Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries
|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|
- Post-operative wound infection [ Time Frame: Post-operative day 7 to 14 ] [ Designated as safety issue: Yes ]
- 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.
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01773694
|Contact: Amy Longenecker, RN, CCRC||717-531-5136|
|Contact: Sidone Keener, LPN||717-531-8307|
|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 firstname.lastname@example.org|
|Sub-Investigator: Joslyn S Kirby, MD|
|Principal Investigator: Todd V Cartee, MD|
|Principal Investigator:||Todd V Cartee, MD||Milton S. Hershey Medical Center|
|Principal Investigator:||Joslyn S Kirby, MD||Milton S. Hershey Medical Center|