Clinical trial NCT01773694: Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries
Official title: Impact of Early Post-Operative Water Exposure on Complications of Cutaneous Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Post-operative management
Post-operative complications
Post-operative treatment
water
skin
Dermatologic Surgical Procedures
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: American Society for Dermatologic Surgery
First posted: 2013-01-23
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Post-operative wound infection
timeFrame: Post-operative day 7 to 14
Secondary outcomes:
measure: Incidence of post-operative bleeding complications
timeFrame: Post-operative day 7 to 14
measure: Scar appearance
timeFrame: 6 months post-operatively (+-5 days)
measure: Skin Specific Quality of Life
timeFrame: Post-operative days 7 to14
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Department of Dermatology, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Todd V Cartee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Milton S. Hershey Medical Center
name: Joslyn S Kirby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mudigonda T, Pearce DJ, Yentzer BA, Williford P, Feldman SR. The economic impact of non-melanoma skin cancer: a review. J Natl Compr Canc Netw. 2010 Aug;8(8):888-96. doi: 10.6004/jnccn.2010.0066.
citation: Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.
citation: Menke NB, Ward KR, Witten TM, Bonchev DG, Diegelmann RF. Impaired wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):19-25. doi: 10.1016/j.clindermatol.2006.12.005.
citation: WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. doi: 10.1038/193293a0. No abstract available.
citation: Ratz, J.L. Textbook of dermatologic surgery, (Lippincott-Raven, Philadelphia, 1998).
citation: Robinson, J.K. Surgery of the skin : procedural dermatology, (Elsevier Mosby, Philadelphia, 2005).
citation: Wolcott R, Dowd S. The role of biofilms: are we hitting the right target? Plast Reconstr Surg. 2011 Jan;127 Suppl 1:28S-35S. doi: 10.1097/PRS.0b013e3181fca244.
citation: Smack DP, Harrington AC, Dunn C, Howard RS, Szkutnik AJ, Krivda SJ, Caldwell JB, James WD. Infection and allergy incidence in ambulatory surgery patients using white petrolatum vs bacitracin ointment. A randomized controlled trial. JAMA. 1996 Sep 25;276(12):972-7.
citation: Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol. 1997 Nov;133(11):1433-40.
citation: Tsao S, Yao M, Tsao H, Henry FP, Zhao Y, Kochevar JJ, Redmond RW, Kochevar IE. Light-activated tissue bonding for excisional wound closure: a split-lesion clinical trial. Br J Dermatol. 2012 Mar;166(3):555-63. doi: 10.1111/j.1365-2133.2011.10710.x. Epub 2012 Jan 19.
citation: van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
citation: Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.