ, Roenigk RK, Otley CC, Erwin PJ. Comparison of Sterile vs Nonsterile Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures: A Systematic Review and Meta-analysis. JAMA Dermatol. 2016 Sep 1;152(9):1008-14. doi: 10.1001/jamadermatol.2016.1965.
PubMed 27487033Heal C, Sriharan S, Buttner PG, Kimber D. Comparing non-sterile to sterile gloves for minor surgery: a prospective randomised controlled non-inferiority trial. Med J Aust. 2015 Jan 19;202(1):27-31. doi: 10.5694/mja14.00314.
PubMed 25588441Wound, Ostomy and Continence Nurses Society (WOCN) Wound Committee; Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) 2000 Guidelines Committee. Clean vs. sterile dressing techniques for management of chronic wounds: a fact sheet. J Wound Ostomy Continence Nurs. 2012 Mar-Apr;39(2 Suppl):S30-4. doi: 10.1097/WON.0b013e3182478e06. No abstract available.
PubMed 22415169Kent DJ, Scardillo JN, Dale B, Pike C. Does the Use of Clean or Sterile Dressing Technique Affect the Incidence of Wound Infection? J Wound Ostomy Continence Nurs. 2018 May/Jun;45(3):265-269. doi: 10.1097/WON.0000000000000425.
PubMed 29528884Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T, Macefield R, Blencowe N, Milne TK, Reeves BC, Blazeby J. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD003091. doi: 10.1002/14651858.CD003091.pub4.
PubMed 27996083Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
PubMed 10219875Hantouly AT, Muthu S, Lawand J, Alzobi O, Alebbini M, Hoveidaei AH, Karimi M, Hameed S, Ahmed G, Citak M. The impact of surgical approach in total hip arthroplasty on the organisms profile of periprosthetic joint infections? A systematic review and meta-analysis. Arch Orthop Trauma Surg. 2025 May 15;145(1):293. doi: 10.1007/s00402-025-05881-1.
PubMed 40372454
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Orthopedic Wound Dressing Using Sterile Versus Clean Non-sterile Techniques At Hamad General Hospital. A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07436065
- Acronym / sponsor ID
- MRC-01-20-272
- Conditions
- Surgical Site Infection (SSI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 27 Feb 2026 (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 randomized interventional pilot study aims to compare the rate of significant Surgical Site Infection (SSI) within the six weeks after elective orthopedic surgery using sterile versus clean non-sterile glove postoperative dressing techniques.
Detailed description
Surgical site infections (SSIs) following orthopaedic surgeries is not uncommon. If an infection occurs, it may lead to debilitating results, increased re-operations, hospital stay, and healthcare costs. SSI was defined by the Centers for Disease Control and Prevention/ National Nosocomial Infections Surveillance system. The definition included superficial and deep SSI with an onset within 30 days and 12 months, respectively, after the operation.
Because there is no current standard of care to use sterile or clean nonsterile technique for wound care and dressing following elective orthopaedic procedures, further studies are needed to determine which technique is more effective in preventing acute SSI.
The sterile technique was defined in a systematic review by Kent by the use of sterile field, sterile gloves, and sterile instruments. Whereas clean technique implies the use of a clean procedure field, clean non-sterile gloves and ensuring that the gloves, field, and supplies are free of contamination. Some studies have compared the use of sterile and clean non-sterile techniques to determine the effect on wound infections in cutaneous surgical procedures and chronic wounds. One study reported the SSI rate of 2.02% and 4.6% in patients underwent contaminated laceration wound repair using sterile and clean non-sterile techniques, respectively. The incidence of infection was not significantly different between the two groups.
A Systematic Review and Meta-analysis have concluded that there was no difference in the rate of infection between outpatient surgical procedures performed with sterile versus non-sterile gloves. Other studies concluded that each health care organization has to establish its own guidelines for wound care because the existing evidence base does not support the preferential selection of either technique. A prospective randomized controlled study had concluded that clean non-sterile gloves are not inferior to sterile gloves for minor skin excisions in general practice regarding SSI.
To the best of the investigators knowledge, there are no studies available that have compared the rate of acute postoperative SSI between the use of sterile versus clean non-sterile gloves for wound care and dressing after knee arthroscopy +/- ACL reconstruction (infection rate is low (0.14%-1.7%) following ACL reconstruction) and simple fracture fixation . This pilot study aims to evaluate the rate of acute SSI following this elective orthopedic procedures in sterile versus clean non-sterile techniques.
Hypothesis:
No difference in the rate of SSI between the use of sterile or clean non-sterile techniques following knee arthroscopy +\- ACL reconstruction and isolated fracture fixation for wound care and dressing.
Method:
The study will be designed as a prospective pilot study to compare the rate of acute SSI up to 6 weeks following knee arthroscopy, ACL reconstruction or simple isolated fracture fixation between the use of sterile versus clean non-sterile techniques for wound care and dressing. The main reason behind this design is that no previous studies reported the rate of acute SSI following the aforementioned procedures. All patients will be treated using the same postoperative protocol. Dressing will be changed once by the one specialist nurse practitioner on day 5 after the procedure. Patients will be assessed in the outpatient clinic on day 14 for dressing changes and for suture removal. The final assessment will be at the outpatient visit on week six postoperatively. Adult patients (age >= 18) who will undergo clean knee arthroscopy, ACL repair or isolated fracture fixation at orthopaedic surgery ward of Hamad General Hospital will be screened for recruitment. Patients who meet the inclusion criteria and are willing to participate in the study will be asked to sign a consent form. Once a patient is eligible for recruitment, informed consent will be obtained. The randomization sequence will be generated beforehand and the allocated treatments will be in sealed opaque envelopes. A sealed envelope will be opened and the allocated treatment will consist of either dressing change with the use of sterile or clean non-sterile technique during the post-operative course. Neither patients nor the research team will be blinded for dressing type.
Baseline variables that will be collected include:
- Patient demographics
- Type of elective orthopaedic procedure
- Duration of the operation
- Estimated blood loss
- Number of dressing changes and which days
- Preventive measure such as pre-op staph aureus decolonization, dental check-up, hair removal, nutrition status will be screened before the surgery.
Postoperative wound dressing changes will be performed using sterile gloves in the sterile group and clean non-sterile gloves in the comparative group. Sterile instruments and aseptic field technique will be used in both groups. All dressings will be applied by a single trained orthopedic wound nurse.
The first dressing change will be performed only on postoperative day five, with follow-up assessments at two and six weeks. All wounds will be dressed using Mepilex® Border Flex (7.5 × 7.5 cm). Hand hygiene follows World Health Organization guidelines, and wounds will be cleansed with Chlorhexidine prior to dressing application. Laboratory testing including white blood cell count, C-reactive protein and wound cultures were obtained if infection was suspected.
Patients will be followed during the hospital stay, 2 weeks and 6 weeks after the procedure. At each follow-up visit, SSI indicators will be collected and laboratory tests will be done only for patient with high clinical suspicion of infection, as part of routine patient care. White blood cell count, c-reactive protein and wound culture will obtained in patient who have clinical indications of SSI.
The investigators will document any other operative complications and re-operations or re-admission during the postoperative 6 weeks as well.
Significant SSIs were assessed by investigators using a standardized wound scoring system: grade 0 indicated no or slight erythema, grade 1 indicated erythema ≤1 cm from the incision line not requiring antibiotics, grade 2 indicated erythema >1 cm with or without edema requiring systemic antibiotics, and grade 3 indicated purulent discharge with requiring surgical debridement in addition to antibiotics.
Grades 2 and 3 will be considered clinically significant SSI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment, 1:1 randomized pilot study
| Arm | Type | Receives |
|---|---|---|
| Sterile Glove Dressing Technique | Experimental | Procedure: Sterile Glove Dressing TechniquePostoperative wound dressing changes performed using sterile glove while maintaining sterile instruments and sterile technique. |
| Clean Non-sterile Glove Dressing Technique | Active comparator | Procedure: Clean Non-Sterile Glove Dressing TechniquePostoperative wound dressing changes performed using clean non-sterile gloves while maintaining sterile instruments and sterile field technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age more than 18 and less than 65 years,
- knee arthroscopy, ACL reconstruction or isolated fracture fixation,
- Operating time < 2 hours,
- Patients with American Society of Anesthesiogists Classification (ASA):ASA 0 to ASA1,
- Non smoker,
Key exclusion criteria (11 listed)
- Any patient that has, previous superficial or deep infection at the site of surgery,
- Diabetes mellitus,
- Obesity (BMI > 40 kg/m2)
- Immune-compromised,
- Previous superficial or deep infection at the site of surgery,
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 |
|---|---|---|
| Sterile Glove Dressing TechniquePostoperative wound dressing performed using sterile glove with standard aseptic technique | Procedure or surgery | Sterile Glove Dressing Technique |
| Clean Non-Sterile Glove Dressing TechniquePostoperative wound dressing performed using clean non-sterile glove with standard aseptic technique | Procedure or surgery | Clean Non-sterile Glove Dressing Technique |
Primary outcome
Incidence rate of Surgical Site Infection
Time frame: Within six weeks after surgery
The CDC defines an SSI as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved). Incisional SSIs are further divided into those involving only skin and subcutaneous tissues (superficial incisional SSI) and those involving deeper softer tissues of the incision (deep incisional SSI). SSIs will be assessed using a standardized wound scoring system: Grade 0 indicated no or slight erythema Grade 1 indicated erythema ≤1 cm from the incision line not requiring antibiotics Grade 2 indicated erythema >1 cm with or without edema requiring systemic antibiotics Grade 3 indicated purulent discharge requiring surgical debridement in addition to antibiotics. Grades 2 and 3 will be considered clinically significant.
4 secondary outcomes
Duration of hospital stay
Time frame: From date of randomization until the date of discharge, assessed up to 6 weeks
Readmission due to infection
Time frame: Within six weeks after surgery
Reoperation rate due to infection
Time frame: Within six after surgery
Comparative cost of dressing
Time frame: within six week
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 27 Feb 2026.
- Background: PubMed 28467526Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
- Background: PubMed 14985664Perelman VS, Francis GJ, Rutledge T, Foote J, Martino F, Dranitsaris G. Sterile versus nonsterile gloves for repair of uncomplicated lacerations in the emergency department: a randomized controlled trial. Ann Emerg Med. 2004 Mar;43(3):362-70. doi: 10.1016/j.annemergmed.2003.09.008.
- Background: PubMed 19022115Owens CD, Stoessel K. Surgical site infections: epidemiology, microbiology and prevention. J Hosp Infect. 2008 Nov;70 Suppl 2:3-10. doi: 10.1016/S0195-6701(08)60017-1.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Background: PubMed 12732741Lawson C, Juliano L, Ratliff CR. Does sterile or nonsterile technique make a difference in wounds healing by secondary intention? Ostomy Wound Manage. 2003 Apr;49(4):56-8, 60.
- Background: PubMed 27487033Brewer JD, Gonzalez AB, Baum CL, Arpey CJ, Roenigk RK, Otley CC, Erwin PJ. Comparison of Sterile vs Nonsterile Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures: A Systematic Review and Meta-analysis. JAMA Dermatol. 2016 Sep 1;152(9):1008-14. doi: 10.1001/jamadermatol.2016.1965.
- Background: PubMed 25588441Heal C, Sriharan S, Buttner PG, Kimber D. Comparing non-sterile to sterile gloves for minor surgery: a prospective randomised controlled non-inferiority trial. Med J Aust. 2015 Jan 19;202(1):27-31. doi: 10.5694/mja14.00314.
- Background: PubMed 22415169Wound, Ostomy and Continence Nurses Society (WOCN) Wound Committee; Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) 2000 Guidelines Committee. Clean vs. sterile dressing techniques for management of chronic wounds: a fact sheet. J Wound Ostomy Continence Nurs. 2012 Mar-Apr;39(2 Suppl):S30-4. doi: 10.1097/WON.0b013e3182478e06. No abstract available.
- Background: PubMed 29528884Kent DJ, Scardillo JN, Dale B, Pike C. Does the Use of Clean or Sterile Dressing Technique Affect the Incidence of Wound Infection? J Wound Ostomy Continence Nurs. 2018 May/Jun;45(3):265-269. doi: 10.1097/WON.0000000000000425.
- Background: PubMed 27996083Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T, Macefield R, Blencowe N, Milne TK, Reeves BC, Blazeby J. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD003091. doi: 10.1002/14651858.CD003091.pub4.
- Background: PubMed 10219875Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
- Background: PubMed 40372454Hantouly AT, Muthu S, Lawand J, Alzobi O, Alebbini M, Hoveidaei AH, Karimi M, Hameed S, Ahmed G, Citak M. The impact of surgical approach in total hip arthroplasty on the organisms profile of periprosthetic joint infections? A systematic review and meta-analysis. Arch Orthop Trauma Surg. 2025 May 15;145(1):293. doi: 10.1007/s00402-025-05881-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Glove Dressing Technique and Clean Non-Sterile Glove Dressing Technique in people with Surgical Site Infection (SSI), run by Hamad Medical Corporation at 1 site in Qatar.
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 7 inclusion and 11 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 27 Feb 2026. 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 Qatar. 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?
Incidence rate of Surgical Site Infection (time frame: Within six weeks after surgery). 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 NCT07436065, which also lists 12 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 27 Feb 2026.