Sterile vs Clean Non-Sterile Wound Dressing in Orthopedic Surgery

NCT07436065 | Completed

• 1 other identifier: MRC-01-20-272
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infection (SSI)

Outcome Measures

Primary Outcomes (1)

• 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.

  Within six weeks after surgery

Secondary Outcomes (4)

• Duration of hospital stay

  From date of randomization until the date of discharge, assessed up to 6 weeks

• Readmission due to infection

  Within six weeks after surgery

• Reoperation rate due to infection

  Within six after surgery

• Comparative cost of dressing

  within six week

Study Arms (2)

Sterile Glove Dressing Technique

EXPERIMENTAL

Postoperative wound dressing changes performed using sterile glove while maintaining sterile instruments and sterile technique.

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.

Procedure: Clean Non-Sterile Glove Dressing Technique

Interventions

Sterile Glove Dressing Technique PROCEDURE

Postoperative wound dressing performed using sterile glove with standard aseptic technique

Sterile Glove Dressing Technique

Clean Non-Sterile Glove Dressing Technique PROCEDURE

Postoperative wound dressing performed using clean non-sterile glove with standard aseptic technique

Clean Non-sterile Glove Dressing Technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation, Surgical Specialty Center

Doha, Qatar

Location

Related Publications (12)

• 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.

  PMID: 28467526 BACKGROUND

• Perelman 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.

  PMID: 14985664 BACKGROUND

• Owens 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.

  PMID: 19022115 BACKGROUND

• Whitehead 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.

  PMID: 26092476 BACKGROUND

• Lawson 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.

  PMID: 12732741 BACKGROUND

• Brewer 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.

  PMID: 27487033 BACKGROUND

• Heal 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.

  PMID: 25588441 BACKGROUND

• Wound, 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.

  PMID: 22415169 BACKGROUND

• Kent 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.

  PMID: 29528884 BACKGROUND

• Dumville 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.

  PMID: 27996083 BACKGROUND

• Mangram 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.

  PMID: 10219875 BACKGROUND

• Hantouly 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.

  PMID: 40372454 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment, 1:1 randomized pilot study

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)