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Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Milton S. Hershey Medical Center
Sponsor:
Collaborator:
American Society for Dermatologic Surgery
Information provided by (Responsible Party):
Joslyn S. Kirby, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01773694
First received: January 18, 2013
Last updated: March 14, 2016
Last verified: March 2016
History of Changes
  Purpose
Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is likely to decrease the risk of infection and bleeding. However, this has never been formally studied. Patient's routines are likely disrupted when they are asked to avoid wetting the area. The investigators will perform a controlled study to determine if avoidance of post-operative wetting is necessary.

Condition Intervention
Surgical Wound Infection
 Behavioral: Early Water Exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Post-operative wound infection [ Time Frame: Post-operative day 7 to 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of post-operative bleeding complications [ Time Frame: Post-operative day 7 to 14 ] [ Designated as safety issue: Yes ]
  • Scar appearance [ Time Frame: 6 months post-operatively (+-5 days) ] [ Designated as safety issue: No ]
    Using a non-invasive scoring tool, participants and a blinded physician will rate the appearance of the scar 6 months after the surgery.

  • Quality of Life [ Time Frame: Post-operative days 7 to14 ] [ Designated as safety issue: No ]
    Using a validated survey, information on the participants' quality of life will be assessed.
Estimated Enrollment: 914
Study Start Date: March 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early Water Exposure
The Intervention group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.
 Behavioral: Early Water Exposure

The Early Water Exposure (Intervention) group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.

On subsequent days, all participants, regardless of group assignment, will wash the wound daily with soap and water, reapply white petrolatum and a dry dressing.
No Intervention: Standard Care
The Standard Care group will receive standard wound care instructions and verbal education by the staff to keep the dressing dry and intact for 48 hours.

Detailed Description:

Physicians commonly instruct their patients to keep a wound dry for 2 to 3 days following surgery. The rationale may be that sources of water like a shower, bathtub, or swimming pool may increase the risk of infection. There may also be a concern that changing a dressing in the early post-operative period will increase the risk of bleeding complications. However, patient's routines and quality of life are disrupted when they are asked to avoid bathing, exercise, and swimming.

These issues have never been formally studied. This study will test the hypothesis of whether early post-operative wetting will have any influence on infection rates, bleeding complications, or the appearance of a surgical wound. Patients presenting to the Penn State Hershey dermatology clinic for the surgical removal of cancerous or non-cancerous skin lesions will be invited to participate. There will be no change to the standard surgical treatment. The dressing will be the same for all study participants. After surgery, study subjects who consent to participate will be randomized to receive one of two sets of post-operative instructions. One group will be directed to keep their initial post-operative dressing intact and dry for 48 hours. The second group will remove the dressing at 6 hours and wet the wound for 10 minutes in whatever manner they choose (shower, bath, pool, hot tub, etc.). After the initial dressing is removed (at 48 hours or 6 hours), both groups will perform identical post-operative care, consisting of cleansing the wound with soap and water followed by the application of petrolatum ointment and a dry dressing.

All participants will follow-up 7 to 14 days after surgery or earlier if they are experiencing any problems. At this time, the site will be assessed for clinical evidence of infection and bleeding. If the former is present, a bacterial culture will be obtained to confirm a wound infection and patients will be treated with an antibiotic. Physicians performing the assessment will be blinded to the patient's status (early wetting group or not). All subjects will also complete a questionnaire inquiring how and when they wet their wounds after surgery as well as two questionnaires asking how their quality-of-life and function were affected. Participants will again follow-up at 6 months when a blinded investigator will assess the cosmetic appearance of the scars using an established scar rating tool.

The data from this study will provide valuable evidence based guidance to surgeons in drafting wound care instructions for their patients. If the hypothesis proves correct, patients may be spared the inconvenience of post-operative water avoidance, diminishing the disruption to their lives caused by skin surgery.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. subjects are capable of giving informed consent

  2. patients undergoing any surgical treatment of benign and malignant lesions by any physician in the Dermatology department consisting of:

    1. standard excisional surgery or Mohs micrographic surgery with immediate reconstruction
    2. reconstruction with primary linear closure or adjacent tissue transfer with one or two layers of suture

Exclusion Criteria:

  1. pregnancy
  2. age younger than 18 years
  3. will not be returning to the dermatology clinic in 7-14 days for suture removal
  4. documented or suspected infection of the site prior to surgery
  5. current treatment with systemic antibiotic therapy
  6. staged excisions
  7. delayed or staged reconstructions
  8. wounds repaired with skin or cartilage grafts
  9. management with secondary intention healing
  10. surgical site on or near a mucosal surface where standard dressings are not typically used (eyelid, vermilion, etc.)
  11. patients receiving prophylactic antibiotics
  12. patients deemed on a case-by-case basis by their surgeon to have a high risk of post-operative bleeding and requiring prolonged application of a pressure dressing
  13. history of skin sensitivity or reaction to white petrolatum
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773694

Contacts
Contact: Amy Longenecker, RN, CCRC 717-531-5136
Contact: Sidone Keener, LPN 717-531-8307

Locations
United States, Pennsylvania
Department of Dermatology, Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Amy Longenecker, RN, CCRC    717-531-5136    alongenecker@hmc.psu.edu   
Sub-Investigator: Joslyn S Kirby, MD         
Principal Investigator: Todd V Cartee, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
American Society for Dermatologic Surgery
Investigators
Principal Investigator: Todd V Cartee, MD Milton S. Hershey Medical Center
Principal Investigator: Joslyn S Kirby, MD Milton S. Hershey Medical Center
  More Information

Publications:
Ratz, J.L. Textbook of dermatologic surgery, (Lippincott-Raven, Philadelphia, 1998).
Robinson, J.K. Surgery of the skin : procedural dermatology, (Elsevier Mosby, Philadelphia, 2005).

Responsible Party: Joslyn S. Kirby, Assistant Professor of Dermatology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01773694     History of Changes
Other Study ID Numbers: HMC IRB 38335EP 
Study First Received: January 18, 2013
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Milton S. Hershey Medical Center:
Post-operative management
Post-operative complications
Post-operative treatment
 water
skin
Dermatologic Surgical Procedures

Additional relevant MeSH terms:
Wound Infection
Surgical Wound Infection
Infection
 Wounds and Injuries
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2016