Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/25/2018 |
Start Date: | March 2013 |
End Date: | January 2020 |
Contact: | Amy Longenecker, RN, CCRC |
Phone: | 717-531-5136 |
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.
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.
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.
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.
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
We found this trial at
1
site
Hershey, Pennsylvania 17033
Phone: 717-531-5136
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